{"month": "2026-08", "count": 600, "recalls": [{"id": "fda-food-h-0163-2027", "source": "FDA", "category": "food", "recall_number": "H-0163-2027", "title": "Wheat Germ recall (El Ruisenor De Mexico, Inc.)", "product": "Wheat Germ; packaged in 1lb, 5lb, 50lb clear plastic units.  No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "11 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0163-2027%22", "url": "https://recallledger.net/recalls/food-h-0163-2027-wheat-germ-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0162-2027", "source": "FDA", "category": "food", "recall_number": "H-0162-2027", "title": "Whole wheat flour recall (El Ruisenor De Mexico, Inc.)", "product": "Whole wheat flour; packaged in 1lb, 5lb, 50lb clear plastic units.  No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "237 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0162-2027%22", "url": "https://recallledger.net/recalls/food-h-0162-2027-whole-wheat-flour-packaged-in-1lb-5lb-50lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0161-2027", "source": "FDA", "category": "food", "recall_number": "H-0161-2027", "title": "Tube Shaped Wheat Snack recall (El Ruisenor De Mexico, Inc.)", "product": "Tube Shaped Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units.  No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "37 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0161-2027%22", "url": "https://recallledger.net/recalls/food-h-0161-2027-tube-shaped-wheat-snack-packaged-in-1lb-5lb-33lb-clear-plastic-unit/"}, {"id": "fda-food-h-0160-2027", "source": "FDA", "category": "food", "recall_number": "H-0160-2027", "title": "4X6 Wheat Snack recall (El Ruisenor De Mexico, Inc.)", "product": "4X6 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. 4X8 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units.  No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "608 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0160-2027%22", "url": "https://recallledger.net/recalls/food-h-0160-2027-4x6-wheat-snack-packaged-in-1lb-5lb-33lb-clear-plastic-units-4x8-w/"}, {"id": "fda-food-h-0159-2027", "source": "FDA", "category": "food", "recall_number": "H-0159-2027", "title": "10X10 Wheat Snack recall (El Ruisenor De Mexico, Inc.)", "product": "10X10 Wheat Snack; packaged in 2lb, 5lb, 33lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "942 pounds", "codes": "lot: 028 1 26 6 213", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0159-2027%22", "url": "https://recallledger.net/recalls/food-h-0159-2027-10x10-wheat-snack-packaged-in-2lb-5lb-33lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0158-2027", "source": "FDA", "category": "food", "recall_number": "H-0158-2027", "title": "Milk Chocolate Covered Raisins recall (El Ruisenor De Mexico, Inc.)", "product": "Milk Chocolate Covered Raisins; packaged in 1lb, 5lb, 20lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Milk, Soy)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "61.37 pounds", "codes": "lot: 630-715", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0158-2027%22", "url": "https://recallledger.net/recalls/food-h-0158-2027-milk-chocolate-covered-raisins-packaged-in-1lb-5lb-20lb-clear-plast/"}, {"id": "fda-food-h-0157-2027", "source": "FDA", "category": "food", "recall_number": "H-0157-2027", "title": "Tropical Trail Mix recall (El Ruisenor De Mexico, Inc.)", "product": "Tropical Trail Mix; packaged in 1lb, 5lb, 25lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Peanuts, Almonds, Sulfites, Yellow#6)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "903.71 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0157-2027%22", "url": "https://recallledger.net/recalls/food-h-0157-2027-tropical-trail-mix-packaged-in-1lb-5lb-25lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0156-2027", "source": "FDA", "category": "food", "recall_number": "H-0156-2027", "title": "Whole Wheat recall (El Ruisenor De Mexico, Inc.)", "product": "Whole Wheat; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2,231 pounds", "codes": "lot: 124624", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0156-2027%22", "url": "https://recallledger.net/recalls/food-h-0156-2027-whole-wheat-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0155-2027", "source": "FDA", "category": "food", "recall_number": "H-0155-2027", "title": "Textured Soy Protein recall (El Ruisenor De Mexico, Inc.)", "product": "Textured Soy Protein; packaged in 1lb, 5lb, 33lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Soy)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "123.5 pounds", "codes": "A-15-26", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0155-2027%22", "url": "https://recallledger.net/recalls/food-h-0155-2027-textured-soy-protein-packaged-in-1lb-5lb-33lb-clear-plastic-units/"}, {"id": "fda-food-h-0154-2027", "source": "FDA", "category": "food", "recall_number": "H-0154-2027", "title": "Wheat Bran recall (El Ruisenor De Mexico, Inc.)", "product": "Wheat Bran; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "128.10 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0154-2027%22", "url": "https://recallledger.net/recalls/food-h-0154-2027-wheat-bran-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0153-2027", "source": "FDA", "category": "food", "recall_number": "H-0153-2027", "title": "Raw Shelled Pistachios recall (El Ruisenor De Mexico, Inc.)", "product": "Raw Shelled Pistachios; packaged in 1lb, 5lb, 25-30lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Pistachios)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "759 pounds", "codes": "lot: 261245XXX18L04A", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0153-2027%22", "url": "https://recallledger.net/recalls/food-h-0153-2027-raw-shelled-pistachios-packaged-in-1lb-5lb-25-30lb-clear-plastic-un/"}, {"id": "fda-food-h-0152-2027", "source": "FDA", "category": "food", "recall_number": "H-0152-2027", "title": "Shelled White Pine Nuts recall (El Ruisenor De Mexico, Inc.)", "product": "Shelled White Pine Nuts; packaged in 1lb, 5lb, 25-55lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Pine Nuts)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "11.75 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0152-2027%22", "url": "https://recallledger.net/recalls/food-h-0152-2027-shelled-white-pine-nuts-packaged-in-1lb-5lb-25-55lb-clear-plastic-u/"}, {"id": "fda-food-h-0151-2027", "source": "FDA", "category": "food", "recall_number": "H-0151-2027", "title": "Dried Pineapple Rings recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Pineapple Rings; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "133.05 pounds", "codes": "lot: 15052", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0151-2027%22", "url": "https://recallledger.net/recalls/food-h-0151-2027-dried-pineapple-rings-packaged-in-1lb-5lb-44lb-clear-plastic-units/"}, {"id": "fda-food-h-0150-2027", "source": "FDA", "category": "food", "recall_number": "H-0150-2027", "title": "Dried Diced Pineapple recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Diced Pineapple; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "69 pounds", "codes": "lot: 14929", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0150-2027%22", "url": "https://recallledger.net/recalls/food-h-0150-2027-dried-diced-pineapple-packaged-in-1lb-5lb-44lb-clear-plastic-units/"}, {"id": "fda-food-h-0149-2027", "source": "FDA", "category": "food", "recall_number": "H-0149-2027", "title": "Dried Pears recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Pears; packaged in 1lb, 5lb, 25lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "59 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0149-2027%22", "url": "https://recallledger.net/recalls/food-h-0149-2027-dried-pears-packaged-in-1lb-5lb-25lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0148-2027", "source": "FDA", "category": "food", "recall_number": "H-0148-2027", "title": "Dried Papaya Spears recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Papaya Spears; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Yellow#6, Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "225 pounds", "codes": "lot: 14968", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0148-2027%22", "url": "https://recallledger.net/recalls/food-h-0148-2027-dried-papaya-spears-packaged-in-1lb-5lb-44lb-clear-plastic-units-n/"}, {"id": "fda-food-h-0147-2027", "source": "FDA", "category": "food", "recall_number": "H-0147-2027", "title": "Dried Diced Papaya recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Diced Papaya; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Yellow#6, Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "26 pounds", "codes": "lot: 15132", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0147-2027%22", "url": "https://recallledger.net/recalls/food-h-0147-2027-dried-diced-papaya-packaged-in-1lb-5lb-44lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0146-2027", "source": "FDA", "category": "food", "recall_number": "H-0146-2027", "title": "Bread Crumbs recall (El Ruisenor De Mexico, Inc.)", "product": "Bread Crumbs; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Milk, Wheat, Sesame, Soy)", "hazard_level": "Class I", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1,354 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0146-2027%22", "url": "https://recallledger.net/recalls/food-h-0146-2027-bread-crumbs-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0145-2027", "source": "FDA", "category": "food", "recall_number": "H-0145-2027", "title": "Pecans in Shell recall (El Ruisenor De Mexico, Inc.)", "product": "Pecans in Shell; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Pecans)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "628 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0145-2027%22", "url": "https://recallledger.net/recalls/food-h-0145-2027-pecans-in-shell-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-up/"}, {"id": "fda-food-h-0144-2027", "source": "FDA", "category": "food", "recall_number": "H-0144-2027", "title": "Walnut halves recall (El Ruisenor De Mexico, Inc.)", "product": "Walnut halves; packaged in 1lb, 5lb, 22-25lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Walnuts)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "212.50 pounds", "codes": "lot: KP02036", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0144-2027%22", "url": "https://recallledger.net/recalls/food-h-0144-2027-walnut-halves-packaged-in-1lb-5lb-22-25lb-clear-plastic-units-no-u/"}, {"id": "fda-food-h-0143-2027", "source": "FDA", "category": "food", "recall_number": "H-0143-2027", "title": "Walnuts in Shell recall (El Ruisenor De Mexico, Inc.)", "product": "Walnuts in Shell; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Walnuts)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "155.63 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0143-2027%22", "url": "https://recallledger.net/recalls/food-h-0143-2027-walnuts-in-shell-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-u/"}, {"id": "fda-food-h-0142-2027", "source": "FDA", "category": "food", "recall_number": "H-0142-2027", "title": "Homestyle Poblano Mole recall (El Ruisenor De Mexico, Inc.)", "product": "Homestyle Poblano Mole; packaged in 1lb, 5lb, 22lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Sulfites)", "hazard_level": "Class I", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "844pounds", "codes": "Lot: 3032026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0142-2027%22", "url": "https://recallledger.net/recalls/food-h-0142-2027-homestyle-poblano-mole-packaged-in-1lb-5lb-22lb-clear-plastic-units/"}, {"id": "fda-food-h-0141-2027", "source": "FDA", "category": "food", "recall_number": "H-0141-2027", "title": "Special Red Almond Mole Powder recall (El Ruisenor De Mexico, Inc.)", "product": "Special Red Almond Mole Powder; packaged in 1lb, 5lb, 11lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2)", "hazard_level": "Class I", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1,277.91 pounds", "codes": "Lot: 14250", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0141-2027%22", "url": "https://recallledger.net/recalls/food-h-0141-2027-special-red-almond-mole-powder-packaged-in-1lb-5lb-11lb-clear-plast/"}, {"id": "fda-food-h-0140-2027", "source": "FDA", "category": "food", "recall_number": "H-0140-2027", "title": "Roasted & Salted Mixed Nuts recall (El Ruisenor De Mexico, Inc.)", "product": "Roasted & Salted Mixed Nuts; packaged in 1lb, 5lb, 25lb clear plastic units.  Roasted & Unsalted Mixed Nuts; packaged in 1lb, 5lb, 25lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Cashew, Almond, Brazil Nut, Hazelnut, Pecan)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "82.1 pounds across both items", "codes": "Unsalted Lot Code: 690-035 Salted Lot code: none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0140-2027%22", "url": "https://recallledger.net/recalls/food-h-0140-2027-roasted-salted-mixed-nuts-packaged-in-1lb-5lb-25lb-clear-plastic/"}, {"id": "fda-food-h-0139-2027", "source": "FDA", "category": "food", "recall_number": "H-0139-2027", "title": "Air-Dried Apple Rings recall (El Ruisenor De Mexico, Inc.)", "product": "Air-Dried Apple Rings; packaged in 1lb, 5lb, 22lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "21.20 pounds", "codes": "lot: 1400/08067-25098-1", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0139-2027%22", "url": "https://recallledger.net/recalls/food-h-0139-2027-air-dried-apple-rings-packaged-in-1lb-5lb-22lb-clear-plastic-units/"}, {"id": "fda-food-h-0138-2027", "source": "FDA", "category": "food", "recall_number": "H-0138-2027", "title": "Dried Mango Slices recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Mango Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites, Yellow#6)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2,935 pounds", "codes": "lot: 14944", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0138-2027%22", "url": "https://recallledger.net/recalls/food-h-0138-2027-dried-mango-slices-packaged-in-1lb-5lb-44lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0137-2027", "source": "FDA", "category": "food", "recall_number": "H-0137-2027", "title": "Dried Kiwi Slices recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Kiwi Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Sulfites, Yellow#5, Blue#1)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "217 pounds", "codes": "lot: KW-R01-44", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0137-2027%22", "url": "https://recallledger.net/recalls/food-h-0137-2027-dried-kiwi-slices-packaged-in-1lb-5lb-44lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0136-2027", "source": "FDA", "category": "food", "recall_number": "H-0136-2027", "title": "Horchata Drink Mix recall (El Ruisenor De Mexico, Inc.)", "product": "Horchata Drink Mix; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Milk)", "hazard_level": "Class I", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "4, 028 pounds", "codes": "lot: 3260420701", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0136-2027%22", "url": "https://recallledger.net/recalls/food-h-0136-2027-horchata-drink-mix-packaged-in-1lb-5lb-50lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0135-2027", "source": "FDA", "category": "food", "recall_number": "H-0135-2027", "title": "Honey Nut Granola recall (El Ruisenor De Mexico, Inc.)", "product": "Honey Nut Granola", "reason": "undeclared allergen ingredient (Almond, Cashew)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "unknown", "codes": "TBD", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0135-2027%22", "url": "https://recallledger.net/recalls/food-h-0135-2027-honey-nut-granola/"}, {"id": "fda-food-h-0134-2027", "source": "FDA", "category": "food", "recall_number": "H-0134-2027", "title": "Harina de Trigo recall (El Ruisenor De Mexico, Inc.)", "product": "Harina de Trigo; Whole Wheat Flour; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2231 pounds", "codes": "lot: 124624", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0134-2027%22", "url": "https://recallledger.net/recalls/food-h-0134-2027-harina-de-trigo-whole-wheat-flour-packed-in-a-clear-plastic-bag-1lb/"}, {"id": "fda-food-h-0133-2027", "source": "FDA", "category": "food", "recall_number": "H-0133-2027", "title": "Almond Flour recall (El Ruisenor De Mexico, Inc.)", "product": "Almond Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Almond)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "6 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0133-2027%22", "url": "https://recallledger.net/recalls/food-h-0133-2027-almond-flour-packaged-in-1lb-5lb-50lb-clear-plastic-units-no-upc/"}, {"id": "fda-food-h-0132-2027", "source": "FDA", "category": "food", "recall_number": "H-0132-2027", "title": "All-Purpose Flour recall (El Ruisenor De Mexico, Inc.)", "product": "All-Purpose Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "300 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0132-2027%22", "url": "https://recallledger.net/recalls/food-h-0132-2027-all-purpose-flour-packaged-in-1lb-5lb-50lb-clear-plastic-units-no/"}, {"id": "fda-food-h-0131-2027", "source": "FDA", "category": "food", "recall_number": "H-0131-2027", "title": "Jovy Gummy Worms recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Gummy Worms (Regular); packaged in 1lb plastic units. UPC: 712199083398", "reason": "undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "327 pounds", "codes": "lot: 6087", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0131-2027%22", "url": "https://recallledger.net/recalls/food-h-0131-2027-jovy-gummy-worms-regular-packaged-in-1lb-plastic-units-upc-712199/"}, {"id": "fda-food-h-0130-2027", "source": "FDA", "category": "food", "recall_number": "H-0130-2027", "title": "Jovy Gummy Worms Neon recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Gummy Worms Neon; packaged in 1lb plastic units. UPC 712199083411", "reason": "undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "521 pounds", "codes": "lot: 6156", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0130-2027%22", "url": "https://recallledger.net/recalls/food-h-0130-2027-jovy-gummy-worms-neon-packaged-in-1lb-plastic-units-upc-712199083411/"}, {"id": "fda-food-h-0129-2027", "source": "FDA", "category": "food", "recall_number": "H-0129-2027", "title": "Jovy Gummy Bears Regular recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Gummy Bears Regular; packed in a clear plastic 1lb unit sizes. UPC: UPC 712199085156", "reason": "undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "516 pounds", "codes": "Lot: 6155", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0129-2027%22", "url": "https://recallledger.net/recalls/food-h-0129-2027-jovy-gummy-bears-regular-packed-in-a-clear-plastic-1lb-unit-sizes-up/"}, {"id": "fda-food-h-0128-2027", "source": "FDA", "category": "food", "recall_number": "H-0128-2027", "title": "Jovy Gummy Bears Neon recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Gummy Bears Neon; packed in 1lb plastic units. UPC 712199083558", "reason": "undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "127 pounds", "codes": "Lot: 5120", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0128-2027%22", "url": "https://recallledger.net/recalls/food-h-0128-2027-jovy-gummy-bears-neon-packed-in-1lb-plastic-units-upc-712199083558/"}, {"id": "fda-food-h-0127-2027", "source": "FDA", "category": "food", "recall_number": "H-0127-2027", "title": "Jovy Watermelon Gummy Rings recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Watermelon Gummy Rings; packed in a clear plastic 1lb unit sizes. UPC 712199083510", "reason": "undeclared allergen ingredient (Red#40)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1,395 pounds", "codes": "Lot: 6101", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0127-2027%22", "url": "https://recallledger.net/recalls/food-h-0127-2027-jovy-watermelon-gummy-rings-packed-in-a-clear-plastic-1lb-unit-sizes/"}, {"id": "fda-food-h-0126-2027", "source": "FDA", "category": "food", "recall_number": "H-0126-2027", "title": "Apple Rings recall (El Ruisenor De Mexico, Inc.)", "product": "Apple Rings; packed in 1lb, 5lb, and 2lb unit sizes. Product code: APLC-R01-22", "reason": "undeclared sulfites", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "21.20 pounds", "codes": "lot: 1400/08067-25098-1", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0126-2027%22", "url": "https://recallledger.net/recalls/food-h-0126-2027-apple-rings-packed-in-1lb-5lb-and-2lb-unit-sizes-product-code-apl/"}, {"id": "fda-food-h-0125-2027", "source": "FDA", "category": "food", "recall_number": "H-0125-2027", "title": "Jovy Gummy Peach Rings recall (El Ruisenor De Mexico, Inc.)", "product": "Jovy Gummy Peach Rings; packed in a clear plastic 1lb unit sizes. UPC: 712199083404", "reason": "undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "687 pounds", "codes": "lot: 6124", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0125-2027%22", "url": "https://recallledger.net/recalls/food-h-0125-2027-jovy-gummy-peach-rings-packed-in-a-clear-plastic-1lb-unit-sizes-upc/"}, {"id": "fda-food-h-0124-2027", "source": "FDA", "category": "food", "recall_number": "H-0124-2027", "title": "Dried Fruit Mix recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Fruit Mix; packed in a clear plastic 1lb, 5lb, 25lb unit sizes.", "reason": "undeclared allergen ingredient (Sulfites, Yellow#6)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "903.71 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0124-2027%22", "url": "https://recallledger.net/recalls/food-h-0124-2027-dried-fruit-mix-packed-in-a-clear-plastic-1lb-5lb-25lb-unit-sizes/"}, {"id": "fda-food-h-0123-2027", "source": "FDA", "category": "food", "recall_number": "H-0123-2027", "title": "Fritura Rueda Papa / Potato Wheel Snack recall (El Ruisenor De Mexico, Inc.)", "product": "Fritura Rueda Papa / Potato Wheel Snack; packed in a clear plastic 1lb, 5lb, 33lb unit sizes. No UPC", "reason": "undeclared allergen ingredient (Wheat)", "hazard_level": "Class I", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "260.16 pounds", "codes": "lot code: 069 2 26 1 020", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0123-2027%22", "url": "https://recallledger.net/recalls/food-h-0123-2027-fritura-rueda-papa-potato-wheel-snack-packed-in-a-clear-plastic-1lb/"}, {"id": "fda-food-h-0122-2027", "source": "FDA", "category": "food", "recall_number": "H-0122-2027", "title": "Fritura Rueda / Wheat Wheel Snack recall (El Ruisenor De Mexico, Inc.)", "product": "Fritura Rueda / Wheat Wheel Snack; packed in a clear plastic 2lb, 5lb, 33lb unit sizes. no UPC", "reason": "undeclared allergen ingredient (Wheat, Yellow#5, Yellow #6,)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1774 pounds", "codes": "lot code: 1493261035", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0122-2027%22", "url": "https://recallledger.net/recalls/food-h-0122-2027-fritura-rueda-wheat-wheel-snack-packed-in-a-clear-plastic-2lb-5lb/"}, {"id": "fda-food-h-0121-2027", "source": "FDA", "category": "food", "recall_number": "H-0121-2027", "title": "Fritura Lagrimita / Teardrop Wheat Snack recall (El Ruisenor De Mexico, Inc.)", "product": "Fritura Lagrimita / Teardrop Wheat Snack; packed in a clear plastic 1lb, 5lb, 44lb unit sizes.", "reason": "undeclared allergen ingredient (Wheat, Yellow #6, Soy)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1078 pounds", "codes": "lot: 261705", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0121-2027%22", "url": "https://recallledger.net/recalls/food-h-0121-2027-fritura-lagrimita-teardrop-wheat-snack-packed-in-a-clear-plastic-1l/"}, {"id": "fda-food-h-0120-2027", "source": "FDA", "category": "food", "recall_number": "H-0120-2027", "title": "Fritura mixed dry fruit recall (El Ruisenor De Mexico, Inc.)", "product": "Fritura mixed dry fruit; packed in a clear plastic 1lb, 5lb, 25lb unit sizes. no UPC", "reason": "undeclared allergen ingredient (Wheat, Yellow #5, Yellow #6)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "134.59 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0120-2027%22", "url": "https://recallledger.net/recalls/food-h-0120-2027-fritura-mixed-dry-fruit-packed-in-a-clear-plastic-1lb-5lb-25lb-unit/"}, {"id": "fda-food-h-0119-2027", "source": "FDA", "category": "food", "recall_number": "H-0119-2027", "title": "Soybeans recall (El Ruisenor De Mexico, Inc.)", "product": "Soybeans; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. No UPC", "reason": "undeclared allergen ingredient (Soy)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "5 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0119-2027%22", "url": "https://recallledger.net/recalls/food-h-0119-2027-soybeans-packed-in-a-clear-plastic-1lb-5lb-50lb-unit-sizes-no-upc/"}, {"id": "fda-food-h-0118-2027", "source": "FDA", "category": "food", "recall_number": "H-0118-2027", "title": "Dried Peaches recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Peaches; packed in a clear plastic 1lb, 5lb, 22-25lb unit sizes. No UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "29 pounds", "codes": "none", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0118-2027%22", "url": "https://recallledger.net/recalls/food-h-0118-2027-dried-peaches-packed-in-a-clear-plastic-1lb-5lb-22-25lb-unit-sizes/"}, {"id": "fda-food-h-0117-2027", "source": "FDA", "category": "food", "recall_number": "H-0117-2027", "title": "Churro Mix recall (El Ruisenor De Mexico, Inc.)", "product": "Churro Mix; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. no UPC", "reason": "undeclared allergen ingredient (Egg, Wheat)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "214 pounds", "codes": "lot code: 3263290501", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0117-2027%22", "url": "https://recallledger.net/recalls/food-h-0117-2027-churro-mix-packed-in-a-clear-plastic-1lb-5lb-50lb-unit-sizes-no-up/"}, {"id": "fda-food-h-0116-2027", "source": "FDA", "category": "food", "recall_number": "H-0116-2027", "title": "Whole Pitted Dried Apricots recall (El Ruisenor De Mexico, Inc.)", "product": "Whole Pitted Dried Apricots; packed in a clear plastic 1lb, 5lb, 28lb unit sizes. no UPC", "reason": "undeclared allergen ingredient (Sulfites)", "hazard_level": "Class II", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "102 pounds", "codes": "lot code: 440024553-11-001", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0116-2027%22", "url": "https://recallledger.net/recalls/food-h-0116-2027-whole-pitted-dried-apricots-packed-in-a-clear-plastic-1lb-5lb-28lb/"}, {"id": "fda-food-h-0115-2027", "source": "FDA", "category": "food", "recall_number": "H-0115-2027", "title": "Ground Shrimp recall (El Ruisenor De Mexico, Inc.)", "product": "Ground Shrimp; packed in a clear plastic 1lb, 5lb, 25-50lb unit sizes. No UPC", "reason": "undeclared allergen ingredient (shrimp)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "263.52 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0115-2027%22", "url": "https://recallledger.net/recalls/food-h-0115-2027-ground-shrimp-packed-in-a-clear-plastic-1lb-5lb-25-50lb-unit-sizes/"}, {"id": "fda-food-h-0114-2027", "source": "FDA", "category": "food", "recall_number": "H-0114-2027", "title": "Dried Whole Shrimp recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Whole Shrimp; packed in a clear plastic 1lb, 5lb, 30lb unit sizes. No UPC", "reason": "undeclared allergen ingredient (shrimp)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "192 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0114-2027%22", "url": "https://recallledger.net/recalls/food-h-0114-2027-dried-whole-shrimp-packed-in-a-clear-plastic-1lb-5lb-30lb-unit-size/"}, {"id": "fda-food-h-0113-2027", "source": "FDA", "category": "food", "recall_number": "H-0113-2027", "title": "Raw In-Shell Peanuts recall (El Ruisenor De Mexico, Inc.)", "product": "Raw In-Shell Peanuts; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. Raw Spanish Peanuts; sold by weight (bulk) Raw shelled Peanuts; packed in a clear plastic 1lb, 5lb, 25lb unit sizes Roasted Peanuts; packed in a clear plastic 1lb, 5lb, 25lb unit sizes packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Peanuts)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "1,849 pounds across all items", "codes": "Lot codes: Raw In-Shell Peanuts; 12545 Raw Spanish Peanuts; none Raw shelled Peanuts; none Roasted Peanuts; 340-100", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0113-2027%22", "url": "https://recallledger.net/recalls/food-h-0113-2027-raw-in-shell-peanuts-packed-in-a-clear-plastic-1lb-5lb-50lb-unit-si/"}, {"id": "fda-food-h-0112-2027", "source": "FDA", "category": "food", "recall_number": "H-0112-2027", "title": "Butter Toffee Peanuts recall (El Ruisenor De Mexico, Inc.)", "product": "Butter Toffee Peanuts; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Peanuts, Milk)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "241 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0112-2027%22", "url": "https://recallledger.net/recalls/food-h-0112-2027-butter-toffee-peanuts-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-u/"}, {"id": "fda-food-h-0111-2027", "source": "FDA", "category": "food", "recall_number": "H-0111-2027", "title": "Dried Cod recall (El Ruisenor De Mexico, Inc.)", "product": "Dried Cod; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Fish)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "102 pounds", "codes": "lot: 440024553-11-001", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0111-2027%22", "url": "https://recallledger.net/recalls/food-h-0111-2027-dried-cod-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-unit-size-no/"}, {"id": "fda-food-h-0110-2027", "source": "FDA", "category": "food", "recall_number": "H-0110-2027", "title": "Hazelnuts in Shell recall (El Ruisenor De Mexico, Inc.)", "product": "Hazelnuts in Shell; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Hazelnut)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "20 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0110-2027%22", "url": "https://recallledger.net/recalls/food-h-0110-2027-hazelnuts-in-shell-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-unit/"}, {"id": "fda-food-h-0109-2027", "source": "FDA", "category": "food", "recall_number": "H-0109-2027", "title": "Sliced Almonds recall (El Ruisenor De Mexico, Inc.)", "product": "Sliced Almonds; packed in a clear plastic bag. 1lb, 5lb, 25lb unit size. No UPC", "reason": "undeclared allergen ingredient (Almond)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "411 pounds", "codes": "lot: 181759P", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0109-2027%22", "url": "https://recallledger.net/recalls/food-h-0109-2027-sliced-almonds-packed-in-a-clear-plastic-bag-1lb-5lb-25lb-unit-siz/"}, {"id": "fda-food-h-0108-2027", "source": "FDA", "category": "food", "recall_number": "H-0108-2027", "title": "Roasted Whole Almonds recall (El Ruisenor De Mexico, Inc.)", "product": "Roasted Whole Almonds; packed in a clear plastic bag. 1lb, 5lb, 25lb unit size. No UPC", "reason": "undeclared allergen ingredient (Almond)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "105.93 pounds", "codes": "no lot code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0108-2027%22", "url": "https://recallledger.net/recalls/food-h-0108-2027-roasted-whole-almonds-packed-in-a-clear-plastic-bag-1lb-5lb-25lb-u/"}, {"id": "fda-food-h-0107-2027", "source": "FDA", "category": "food", "recall_number": "H-0107-2027", "title": "Chocolate Covered Almonds recall (El Ruisenor De Mexico, Inc.)", "product": "Chocolate Covered Almonds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Almond)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "24.5 pounds", "codes": "lot: 630-035", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0107-2027%22", "url": "https://recallledger.net/recalls/food-h-0107-2027-chocolate-covered-almonds-packed-in-a-clear-plastic-bag-1lb-5lb-50/"}, {"id": "fda-food-h-0106-2027", "source": "FDA", "category": "food", "recall_number": "H-0106-2027", "title": "Almonds in Shell recall (El Ruisenor De Mexico, Inc.)", "product": "Almonds in Shell; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Almond)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2 pounds", "codes": "no lot number", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0106-2027%22", "url": "https://recallledger.net/recalls/food-h-0106-2027-almonds-in-shell-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-unit-s/"}, {"id": "fda-food-h-0105-2027", "source": "FDA", "category": "food", "recall_number": "H-0105-2027", "title": "Hulled Sesame Seeds recall (El Ruisenor De Mexico, Inc.)", "product": "Hulled Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Sesame)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2783 pounds", "codes": "lot: 101026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0105-2027%22", "url": "https://recallledger.net/recalls/food-h-0105-2027-hulled-sesame-seeds-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-uni/"}, {"id": "fda-food-h-0104-2027", "source": "FDA", "category": "food", "recall_number": "H-0104-2027", "title": "Black Sesame Seeds recall (El Ruisenor De Mexico, Inc.)", "product": "Black Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "undeclared allergen ingredient (Sesame)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "156.97 pounds", "codes": "lot: 10989", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0104-2027%22", "url": "https://recallledger.net/recalls/food-h-0104-2027-black-sesame-seeds-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-unit/"}, {"id": "fda-food-h-0103-2027", "source": "FDA", "category": "food", "recall_number": "H-0103-2027", "title": "Natural Sesame Seeds recall (El Ruisenor De Mexico, Inc.)", "product": "Natural Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC", "reason": "various undeclared allergen ingredients (Sesame)", "hazard_level": "Class III", "company": "El Ruisenor De Mexico, Inc.", "company_location": "Vernon, CA, United States", "date": "2026-08-24", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "Recalling firm distributes primarily to California customers both retail and wholesale. Additional distribution to limited customers in Hawaii, Illinois, Kansas, Nevada, Oregon, and Washington.", "states": ["CA", "HI", "IL", "KS", "NV", "OR", "WA"], "nationwide": false, "quantity": "2783 pounds", "codes": "lot: 101026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0103-2027%22", "url": "https://recallledger.net/recalls/food-h-0103-2027-natural-sesame-seeds-packed-in-a-clear-plastic-bag-1lb-5lb-50lb-un/"}, {"id": "fda-device-z-0211-2027", "source": "FDA", "category": "device", "recall_number": "Z-0211-2027", "title": "Ion Torrent Genexus Dx with software recall (Life Technologies Holdings Pte Ltd)", "product": "Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer", "reason": "DNA or RNA sequencing system software has vulnerabilities.", "hazard_level": "Class II", "company": "Life Technologies Holdings Pte Ltd", "company_location": "Singapore, Singapore", "date": "2026-08-14", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ, MA, LA, OK.", "states": ["AZ", "CA", "CO", "KY", "LA", "MA", "NC", "NY", "OK", "PA"], "nationwide": true, "quantity": "16", "codes": "UDI-DI: 10190302018883, Software: 6.8.2.1 and earlier. Sequencer UDI-DI: 10190302017794. Sequencer Serial Numbers:  2619124040913, 2619726010247, 2619124060941, 2619124060942, 2619725090229,  2619725100238, 2619122070666,  2619725080220, 2619725090226, 2619726010251, 2619726020265, 2619725090225, 2619725100235, 2619725050205, 2619726010249, 2619122070658", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2027%22", "url": "https://recallledger.net/recalls/device-z-0211-2027-ion-torrent-genexus-dx-with-software-catalog-a40003539-which-suppor/"}, {"id": "fda-device-z-0207-2027", "source": "FDA", "category": "device", "recall_number": "Z-0207-2027", "title": "Techno-Path Multichem AE Unassayed Level 3 recall (TECHNO-PATH MANUFACTURING LTD.)", "product": "Techno-Path Multichem AE Unassayed Level 3, REF:AE623X", "reason": "A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.", "hazard_level": "Class II", "company": "TECHNO-PATH MANUFACTURING LTD.", "company_location": "Ballina Tipperary, Ireland", "date": "2026-08-14", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of Massachusetts.", "states": ["MA"], "nationwide": true, "quantity": "832 units", "codes": "UDI:(01)05391523442824/-Lot # 65705263", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0207-2027%22", "url": "https://recallledger.net/recalls/device-z-0207-2027-techno-path-multichem-ae-unassayed-level-3-ref-ae623x/"}, {"id": "fda-device-z-0206-2027", "source": "FDA", "category": "device", "recall_number": "Z-0206-2027", "title": "Techno-Path Multichem AE Unassayed Level 2  REF: AE622X recall (TECHNO-PATH MANUFACTURING LTD.)", "product": "Techno-Path Multichem AE Unassayed Level 2  REF: AE622X", "reason": "A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.", "hazard_level": "Class II", "company": "TECHNO-PATH MANUFACTURING LTD.", "company_location": "Ballina Tipperary, Ireland", "date": "2026-08-14", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of Massachusetts.", "states": ["MA"], "nationwide": true, "quantity": "123 units", "codes": "UDI:(01)05391523442817/Lot # 65705262", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2027%22", "url": "https://recallledger.net/recalls/device-z-0206-2027-techno-path-multichem-ae-unassayed-level-2-ref-ae622x/"}, {"id": "fda-device-z-0205-2027", "source": "FDA", "category": "device", "recall_number": "Z-0205-2027", "title": "Techno-Path  Multichem AE Unassayed Level 1  REF:AE621X recall (TECHNO-PATH MANUFACTURING LTD.)", "product": "Techno-Path  Multichem AE Unassayed Level 1  REF:AE621X", "reason": "A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only.     The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.", "hazard_level": "Class II", "company": "TECHNO-PATH MANUFACTURING LTD.", "company_location": "Ballina Tipperary, Ireland", "date": "2026-08-14", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of Massachusetts.", "states": ["MA"], "nationwide": true, "quantity": "832 units", "codes": "UDI: (01)05391523442800/Lot # 65705261", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0205-2027%22", "url": "https://recallledger.net/recalls/device-z-0205-2027-techno-path-multichem-ae-unassayed-level-1-ref-ae621x/"}, {"id": "fda-device-z-0197-2027", "source": "FDA", "category": "device", "recall_number": "Z-0197-2027", "title": "Medtronic Biopsy Needle Kit recall (Medtronic Navigation, Inc.)", "product": "Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO,  Rxonly", "reason": "Sterile Passive spheres and biopsy needle kits contain variation in the reflective material  which may affect the ability of the navigation system to detect and track the spheres.", "hazard_level": "Class II", "company": "Medtronic Navigation, Inc.", "company_location": "Lafayette, CO, United States", "date": "2026-08-31", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tKY    \tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY\t OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "3746 units", "codes": "UDI: 00643169702943/ Lots: 066500526 066501226 066503326 066504726 066506326 066509826;  UDI:00643169030121/Lots:  066500526 066506326", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2027%22", "url": "https://recallledger.net/recalls/device-z-0197-2027-medtronic-biopsy-needle-kit-ref-9733068-passive-sterile-eo-rxonl/"}, {"id": "fda-device-z-0196-2027", "source": "FDA", "category": "device", "recall_number": "Z-0196-2027", "title": "Medtronic NDI Passive Spheres  REF: 8801075 recall (Medtronic Navigation, Inc.)", "product": "Medtronic NDI Passive Spheres  REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly", "reason": "Sterile Passive spheres and biopsy needle kits contain variation in the reflective material  which may affect the ability of the navigation system to detect and track the spheres.", "hazard_level": "Class II", "company": "Medtronic Navigation, Inc.", "company_location": "Lafayette, CO, United States", "date": "2026-08-31", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tKY    \tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY\t OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "476,256 units", "codes": "UDI: 00643169278028/ Lots: 2503291 2503331 2503381 2504011 2504021 2504151 2504361 2505101 2505111 2505231 2505291 2505411 2505491 2505661 2506101 2506181 2506401 2506431 2506491 2506501 2509551 2509561 2509831 2510011 2510031 2510171 2510181 2510221 2510241 2510561 2510611 2510771 2510781 2511261 2511521 2511621 2511631 2512091;  UDI: 20805832070030/ Lots: 2502431 2512091 2502431 2502461 2502511 2502531 2502541 2503071 2503081 2503091 2503101 2503111 2503121 2503161 2503171 2503181 2503191 2503201 2503211 2503221 2503251 2503261 2503271 2503281 2503291 2503331 2503341 2503351 2503361 2503381 2503401 2504011 2504021 2504041 2504051 2504071 2504101 2504151 2504201 2504281 2504341 2504351 2504361 2504371 2505101 2505111 2505121 2505141 2505161 2505231 2505241 2505251 2505261 2505281 2505291 2505301 2505311 2505361 2505401 2505411 2505491 2505501 2505511 2505601 2505621 2505631 2505661 2506091 2506101 2506111 2506121 2506141 2506151 2506171 2506181 2506191 2506201 2506211 2506261 2506271 2506281 2506351 2506361 2506381 2506401 2506421 2506431 2506461 2506471 2506481 2506491 2506501 2506521 2506531 2506591 2506641 2507081 2507091 2509421 2509431 2509531 2509551 2509561 2509581 2509591 2509601 2509611 2509731 2509741 2509751 2509761 2509771 2509821 2509831 2509841 2510011 2510021 2510031 2510041 2510051 2510061 2510071 2510081 2510091 2510101 2510131 2510141 2510151 2510171 2510181 2510191 2510221 2510231 2510241 2510291 2510531 2510541 2510561 2510571 2510611 2510761 2510771 2510781 2510791 2510801 2510811 2511061 2511071 2511081 2511131 2511141 2511171 2511181 2511191 2511201 2511211 2511251 2511261 2511271 2511281 2511301 2511311 2511321 2511511 2511521 2511531 2511631 2512091 2510351 2510381", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2027%22", "url": "https://recallledger.net/recalls/device-z-0196-2027-medtronic-ndi-passive-spheres-ref-8801075-sterile-eo-5-tray-12-pk/"}, {"id": "fda-device-z-0195-2027", "source": "FDA", "category": "device", "recall_number": "Z-0195-2027", "title": "Medtronic NDI Passive Spheres  REF: 8801074 recall (Medtronic Navigation, Inc.)", "product": "Medtronic NDI Passive Spheres  REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly", "reason": "Sterile Passive spheres and biopsy needle kits contain variation in the reflective material  which may affect the ability of the navigation system to detect and track the spheres.", "hazard_level": "Class II", "company": "Medtronic Navigation, Inc.", "company_location": "Lafayette, CO, United States", "date": "2026-08-31", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tKY    \tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY\t OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "83,594 units", "codes": "UDI: 20805832070023/ Lot codes: 2503141 2503241 2503411 2503491 2504081 2504091 2504211 2504301 2504331 2505211 2505221 2505351 2505641 2505651 2505681 2506081 2506161 2506341 2506551 2506581 2509781 2509791 2509811 2510121 2510741 2510751 2511101 2511121 2511501 2511601", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0195-2027%22", "url": "https://recallledger.net/recalls/device-z-0195-2027-medtronic-ndi-passive-spheres-ref-8801074-sterile-eo-4-tray-12-pk/"}, {"id": "fda-device-z-0194-2027", "source": "FDA", "category": "device", "recall_number": "Z-0194-2027", "title": "Medtronic NDI Passive Spheres  REF: 8801071 recall (Medtronic Navigation, Inc.)", "product": "Medtronic NDI Passive Spheres  REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly", "reason": "Sterile Passive spheres and biopsy needle kits contain variation in the reflective material  which may affect the ability of the navigation system to detect and track the spheres.", "hazard_level": "Class II", "company": "Medtronic Navigation, Inc.", "company_location": "Lafayette, CO, United States", "date": "2026-08-31", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tKY    \tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY\t OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "14210 units", "codes": "UDI: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0194-2027%22", "url": "https://recallledger.net/recalls/device-z-0194-2027-medtronic-ndi-passive-spheres-ref-8801071-sterile-eo-1-tray-12-pk/"}, {"id": "fda-device-z-0192-2027", "source": "FDA", "category": "device", "recall_number": "Z-0192-2027", "title": "Think Surgical Square Driver  REF: 109126 recall (Think Surgical, Inc.)", "product": "Think Surgical Square Driver  REF: 109126", "reason": "Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.", "hazard_level": "Class II", "company": "Think Surgical, Inc.", "company_location": "Fremont, CA, United States", "date": "2026-08-20", "report_date": "2026-10-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of NY and DE.", "states": ["DE", "NY"], "nationwide": true, "quantity": "15 units", "codes": "Lot: 25356/Primary DI: M9461091260", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2027%22", "url": "https://recallledger.net/recalls/device-z-0192-2027-think-surgical-square-driver-ref-109126/"}, {"id": "fda-device-z-0190-2027", "source": "FDA", "category": "device", "recall_number": "Z-0190-2027", "title": "The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists recall (Radiometer Medical ApS)", "product": "The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.", "reason": "In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.", "hazard_level": "Class II", "company": "Radiometer Medical ApS", "company_location": "Bronshoj, Denmark", "date": "2026-08-18", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "5395", "codes": "UDI-DI: 05700693930923, 05700693930909 Software versions 3.6 and lower. ABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O.   ABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0190-2027%22", "url": "https://recallledger.net/recalls/device-z-0190-2027-the-abl90-flex-and-abl90-flex-plus-analyzers-are-intended-for-use-by-t/"}, {"id": "fda-device-z-0187-2027", "source": "FDA", "category": "device", "recall_number": "Z-0187-2027", "title": "Scout MD recall (Merit Medical Systems, Inc.)", "product": "Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01   Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO", "reason": "The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2026-08-27", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US: AZ, CA, FL, IN, LA,  NV, RI OUS: None", "states": ["AZ", "CA", "FL", "IN", "LA", "NV", "RI"], "nationwide": false, "quantity": "", "codes": "MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2027%22", "url": "https://recallledger.net/recalls/device-z-0187-2027-scout-md-ref-mds05a-01-mds05c-01-mds10c-01-contents-1-scout-md/"}, {"id": "fda-device-z-0185-2027", "source": "FDA", "category": "device", "recall_number": "Z-0185-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    KIT ROBOTICS UROLOGY... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116G", "reason": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.", "states": ["AZ", "CA", "IN", "MD", "MO", "NJ", "OH", "WI"], "nationwide": true, "quantity": "3,551 kits", "codes": "DYKMBNDL116G    UDI-DI 10198459156991    Lots 24KBD429   24LBE008   24LBH410   25ABF361   25BBI842   25EBM426   25GBG086   25JBF391   25KBA114   25KBN017   25LBQ601", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0185-2027%22", "url": "https://recallledger.net/recalls/device-z-0185-2027-convenience-kits-containing-conmed-airseal-access-ports-kit-robotic/"}, {"id": "fda-device-z-0184-2027", "source": "FDA", "category": "device", "recall_number": "Z-0184-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    ADVANCE LAPAROSCOPIC\t ... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    ADVANCE LAPAROSCOPIC\t  \tDYNJ911135A  \t  CHN GYN ONCOLOGY\t  \tDYNJ906731M", "reason": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.", "states": ["AZ", "CA", "IN", "MD", "MO", "NJ", "OH", "WI"], "nationwide": true, "quantity": "3,551 kits", "codes": "DYNJ911135A    UDI-DI 10198459655623    Lot 26EDA606    DYNJ906731M    UDI-DI 10198459567117    Lots 25KDA658   25KDB571   25LDB411   26CDA536", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2027%22", "url": "https://recallledger.net/recalls/device-z-0184-2027-convenience-kits-containing-conmed-airseal-access-ports-advance-lap/"}, {"id": "fda-device-z-0183-2027", "source": "FDA", "category": "device", "recall_number": "Z-0183-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    CHN GYN ONCOLOGY\t ... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    CHN GYN ONCOLOGY\t  \tDYNJ906731K          DYNJ906731L  \tDYNJ906731N  \t  DAVINCI PROSTATECTOMY\t  \tDYNJG901002A  \t  \t  \tDYNJG901002B          DYNJG901002C  \tDYNJG901002D    GENERAL DAVINCI\t  \tDYNJG901004B  \tDYNJG901004D    HERNANDEZ DAVINCI ACC BUNDLE M\t  \tDYNJ911258A  \t  KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116D  \tDYKMBNDL116F  \t  ROBOTIC GYN\t  \tDYNJ907827F  \t  ROBOTIC PACK\t  \tDYNJ50474G    RR-DAVINCI PROSTATE ACCESSORY\t  \tDYNJ63392C          DYNJ63392F", "reason": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.", "states": ["AZ", "CA", "IN", "MD", "MO", "NJ", "OH", "WI"], "nationwide": true, "quantity": "3,551 kits", "codes": "DYNJ906731K    UDI-DI 10195327436346    Lots 24ADB566   24CDB291   24CDB969   24GDB449   24JDA590   24KDB303   25BDB494   25CDA446   25EDB457   25FDA837   25FDB582   25GDA082  DYNJ906731L    UDI-DI 10198459403675    Lots 25HDB211   25JDA226  DYNJ906731N    UDI-DI 10198459758249    Lots 26EDA043   26FDB001   26FDB487    DYNJG901002A    UDI-DI 10195327401481    Lot 24BLA300  DYNJG901002B    UDI-DI 10195327677145    Lots 24GLA290   24ILA519   24JLA479   24LLA939   25ALA154   25ELA210   25FLA112   25GLA399   25HLA560  DYNJG901002C    UDI-DI 10198459545672    Lots 25JLA619   25KLA897   26ALA207   26BLA625   26CLA984  DYNJG901002D    UDI-DI 10198459723742    Lots 26ELA161   26ELA744   26GLA765   26HLA179    DYNJG901004B    UDI-DI 10195327677138    Lots 24FLA735   24GLA836   24KLA502   25ALA409   25ALA837   25DLA322   25ELA451   25FLA291   25GLB051   25HLA207   25ILA840   25JLA027   25JLA621  DYNJG901004D    UDI-DI 10198459723759    Lots 26DLA382   26ELA743   26FLB123    DYNJ911258A    UDI-DI 10198459582097    Lot 26AMF842    DYKMBNDL116D    UDI-DI 10195327608866    Lots 24CBF889   24DBA349  DYKMBNDL116F    UDI-DI 10198459000706    Lots 24DBS388   24FBC411   24GBK948   24IBV184   24JBB328    DYNJ907827F    UDI-DI 10195327345365    Lots 24ABV361   24CBM651   24DBD866   24GBH678    DYNJ50474G    UDI-DI 10198459140235    Lots 24KDA630   25ADB023   25BDB826   25CDB231   25DDA066   25HDA254   25JDA520   25LDA008   25LDC029   26DDA900   26FDA459   26FDB573    DYNJ63392C    UDI-DI 10195327634643    Lots 24BLA318   24CLA990   24ELA575   24FLA977   24HLA137   24ILA935  DYNJ63392F    UDI-DI 10198459315572    Lots 25DLA944   25ELA626   25FLA272   25GLA905   25HLA240   25HLA894   25JLA091   25KLA775   25LLA985   26ALA670   26DLB121   26FLA701", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0183-2027%22", "url": "https://recallledger.net/recalls/device-z-0183-2027-convenience-kits-containing-conmed-airseal-access-ports-chn-gyn-onc/"}, {"id": "fda-device-z-0182-2027", "source": "FDA", "category": "device", "recall_number": "Z-0182-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    GENERAL DAVINCI\t ... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    GENERAL DAVINCI\t  \tDYNJG901004C    LAP CHOLE\t  \tDYNJ88071    ROBOTIC PACK\t  \tDYNJ50474F", "reason": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.", "states": ["AZ", "CA", "IN", "MD", "MO", "NJ", "OH", "WI"], "nationwide": true, "quantity": "3,551 kits", "codes": "DYNJG901004C    UDI-DI 10198459535772    Lots 25LLA307   26BLA900    DYNJ88071    UDI-DI 10198459098512    Lots 24KMD416   24LMG268   25AMH987   25BMA076   25GMK411    DYNJ50474F    UDI-DI 10195327559007    Lots 24DDA107   24DDA469   24EDA512   24GDB884   24IDA882", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2027%22", "url": "https://recallledger.net/recalls/device-z-0182-2027-convenience-kits-containing-conmed-airseal-access-ports-general-dav/"}, {"id": "fda-device-z-0181-2027", "source": "FDA", "category": "device", "recall_number": "Z-0181-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    HERNANDEZ DAVINCI ACC... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    HERNANDEZ DAVINCI ACC BUNDLE M\t  \tDYNJ911258    KIT ROBOTICS UROLOGY PROSTATE\t  \tDYKMBNDL116I    ROBOTIC CHEST\t  \tDYNJ910997  \tDYNJ910997A  \t  RR-DAVINCI PROSTATE ACCESSORY\t  \tDYNJ63392D    UROLOGY LAPAROSCOPIC - 51638\t  \tDYNJ908720B  \t  UROLOGY ROBOT ADD ON PACK\t  \tDYNJ85189", "reason": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.", "states": ["AZ", "CA", "IN", "MD", "MO", "NJ", "OH", "WI"], "nationwide": true, "quantity": "3,551 kits", "codes": "DYNJ911258    UDI-DI 10198459306723    Lots 25DMC798   25EMD961   25FMB704   25FMB704Z   25JMG936   25JMI469    DYKMBNDL116I    UDI-DI 10198459644764    Lots 26ABL226   26BBD710   26EBC888   26EBH673    DYNJ910997    UDI-DI 10198459241987    Lots 25DMB772   25GMA914   25GMB737   25GMC286   25GMJ509   25IMB332   25IME774   25KMB190   25KMF850   25LMB486  DYNJ910997A    UDI-DI 10198459582103    Lots 25LLA437   26BLA786   26CLB107   26DLA500   26DLB085   26FLA287   26GLA058   26GLA968   26GLB068    DYNJ63392D    UDI-DI 10198459164507    Lots 25ALA298   25BLA967    DYNJ908720B    UDI-DI 10198459642517    Lots 26EBE658    DYNJ85189    UDI-DI 10195327473754    Lots 24AMA883", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2027%22", "url": "https://recallledger.net/recalls/device-z-0181-2027-convenience-kits-containing-conmed-airseal-access-ports-hernandez-d/"}, {"id": "fda-device-z-0180-2027", "source": "FDA", "category": "device", "recall_number": "Z-0180-2027", "title": "Convenience Kits containing CONMED AirSeal Access Ports    ADVANCE LAPAROSCOPIC\t ... recall (Medline Industries, LP)", "product": "Convenience Kits containing CONMED AirSeal Access Ports    ADVANCE LAPAROSCOPIC\t  \tDYNJ911135  \t  LAP CHOLE\t  \tDYNJ911660  \t  LAP NISSEN\t  \tDYNJ911560    UROLOGY LAPAROSCOPIC - 51638\t  \tDYNJ908720A", "reason": "Kits contain CONMED AirSeal Access Ports. 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When the check  valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor,  potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure),  biohazardous exposure, property damage, and delayed patient results.", "hazard_level": "Class II", "company": "Beckman Coulter, Inc.", "company_location": "Miami, FL, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "", "codes": "Product/UDI-DI:  IQ200 SPRINT/10837461001256, IQ200 SELECT/10837461001300, IQ200 ELITE/10837461001355.  All Serial Numbers", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0161-2027%22", "url": "https://recallledger.net/recalls/device-z-0161-2027-iq200-sprint-ref-700-3322-700-3322rfb-700-3325-700-3326-b48997/"}, {"id": "fda-device-z-0160-2027", "source": "FDA", "category": "device", "recall_number": "Z-0160-2027", "title": "DxU 840m Iris recall (Beckman Coulter, Inc.)", "product": "DxU 840m Iris, REF: C76947;  DxU 850m Iris, REF: C49513", "reason": "The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement  to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual  preventive maintenance (PM) requirements without adequate reliability evaluation. When the check  valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor,  potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure),  biohazardous exposure, property damage, and delayed patient results.", "hazard_level": "Class II", "company": "Beckman Coulter, Inc.", "company_location": "Miami, FL, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "2,088", "codes": "Product/UDI-DI:  DxU 840m/15099590748654, DxU 850m/15099590748647.  All Serial Numbers", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2027%22", "url": "https://recallledger.net/recalls/device-z-0160-2027-dxu-840m-iris-ref-c76947-dxu-850m-iris-ref-c49513/"}, {"id": "fda-device-z-0159-2027", "source": "FDA", "category": "device", "recall_number": "Z-0159-2027", "title": "MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control recall (Microgenics Corporation)", "product": "MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF:   OPRO-101;   MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP", "reason": "Vial-to-vial variability in MAS¿ Omni\"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.", "hazard_level": "Class II", "company": "Microgenics Corporation", "company_location": "Fremont, CA, United States", "date": "2026-08-17", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX, CA, LA, SC, OH, MO, OR and the countries of KOR, BGD, THA, ZAF, DEU, VNM, BRA, NZL.", "states": ["CA", "LA", "MI", "MO", "NY", "OH", "OK", "OR", "SC", "TX", "UT"], "nationwide": true, "quantity": "1366", "codes": "REF/UDI-DI/Lot(Expiration): OPRO-101/00884883005327/OPRO29061A(2029-06-30); OPRO-SP/00884883005358/OPRO2906SA(2029-06-30)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0159-2027%22", "url": "https://recallledger.net/recalls/device-z-0159-2027-mas-omni-immune-pro-liquid-assayed-integrated-immunoassay-control-lev/"}, {"id": "fda-device-z-0150-2027", "source": "FDA", "category": "device", "recall_number": "Z-0150-2027", "title": "Generic Name: BioFire¿ Joint Infection recall (BioFire Diagnostics, LLC)", "product": "Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A", "reason": "Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results", "hazard_level": "Class II", "company": "BioFire Diagnostics, LLC", "company_location": "Salt Lake City, UT, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "1,186", "codes": "Lot Code: UDI Nos 00815381020192 (30 Kit), 00815381020208 (6 Kit); Model Nos RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit); Lot Numbers 0677326, 0806426, 0806526, 1289126, 1289226, 1405526, 1405626, 1413026, 1413426, 1413526, 1507826, 1613326, 1684726", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0150-2027%22", "url": "https://recallledger.net/recalls/device-z-0150-2027-generic-name-biofire-joint-infection-ji-panel-generic-name-biofir/"}, {"id": "fda-device-z-0149-2027", "source": "FDA", "category": "device", "recall_number": "Z-0149-2027", "title": "Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel... recall (BioFire Diagnostics, LLC)", "product": "Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A", "reason": "Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results", "hazard_level": "Class II", "company": "BioFire Diagnostics, LLC", "company_location": "Salt Lake City, UT, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "3,871", "codes": "Lot Code: UDI Nos 00815381020314 (30 Kit), 00815381020321 (6 Kit); Model Nos RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit); Lot Numbers 0638426, 0638526, 0676426, 0676526, 0679726, 0804826, 0804926, 0805026, 0883126, 0922126, 0941426, 0941526, 0997926, 0998026, 1020626, 1020726, 1077326, 1105326, 1118926, 1119026, 1119526, 1219226, 1239726, 1286526, 1286626, 1287326, 1287426, 1346226, 1346326, 1346426, 1403026, 1403126, 1403226, 1419326, 1419426, 1437626, 1479026, 1560626, 1560726, 1611826, 1611926, 1656926, 1683826, 1859726", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0149-2027%22", "url": "https://recallledger.net/recalls/device-z-0149-2027-generic-name-filmarray-pneumonia-panel-plus-generic-name-filmarray/"}, {"id": "fda-device-z-0148-2027", "source": "FDA", "category": "device", "recall_number": "Z-0148-2027", "title": "Generic Name: FilmArray¿ Pneumonia Panel  Generic Name: FilmArray¿ Pneumonia Panel ... recall (BioFire Diagnostics, LLC)", "product": "Generic Name: FilmArray¿ Pneumonia Panel  Generic Name: FilmArray¿ Pneumonia Panel  Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144).  Software Version: N/A  Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)  Component: N/A", "reason": "Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results", "hazard_level": "Class II", "company": "BioFire Diagnostics, LLC", "company_location": "Salt Lake City, UT, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "4,892", "codes": "Lot Code: UDI nos 00815381020178 (30 pack), 00815381020185 (6 pack); Model Nos RFIT-PRT-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kit); Lot Numbers 0638726, 0676626, 0676726, 0716526, 0727826, 0767926, 0804526, 0804626, 0860926, 0882826, 0882926, 0883026, 0914626, 0914726, 0914826, 0914926, 0969126, 0969726, 0978026, 0978126, 0978226, 0978326, 0997626, 0997826, VK0997826, 0999226, 1020826, 1020926, 1105426, 1119126, 1119226, 1119326, 1119426, 1151826, 1152326, 1152426, 1179726, 1219026, 1267526, 1286226, 1286326, 1286426, 1346126, 1402726, 1402826, 1402926, 1419126, 1419226, 1437526, 1478926, 1560326, 1560426, 1560526, 1630726, 1656826, 1683726, 1702326, 1708826", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0148-2027%22", "url": "https://recallledger.net/recalls/device-z-0148-2027-generic-name-filmarray-pneumonia-panel-generic-name-filmarray-pne/"}, {"id": "fda-device-z-0146-2027", "source": "FDA", "category": "device", "recall_number": "Z-0146-2027", "title": "iFuse TORQ Implant System  Model/Catalog Number: 10055T recall (SI-BONE, Inc.)", "product": "iFuse TORQ Implant System  Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)", "reason": "The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.", "hazard_level": "Class II", "company": "SI-BONE, Inc.", "company_location": "Santa Clara, CA, United States", "date": "2026-08-21", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.", "states": ["FL", "GA", "HI", "NC", "OH", "PA", "SD", "TX", "VA"], "nationwide": true, "quantity": "100 units", "codes": "10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2027%22", "url": "https://recallledger.net/recalls/device-z-0146-2027-ifuse-torq-implant-system-model-catalog-number-10055t-10x55mm-1006/"}, {"id": "fda-device-z-0142-2027", "source": "FDA", "category": "device", "recall_number": "Z-0142-2027", "title": "NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number... recall (Neuronetics, Inc.)", "product": "NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:    1. NeuroStar 2.0 US; Part Number: 81-01315-000.     2. NeuroStar 3.0 US; Part Number: 81-02315-000.     3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100.     4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000.     5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000.     6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000.     7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000.", "reason": "Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.", "hazard_level": "Class II", "company": "Neuronetics, Inc.", "company_location": "Malvern, PA, United States", "date": "2026-08-24", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Japan and South Korea.", "states": [], "nationwide": true, "quantity": "179 units", "codes": "NeuroStar Software Versions 3.6, 3.7, 3.8   1. NeuroStar 2.0 US; Part Number: 81-01315-000; UDI-DI: 00869378000100.   2. NeuroStar 3.0 US; Part Number: 81-02315-000; UDI-DI: 00869378000117.   3. NeuroStar 2.X to 3.2 Upgrade Kit; Part Number: 81-25000-100; UDI-DI: 00869378000193.   4. NeuroStar Upgrade Kit 3.0 US; Part Number: 81-35000-000; UDI-DI: 00869378000155.   5. NeuroStar Mobile Console 3.6, 120V, US; Part Number: 81-03315-000; UDI-DI: 00850005944058.   6. NeuroStar Mobile Console 3.7, 120V, US; Part Number: 81-04315-000; UDI-DI: 00850005944522.   7. NeuroStar Mobile Console 3.8, 120V, US; Part Number: 81-05315-000; UDI-DI: 00850005944621.   NeuroStar HP Coil Assembly Part Number: 81-01000-200. Coil Serial Numbers: 40203, 40208, 40202, 40204, 40206, 40205, 40207, 40209, 40210, 40211, 40212, 40213, 40214, 40215, 40216, 40217, 40218, 40219, 40220, 40221, 40222, 40223, 40224, 40225, 40227, 40228, 40226, 40229, 40230, 40231, 40232, 40233, 40234, 40236, 40235, 40238, 40239, 40240, 40241, 40242, 40243, 40244, 40245, 40246, 40247, 40248, 40249, 40250, 40251, 40252, 40253, 40254, 40255, 40256, 40257, 40258, 40259, 40260, 40261, 40262, 40263, 40265, 40266, 40267, 40264, 40283, 40284, 40285, 40286, 40287, 40288, 40289, 40290, 40291, 40293, 40292, 40294, 40295, 40296, 40297, 40298, 40299, 40300, 40301, 40302, 40303, 40304, 40305, 40306, 40307, 40308, 40309, 40310, 40311, 40312, 40313, 40314, 40315, 40316, 40317, 40318, 40320, 40319, 40321, 40322, 40323, 40324, 40325, 40326, 40327, 40328, 40329, 40331, 40332, 40333, 40334, 40335, 40336, 40337, 40338, 40339, 40340, 40341, 40342, 40343, 40344, 40347, 40346, 40345, 40348, 40349, 40350, 40353, 40352, 40351, 40354, 40355, 40356, 40357, 40358, 40359, 40360, 40371, 40372, 40373, 40374, 40375, 40376, 30643, 40274, 30638, 40281, 40199, 30671, 40201, 40272, 30641, 40278, 30646, 30653, 30640, 30647, 30652, 40275, 30648, 40197, 40279, 30650, 30639, 30623, 40198, 40280, 40270, 30645, 30654, 30636, 40200, 30635, 40282, 30606, 30607, 30608, 30609, 30610, 30611, 30624, 30625, 30630, 30631, 30632, 30633, 30634, 30655, 30656, 30657, 30658, 30659, 30660, 30622, 30621, 30626, 30614, 30620, 30616, 30619, 30615, 30617, 30661, 30662, 30663, 30664, 30665, 30627, 30628, 30629, 30644, 40268, 40269.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2027%22", "url": "https://recallledger.net/recalls/device-z-0142-2027-neurostar-advanced-therapy-system-contains-the-neurostar-hp-coil-asse/"}, {"id": "fda-device-z-0141-2027", "source": "FDA", "category": "device", "recall_number": "Z-0141-2027", "title": "Brand Name: IOMAX  Product Name: IOMAX Cortical Module  Model/Catalog Number:... recall (Cadwell Industries Inc)", "product": "Brand Name: IOMAX  Product Name: IOMAX Cortical Module  Model/Catalog Number: 190296-200  UDI-DI code: 00840067100653  Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V.  Component: Is the cortical component of the IOMAX system", "reason": "Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.", "hazard_level": "Class II", "company": "Cadwell Industries Inc", "company_location": "Kennewick, WA, United States", "date": "2026-08-18", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.", "states": ["TN"], "nationwide": true, "quantity": "23", "codes": "Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Lot Code: These devices are identified by the serial numbers listed below:  19029607AA0326007 19029607AA0226013 19029607AA0426028 19029607AA0226010 19029607AA0226007 19029607AA0326026 19029607AA0226015 19029607AA0326020 19029607AA0326018 19029607AA0326021 19029607AA0326022 19029607AA0226009 19029607AA0526022 19029607AA0326017 19029607AA0326027 19029607AA0326016 19029607AA0226016 19029607AA0326028 19029607AA0326024 19029607AA0326025 19029607AA0326023 19029607AA0326031 19029607AA0326006", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0141-2027%22", "url": "https://recallledger.net/recalls/device-z-0141-2027-brand-name-iomax-product-name-iomax-cortical-module-model-catalog/"}, {"id": "fda-device-z-0140-2027", "source": "FDA", "category": "device", "recall_number": "Z-0140-2027", "title": "BD Phoenix Panel NMIC-306. Catalog Number: 449292. recall (Becton Dickinson & Co.)", "product": "BD Phoenix Panel NMIC-306. Catalog Number: 449292.", "reason": "Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.", "hazard_level": "Class II", "company": "Becton Dickinson & Co.", "company_location": "Sparks, MD, United States", "date": "2026-08-13", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "669,200 units", "codes": "Catalog Number: 449292.  UDI Numbers: (10)5301934(17)26 1102(30)0025(01)3 0382904492923, (10)5301046(17)26 1107(30)0025(01)3 0382904492923, (10)5301019(17)26 1105(30)0025(01)3 0382904492923, (10)5301058(17)26 1108(30)0025(01)3 0382904492923, (10)5301088(17)26 1109(30)0025(01)3 0382904492923, (10)5324448(17)26 1111(30)0025(01)3 0382904492923, (10)5325592(17)26 1122(30)0025(01)3 0382904492923, (10)5336528(17)26 1125(30)0025(01)3 0382904492923, (10)5336554(17)26 1130(30)0025(01)3 0382904492923, (10)5336667(17)26 1203(30)0025(01)3 0382904492923, (10)5336716(17)26 1206(30)0025(01)3 0382904492923, (10)5343520(17)26 1209(30)0025(01)3 0382904492923, (10)5343522(17)26 1221(30)0025(01)3 0382904492923, (10)5350942(17)26 1226(30)0025(01)3 0382904492923, (10)5350876(17)26 1223(30)0025(01)3 0382904492923, (10)5350972(17)26 1228(30)0025(01)3 0382904492923, (10)6006439(17)26 1231(30)0025(01)3 0382904492923, (10)6006497(17)27 0104(30)0025(01)3 0382904492923, (10)6006475(17)27 0103(30)0025(01)3 0382904492923, (10)6013345(17)27 0111(30)0025(01)3 0382904492923, (10)6013300(17)27 0109(30)0025(01)3 0382904492923, (10)6013963(17)27 0118(30)0025(01)3 0382904492923, (10)6013924(17)27 0117(30)0025(01)3 0382904492923, (10)6034519(17)27 0131(30)0025(01)3 0382904492923, (10)6042012(17)27 0203(30)0025(01)3 0382904492923, (10)6042040(17)27 0204(30)0025(01)3 0382904492923, (10)6042153(17)27 0208(30)0025(01)3 0382904492923, (10)6069030(17)27 0309(30)0025(01)3 0382904492923, (10)6082661(17)27 0313(30)0025(01)3 0382904492923, (10)6098326(17)27 0331(30)0025(01)3 0382904492923, (10)6098427(17)27 0405(30)0025(01)3 0382904492923, (10)6104765(17)27 0411(30)0025(01)3 0382904492923, (10)6125411(17)27 0427(30)0025(01)3 0382904492923, (10)6128662(17)27 0430(30)0025(01)3 0382904492923, (10)6138197(17)27 0505(30)0025(01)3 0382904492923, (10)6148207(17)27 0519(30)0025(01)3 0382904492923, (10)6148231(17)27 0520(30)0025(01)3 0382904492923.  Lot Numbers: 5301934, 5301046, 5301019, 5301058, 5301088, 5324448, 5325592, 5336528, 5336554, 5336667, 5336716, 5343520, 5343522, 5350942, 5350876, 5350972, 6006439, 6006497, 6006475, 6013345, 6013300, 6013963, 6013924, 6034519, 6042012, 6042040, 6042153, 6069030, 6082661, 6098326, 6098427, 6104765, 6125411, 6128662, 6138197, 6148207, 6148231.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0140-2027%22", "url": "https://recallledger.net/recalls/device-z-0140-2027-bd-phoenix-panel-nmic-306-catalog-number-449292/"}, {"id": "fda-device-z-0139-2027", "source": "FDA", "category": "device", "recall_number": "Z-0139-2027", "title": "BD Phoenix Panel NMIC-312. Catalog Number: 449082. recall (Becton Dickinson & Co.)", "product": "BD Phoenix Panel NMIC-312. Catalog Number: 449082.", "reason": "Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.", "hazard_level": "Class II", "company": "Becton Dickinson & Co.", "company_location": "Sparks, MD, United States", "date": "2026-08-13", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "553,625 units", "codes": "Catalog Number: 449082.  UDI Numbers: (10)5324466(17)26 1116(30)0025(01)3 0382904490820, (10)5349874(17)26 1209(30)0025(01)3 0382904490820, (10)6008828(17)26 1226(30)0025(01)3 0382904490820, (10)5350977(17)26 1228(30)0025(01)3 0382904490820, (10)6028392(17)27 0120(30)0025(01)3 0382904490820, (10)6034513(17)27 0131(30)0025(01)3 0382904490820, (10)6042998(17)27 0202(30)0025(01)3 0382904490820, (10)6042021(17)27 0203(30)0025(01)3 0382904490820, (10)6056431(17)27 0217(30)0025(01)3 0382904490820, (10)6069033(17)27 0309(30)0025(01)3 0382904490820, (10)6083447(17)27 0327(30)0025(01)3 0382904490820, (10)6098295(17)27 0330(30)0025(01)3 0382904490820, (10)6104811(17)27 0412(30)0025(01)3 0382904490820, (10)6104042(17)27 0419(30)0025(01)3 0382904490820, (10)6118556(17)27 0421(30)0025(01)3 0382904490820, (10)6125526(17)27 0501(30)0025(01)3 0382904490820, (10)6128740(17)27 0503(30)0025(01)3 0382904490820, (10)6132650(17)27 0508(30)0025(01)3 0382904490820, (10)6132735(17)27 0510(30)0025(01)3 0382904490820, (10)6148198(17)27 0518(30)0025(01)3 0382904490820, (10)6148397(17)27 0524(30)0025(01)3 0382904490820, (10)6153088(17)27 0525(30)0025(01)3 0382904490820, (10)6153231(17)27 0526(30)0025(01)3 0382904490820, (10)6160397(17)27 0602(30)0025(01)3 0382904490820, (10)6160450(17)27 0605(30)0025(01)3 0382904490820, (10)6166259(17)27 0604(30)0025(01)3 0382904490820, (10)6166265(17)27 0606(30)0025(01)3 0382904490820, (10)6181978(17)27 0622(30)0025(01)3 0382904490820, (10)6181006(17)27 0623(30)0025(01)3 0382904490820, (10)6181015(17)27 0623(30)0025(01)3 0382904490820, (10)6181164(17)27 0626(30)0025(01)3 0382904490820, (10)6181151(17)27 0626(30)0025(01)3 0382904490820, (10)6181991(17)27 0622(30)0025(01)3 0382904490820, (10)6188614(17)27 0703(30)0025(01)3 0382904490820, (10)6188641(17)27 0703(30)0025(01)3 0382904490820, (10)6188683(17)27 0705(30)0025(01)3 0382904490820, (10)6188905(17)27 0710(30)0025(01)3 0382904490820, (10)6188922(17)27 0711(30)0025(01)3 0382904490820, (10)6195847(17)27 0713(30)0025(01)3 0382904490820, (10)6195877(17)27 0714(30)0025(01)3 0382904490820.  Lot Numbers: 5324466, 5349874, 6008828, 5350977, 6028392, 6034513, 6042998, 6042021, 6056431, 6069033, 6083447, 6098295, 6104811, 6104042, 6118556, 6125526, 6128740, 6132650, 6132735, 6148198, 6148397, 6153088, 6153231, 6160397, 6160450, 6166259, 6166265, 6181978, 6181006, 6181015, 6181164, 6181151, 6181991, 6188614, 6188641, 6188683, 6188905, 6188922, 6195847, 6195877.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0139-2027%22", "url": "https://recallledger.net/recalls/device-z-0139-2027-bd-phoenix-panel-nmic-312-catalog-number-449082/"}, {"id": "fda-device-z-0138-2027", "source": "FDA", "category": "device", "recall_number": "Z-0138-2027", "title": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined... recall (Medtronic Sofamor Danek USA Inc)", "product": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are produced from a fiber form of DBM Crunch\" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.", "reason": "Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue.  Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.", "hazard_level": "Class II", "company": "Medtronic Sofamor Danek USA Inc", "company_location": "Memphis, TN, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.", "states": ["AL", "AR", "CO", "DE", "FL", "GA", "IL", "KS", "MD", "MI", "OK", "TX", "VA"], "nationwide": true, "quantity": "20", "codes": "UDI-DI: 00643169122932. Serial Numbers: A62881-014 through A62881-033, specifically: A62881-014, A62881-015, A62881-016, A62881-017, A62881-018, A62881-019, A62881-020, A62881-021, A62881-022, A62881-023, A62881-024, A62881-025, A62881-026, A62881-027, A62881-028, A62881-029, A62881-030, A62881-031, A62881-032, A62881-033", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2027%22", "url": "https://recallledger.net/recalls/device-z-0138-2027-grafton-dbm-and-grafton-plus-dbm-contain-demineralized-human-bone-ti/"}, {"id": "fda-device-z-0137-2027", "source": "FDA", "category": "device", "recall_number": "Z-0137-2027", "title": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue  combined... recall (Medtronic Sofamor Danek USA Inc)", "product": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue  combined with an inert additive to yield a demineralized bone matrix (DBM)  allograft product having a particular physical form and/or handling property.  Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form  of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are  produced from a fiber form of DBM Crunch\" also contains demineralized bone  chips/cubes, while Grafton DBM Orthoblend contains non-demineralized  cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are  malleable and can be molded or cut into various sizes and shapes according to the  intended implant site.", "reason": "Medtronic identified through donor record review that the donor for Medtronic  batch A62881 did not meet all Medtronic donor eligibility requirements related to  the presence of microbial organisms.  While the batch passed finished product  sterility testing Medtronic is retrieving any unused product manufactured from the  donor tissue.    Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection", "hazard_level": "Class II", "company": "Medtronic Sofamor Danek USA Inc", "company_location": "Memphis, TN, United States", "date": "2026-08-12", "report_date": "2026-10-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of OK, VA, CO, AR, FL, TX, MD, DE, IL, MI, KS, AL, GA.", "states": ["AL", "AR", "CO", "DE", "FL", "GA", "IL", "KS", "MD", "MI", "OK", "TX", "VA"], "nationwide": true, "quantity": "18", "codes": "UDI-DI: 00643169123021. Serial Numbers: A62881-034 through A62881-051, specifically:  A62881-034, A62881-035, A62881-036, A62881-037, A62881-038, A62881-039, A62881-040, A62881-041, A62881-042, A62881-043, A62881-044, A62881-045, A62881-046, A62881-047, A62881-048, A62881-049, A62881-050, A62881-051", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2027%22", "url": "https://recallledger.net/recalls/device-z-0137-2027-grafton-dbm-and-grafton-plus-dbm-contain-demineralized-human-bone-ti/"}, {"id": "fda-food-h-0011-2027", "source": "FDA", "category": "food", "recall_number": "H-0011-2027", "title": "Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration   5... recall (The Better Bakehouse Snack Company)", "product": "Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration   5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton containing 5 individually wrapped packages of two donuts each. UPC: 850041392103. The Better Bakehouse Snack Co.  3651 Lindell Rd, Suite D700  Las Vegas, NV 89103", "reason": "Undeclared Milk.", "hazard_level": "Class I", "company": "The Better Bakehouse Snack Company", "company_location": "Las Vegas, NV, United States", "date": "2026-08-17", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Product was distributed nationwide.", "states": [], "nationwide": true, "quantity": "10,602 consumer units", "codes": "Lot # 26078 BEST BY: 09/15/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0011-2027%22", "url": "https://recallledger.net/recalls/food-h-0011-2027-donutful-chocolate-dipped-vanilla-cake-donuts-7-05oz-10ct-case-confi/"}, {"id": "fda-device-z-0119-2027", "source": "FDA", "category": "device", "recall_number": "Z-0119-2027", "title": "Intellijoint Navigation System: Workstation G2 Configured recall (Intellijoint Surgical, Inc.)", "product": "Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249", "reason": "A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.", "hazard_level": "Class II", "company": "Intellijoint Surgical, Inc.", "company_location": "Kitchener, N/A, Canada", "date": "2026-08-28", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.", "states": ["CA", "MS", "NJ", "TX"], "nationwide": true, "quantity": "8", "codes": "REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0119-2027%22", "url": "https://recallledger.net/recalls/device-z-0119-2027-intellijoint-navigation-system-workstation-g2-configured-ref-000-02/"}, {"id": "fda-device-z-0117-2027", "source": "FDA", "category": "device", "recall_number": "Z-0117-2027", "title": "TufTex¿ Over-the-Wire Embolectomy Catheter recall (LeMaitre Vascular, Inc.)", "product": "TufTex¿ Over-the-Wire Embolectomy Catheter;  Catalog Number: E1651-88;", "reason": "Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.", "hazard_level": "Class II", "company": "LeMaitre Vascular, Inc.", "company_location": "Burlington, MA, United States", "date": "2026-08-28", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.", "states": ["CA", "FL", "GA", "KY", "LA", "NJ", "OH", "PA", "SC"], "nationwide": true, "quantity": "54", "codes": "Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2027%22", "url": "https://recallledger.net/recalls/device-z-0117-2027-tuftex-over-the-wire-embolectomy-catheter-catalog-number-e1651-88/"}, {"id": "fda-device-z-0116-2027", "source": "FDA", "category": "device", "recall_number": "Z-0116-2027", "title": "T1 Patient Monitor. Operator's Manual: T1 Patient Monitor recall (Mindray DS USA, Inc.)", "product": "T1 Patient Monitor. Operator's Manual: T1 Patient Monitor", "reason": "Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions", "hazard_level": "Class III", "company": "Mindray DS USA, Inc.", "company_location": "Mahwah, NJ, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "4,946 units", "codes": "T1 Patient Monitor Operator's Manual:  1. T1 Operator's Manual up to and including revision 14.0; Part No. 046-006734-00", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2027%22", "url": "https://recallledger.net/recalls/device-z-0116-2027-t1-patient-monitor-operator-s-manual-t1-patient-monitor/"}, {"id": "fda-device-z-0115-2027", "source": "FDA", "category": "device", "recall_number": "Z-0115-2027", "title": "cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 recall (Mindray DS USA, Inc.)", "product": "cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12", "reason": "Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions", "hazard_level": "Class III", "company": "Mindray DS USA, Inc.", "company_location": "Mahwah, NJ, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "1,699 units", "codes": "Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0115-2027%22", "url": "https://recallledger.net/recalls/device-z-0115-2027-cpm-series-patient-monitor-operator-s-manual-cpm-8-cpm-12/"}, {"id": "fda-device-z-0114-2027", "source": "FDA", "category": "device", "recall_number": "Z-0114-2027", "title": "Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V recall (Mindray DS USA, Inc.)", "product": "Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V", "reason": "Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions", "hazard_level": "Class III", "company": "Mindray DS USA, Inc.", "company_location": "Mahwah, NJ, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "39,891 units", "codes": "Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00   2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00  3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2027%22", "url": "https://recallledger.net/recalls/device-z-0114-2027-passport-series-patient-monitor-operator-s-manuals-8-12-12m-17/"}, {"id": "fda-device-z-0113-2027", "source": "FDA", "category": "device", "recall_number": "Z-0113-2027", "title": "BeneView Series. Operator's Manuals: T5 / T8 recall (Mindray DS USA, Inc.)", "product": "BeneView Series. 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UDI-DI: 10809160490808; Kit Lot Numbers: 1671502;  Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2027%22", "url": "https://recallledger.net/recalls/device-z-0098-2027-robotic-prostatectomy-pack-model-item-number-kit-namc423-11/"}, {"id": "fda-device-z-0097-2027", "source": "FDA", "category": "device", "recall_number": "Z-0097-2027", "title": "PACK OPEN HEART CFH recall (AVID Medical, Inc.)", "product": "PACK OPEN HEART CFH;  Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "124", "codes": "1. Model/Item Number (Kit): UFCF004-06; UDI-DI: 10809160487334; Kit Lot Numbers: 1666214, 1672814;  2. Model/Item Number (Kit): UFCF004-07; UDI-DI: 10809160513170; Kit Lot Numbers: 1695181;  Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404, NGKT3314;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2027%22", "url": "https://recallledger.net/recalls/device-z-0097-2027-pack-open-heart-cfh-model-item-number-kit-1-ufcf004-06-2-ufcf0/"}, {"id": "fda-device-z-0096-2027", "source": "FDA", "category": "device", "recall_number": "Z-0096-2027", "title": "CRANIOTOMY PACK recall (AVID Medical, Inc.)", "product": "CRANIOTOMY PACK;  Model/Item Number (Kit): WRNM035-20;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "10", "codes": "1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943;  Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0096-2027%22", "url": "https://recallledger.net/recalls/device-z-0096-2027-craniotomy-pack-model-item-number-kit-wrnm035-20/"}, {"id": "fda-device-z-0095-2027", "source": "FDA", "category": "device", "recall_number": "Z-0095-2027", "title": "ENDOVASCULAR PACK recall (AVID Medical, Inc.)", "product": "ENDOVASCULAR PACK;  Model/Item Number (Kit): VAPX014-04;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "33", "codes": "1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273;  Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0095-2027%22", "url": "https://recallledger.net/recalls/device-z-0095-2027-endovascular-pack-model-item-number-kit-vapx014-04/"}, {"id": "fda-device-z-0094-2027", "source": "FDA", "category": "device", "recall_number": "Z-0094-2027", "title": "ADULT HEART TRAY SHANDS JACKS recall (AVID Medical, Inc.)", "product": "ADULT HEART TRAY SHANDS JACKS;  Model/Item Number (Kit): SHND419-08;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "59", "codes": "1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337;  Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0094-2027%22", "url": "https://recallledger.net/recalls/device-z-0094-2027-adult-heart-tray-shands-jacks-model-item-number-kit-shnd419-08/"}, {"id": "fda-device-z-0093-2027", "source": "FDA", "category": "device", "recall_number": "Z-0093-2027", "title": "GYN LAPAROSCOPY/LAPAROTOMY recall (AVID Medical, Inc.)", "product": "GYN LAPAROSCOPY/LAPAROTOMY;  Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "134", "codes": "1. Model/Item Number (Kit): WRNM002-15; UDI-DI: 10809160487181; Kit Lot Numbers: 1666722;  2. Model/Item Number (Kit): FBCH108-03; UDI-DI: 10809160399781; Kit Lot Numbers: 1659079, 1696378;  Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKU3975, NGKU2887;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0093-2027%22", "url": "https://recallledger.net/recalls/device-z-0093-2027-gyn-laparoscopy-laparotomy-model-item-number-kit-1-wrnm002-15-2/"}, {"id": "fda-device-z-0092-2027", "source": "FDA", "category": "device", "recall_number": "Z-0092-2027", "title": "DAVINCI TRUCUSTOM BUNDLE recall (AVID Medical, Inc.)", "product": "DAVINCI TRUCUSTOM BUNDLE;  Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;", "reason": "Product may be potentially contaminated with a lubricant used during the manufacturing process.", "hazard_level": "Class II", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.", "states": ["AZ", "CA", "FL", "MD", "NE", "TX"], "nationwide": true, "quantity": "144", "codes": "1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251;  2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700;  Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2027%22", "url": "https://recallledger.net/recalls/device-z-0092-2027-davinci-trucustom-bundle-model-item-number-kit-1-samm064-27-2/"}, {"id": "fda-device-z-0088-2027", "source": "FDA", "category": "device", "recall_number": "Z-0088-2027", "title": "Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog... recall (Medtronic MiniMed, Inc.)", "product": "Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.", "reason": "Some MiniMed Flex insulin pumps were released with missing (i.e., devices with  no result  or  abort  test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.", "hazard_level": "Class II", "company": "Medtronic MiniMed, Inc.", "company_location": "Northridge, CA, United States", "date": "2026-08-20", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.", "states": ["AR", "AZ", "CO", "FL", "KS", "KY", "LA", "MI", "MN", "NJ", "NY", "OH", "PA", "SD", "TN", "TX", "WV"], "nationwide": true, "quantity": "25", "codes": "MMT-8072 Lot Code: Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796,  FB00015799, FB00015801, FB00015977, FB00017271.  UDI-DI/GTIN: 00763000848156  Note: Initially 25 pumps were identified as put into service, however 2 were shipped to Marketing Team Members and recovered. 3 Pumps were returned through complaint process. Final total of pumps available in the field is 20.  MMT-8062 Lot Code: Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760,  FB00015797  UDI-DI/GTIN: 00763000848149  (Serial Numbers: FB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members).", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2027%22", "url": "https://recallledger.net/recalls/device-z-0088-2027-brand-name-minimed-flex-product-name-minimed-flex-insulin-pump-model/"}, {"id": "fda-device-z-0087-2027", "source": "FDA", "category": "device", "recall_number": "Z-0087-2027", "title": "Rollator recall (Medline Industries, LP)", "product": "Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS", "reason": "The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame  tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-14", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "835 units", "codes": "Lot Numbers: 05425080001 05426040001", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2027%22", "url": "https://recallledger.net/recalls/device-z-0087-2027-rollator-bariatric-basic-steel-blue-mechanical-walker-with-four-le/"}, {"id": "fda-device-z-0086-2027", "source": "FDA", "category": "device", "recall_number": "Z-0086-2027", "title": "Rollator recall (Medline Industries, LP)", "product": "Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS", "reason": "The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame  tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-14", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "1824 units", "codes": "Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2027%22", "url": "https://recallledger.net/recalls/device-z-0086-2027-rollator-bariatric-basic-steel-burgundy-mechanical-walker-with-fou/"}, {"id": "fda-device-z-0085-2027", "source": "FDA", "category": "device", "recall_number": "Z-0085-2027", "title": "BARD EP XT DECAPOLAR STEERABLE recall (Stryker Sustainability Solutions)", "product": "BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007", "reason": "Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.", "hazard_level": "Class II", "company": "Stryker Sustainability Solutions", "company_location": "Tempe, AZ, United States", "date": "2026-08-18", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of NJ.", "states": ["NJ"], "nationwide": true, "quantity": "10", "codes": "UDI-DI: 00885825003838. Lot: 5640704, Serial: 5097742, Distribution Date: May 26th 2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2027%22", "url": "https://recallledger.net/recalls/device-z-0085-2027-bard-ep-xt-decapolar-steerable-diagnostic-ep-catheter-6f-large-4-0/"}, {"id": "fda-device-z-0080-2027", "source": "FDA", "category": "device", "recall_number": "Z-0080-2027", "title": "Glypto Device recall (Limitless Cryo Spa LLC)", "product": "Glypto Device, Glypto Cryo Machine;", "reason": "Lack of 510(k) clearance.", "hazard_level": "Class II", "company": "Limitless Cryo Spa LLC", "company_location": "Ocean, NJ, United States", "date": "2026-08-24", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "219", "codes": "All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2027%22", "url": "https://recallledger.net/recalls/device-z-0080-2027-glypto-device-glypto-cryo-machine/"}, {"id": "fda-device-z-0079-2027", "source": "FDA", "category": "device", "recall_number": "Z-0079-2027", "title": "Presource Packs containing Medtronic Microstream Components:    Intubation Kit ... recall (Cardinal Health 200, LLC)", "product": "Presource Packs containing Medtronic Microstream Components:    Intubation Kit  Catalog Numbers   AN23366084  AN23366085  AN2336608H  AN2336608J    Intubating Bag Kit  Catalog Number OMSVM4166A    Intubation UH Kit  Catalog Number AN2336608G", "reason": "Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-19", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Pending", "states": [], "nationwide": false, "quantity": "210 total kits", "codes": "AN23366084    UDI-DI 10197106950074    Kit lot 40711  AN23366085    UDI-DI 10198956177987    Kit lot 46520  AN2336608H    UDI-DI 10197106159828    Kit lots                 20866   23139   24264   25795   27111   27899   29023   29488   30527   31037   31698   32777   33326  AN2336608J    UDI-DI 10197106704035    Kit lots                 33461   33624   35231   35535   35689   36554   36600   36825   38327   38891   40511   41864   43975   44933   45972   47547   47897   48088   48528   49440    OMSVM4166A    UDI-DI 10198956162259    Kit Lots                 47765   50521   53221   53929   54565   54644    AN2336608G    UDI-DI 10197106052105    Kit lots                 18464   18569   19224", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0079-2027%22", "url": "https://recallledger.net/recalls/device-z-0079-2027-presource-packs-containing-medtronic-microstream-components-intuba/"}, {"id": "fda-device-z-0078-2027", "source": "FDA", "category": "device", "recall_number": "Z-0078-2027", "title": "Spectral CT and Spectral CT 7500 RT recall (PHILIPS MEDICAL SYSTEMS)", "product": "Spectral CT and Spectral CT 7500 RT;  Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);  Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);", "reason": "Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, MA, MD, MN, NC, NY, OH, PA, TX, VA, WV and the countries of Australia, Austria, Belgium, Bulgaria, China, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Macao, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Nicaragua, Norway, Palestine, Panama, Philippines, Poland, Portugal, Romania, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam.", "states": ["AR", "AZ", "CA", "CO", "FL", "GA", "HI", "IL", "IN", "KY", "MA", "MD", "MN", "NC", "NY", "OH", "PA", "TX", "VA", "WV"], "nationwide": true, "quantity": "539", "codes": "1. Model Number: 728333 (U.S.); UDI-DI: 1. 00884838101111, 2. 00884838127876; Serial Numbers: 12055, 12054, 12052, 398006, 12044, 12045, 10237, 10056, 10194, 12059, 10278, 10319, 10143, 10081, 12047, 12048, 10198, 12046, 12043, 10262, 12042, 12041, 10186, 10241, 12039, 10317, 10316, 10264, 10127, 12038, 12037, 396014, 12036, 398005, 10016, 12034, 10076, 10074, 12035, 10021, 10018, 10023, 12032, 12029, 398003, 398004, 396013, 12027, 12026, 12023, 12025, 12024, 12021, 12022, 12017, 12019, 12018, 12020, 10312, 10311, 10310, 10305, 12016, 10308, 10306, 10307, 12014, 12013, 10304, 10302, 12012, 12011, 12010, 396012, 12007, 10301, 12009, 10300, 10299, 12008, 12006, 12005, 10298, 12002, 12003, 10294, 10292, 12001, 12000, 10293, 10290, 396011, 396010, 10291, 10289, 10279, 10288, 10287, 10284, 10286, 10281, 10285, 10271, 10276, 396009, 10280, 10275, 10273, 10277, 396008, 396006, 396007, 10274, 10272, 10270, 10269, 10252, 10154, 10268, 10267, 10261, 10266, 10265, 10219, 10263, 10260, 10157, 10259, 10224, 10240, 10257, 10246, 10258, 10253, 10256, 10251, 10254, 10243, 10250, 10248, 10247, 10244, 10249, 10245, 10236, 10223, 10239, 10242, 10235, 10234, 10221, 10231, 10209, 10232, 10228, 10226, 10229, 10230, 10220, 10217, 10227, 10225, 10218, 10222, 10212, 10214, 10215, 10213, 10211, 10210, 396004, 10208, 10207, 10206, 10204, 10202, 10197, 10203, 10205, 10200, 10201, 10199, 10196, 10195, 10193, 10175, 10190, 10189, 10188, 10191, 10187, 10184, 10185, 10183, 10181, 10180, 10182, 10179, 10178, 10177, 10174, 10176, 10173, 10172, 10171, 10170, 10168, 10169, 10167, 10163, 10165, 10166, 10158, 10161, 10160, 10148, 10159, 10156, 10155, 10153, 10152, 10150, 10151, 10149, 10147, 10146, 10145, 10144, 10141, 10142, 10140, 10138, 10139, 10137, 10134, 10136, 10135, 10133, 10132, 10130, 10131, 10128, 10129, 10126, 10049, 10124, 10119, 10123, 10121, 10120, 10118, 10122, 10032, 10116, 10113, 10115, 10114, 10111, 10112, 10110, 10104, 396003, 396001, 10109, 10108, 10107, 10106, 10105, 10097, 10103, 10100, 10102, 10101, 10098, 10099, 10090, 10096, 10095, 10093, 10094, 10091, 10086, 10088, 10085, 10089, 10087, 10084, 10082, 10080, 10077, 10078, 10075, 10069, 10072, 10071, 10070, 10067, 10068, 10066, 10065, 10062, 10061, 10060, 10057, 10058, 10052, 10055, 10053, 10050, 10047, 10045, 10048, 10044, 10042, 10043, 10041, 10040, 10039, 10038, 10036, 10035, 10034, 10031, 10033, 10027, 10024, 10020, 10019, 10017, 10015, 10013, 10117, 10079, 10314, 12028, 12015, 10303, 10233, 10162, 12033, 12031, 12030, 10092, 10046, 10125, 10063, 10025;  2. Model Number: 728340 (Outside U.S.); UDI-DI: 00884838111103;  Serial Numbers: 397035, 397004, 397168, 397167, 397164, 397159, 397160, 397155, 397153, 397152, 397150, 397151, 397148, 397147, 397146, 397145, 397141, 397142, 397139, 397140, 397137, 397133, 397132, 397130, 397126, 397125, 397123, 397121, 397120, 397117, 397116, 397115, 397112, 397110, 397108, 397107, 397106, 397102, 397101, 397099, 397098, 397096, 397095, 397093, 397091, 397085, 397089, 397088, 397087, 397086, 397084, 397083, 397082, 397080, 397081, 397079, 397077, 397076, 397075, 397073, 397072, 397071, 397070, 397067, 397066, 397065, 397062, 397064, 397063, 397060, 397061, 397059, 397058, 397056, 397055, 397054, 397053, 397050, 397049, 397047, 397048, 397046, 397045, 397043, 397044, 397041, 397040, 397039, 397038, 397037, 397036, 397034, 397033, 397032, 397026, 397031, 397029, 397028, 397027, 397025, 397024, 397023, 397022, 397021, 397020, 397018, 397019, 397016, 397017, 397015, 397014, 397012, 397009, 397013, 397011, 397003, 397010, 397008, 397006, 397002, 397005, 397007, 397105, 397030, 397128, 397119, 397097;  3. Model Number: 728344 (Outside U.S.); UDI-DI: 00884838117822; Serial Numbers: 397170, 397162, 397158, 397149, 397166, 397165, 397163, 397161, 397156, 397143, 397136, 397135, 397131, 397129, 397127, 397122, 397124, 397118, 397114, 397113, 397111, 397104, 397100, 397094, 397092, 397090, 397078, 397074, 397068, 397057, 397103;  4. Model Number: 728345 (Outside U.S.); UDI-DI: 00884838123748; Serial Numbers: 14004, 399003, 14001, 14000;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2027%22", "url": "https://recallledger.net/recalls/device-z-0078-2027-spectral-ct-and-spectral-ct-7500-rt-software-version-numbers-5-2-x/"}, {"id": "fda-device-z-0077-2027", "source": "FDA", "category": "device", "recall_number": "Z-0077-2027", "title": "HALYARD Laparoscopy Comprehensive Pack II  REF: 49332 recall (GRI Medical & Electronic Technology Co., Ltd.)", "product": "HALYARD Laparoscopy Comprehensive Pack II  REF: 49332", "reason": "Laparoscopy packs labeled as \"latex free\" were found to contain a latex urethral catheter", "hazard_level": "Class II", "company": "GRI Medical & Electronic Technology Co., Ltd.", "company_location": "Jia Xing, N/A, China", "date": "2026-08-26", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of MS.", "states": ["MS"], "nationwide": true, "quantity": "396 kits", "codes": "UDI-DI: 10680651493320 (unit level), 30680651493324 (case level) Lot Numbers: GL25271CXA-Expiry Date: 2029/3/30; GL25296CXA-Expiry Date: 2029/3/30; GL26076CXA-Expiry Date: 2029/5/31", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2027%22", "url": "https://recallledger.net/recalls/device-z-0077-2027-halyard-laparoscopy-comprehensive-pack-ii-ref-49332/"}, {"id": "fda-device-z-0075-2027", "source": "FDA", "category": "device", "recall_number": "Z-0075-2027", "title": "VERIFY Biological Steam Test Pack  Model/Catalog Number: S3069 recall (Steris Corporation)", "product": "VERIFY Biological Steam Test Pack  Model/Catalog Number: S3069", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "233", "codes": "UDI:10724995023864 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0075-2027%22", "url": "https://recallledger.net/recalls/device-z-0075-2027-verify-biological-steam-test-pack-model-catalog-number-s3069/"}, {"id": "fda-device-z-0074-2027", "source": "FDA", "category": "device", "recall_number": "Z-0074-2027", "title": "VERIFY Biological Steam Test Pack  Model/Catalog Number: S3065 recall (Steris Corporation)", "product": "VERIFY Biological Steam Test Pack  Model/Catalog Number: S3065", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "217", "codes": "UDI: 10724995220300 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2027%22", "url": "https://recallledger.net/recalls/device-z-0074-2027-verify-biological-steam-test-pack-model-catalog-number-s3065/"}, {"id": "fda-device-z-0073-2027", "source": "FDA", "category": "device", "recall_number": "Z-0073-2027", "title": "VERIFY Dual Species Self-Contained Biological Indicator  Model/Catalog Number: S3061 recall (Steris Corporation)", "product": "VERIFY Dual Species Self-Contained Biological Indicator  Model/Catalog Number: S3061", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "2205", "codes": "UDI: 50724995023824 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0073-2027%22", "url": "https://recallledger.net/recalls/device-z-0073-2027-verify-dual-species-self-contained-biological-indicator-model-catalog/"}, {"id": "fda-device-z-0072-2027", "source": "FDA", "category": "device", "recall_number": "Z-0072-2027", "title": "VERIFY Dual Species Self-Contained Biological Indicator    Model/Catalog Number: S3060 recall (Steris Corporation)", "product": "VERIFY Dual Species Self-Contained Biological Indicator    Model/Catalog Number: S3060", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1185", "codes": "UDI: 10724995023833 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0072-2027%22", "url": "https://recallledger.net/recalls/device-z-0072-2027-verify-dual-species-self-contained-biological-indicator-model-catal/"}, {"id": "fda-device-z-0071-2027", "source": "FDA", "category": "device", "recall_number": "Z-0071-2027", "title": "VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB007 recall (Steris Corporation)", "product": "VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB007", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "409", "codes": "UDI: 10724995220331 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2027%22", "url": "https://recallledger.net/recalls/device-z-0071-2027-verify-biological-integrator-challenge-pack-model-catalog-number-l/"}, {"id": "fda-device-z-0070-2027", "source": "FDA", "category": "device", "recall_number": "Z-0070-2027", "title": "VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB006 recall (Steris Corporation)", "product": "VERIFY Biological/Integrator Challenge Pack    Model/Catalog Number: LCB006", "reason": "Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction", "hazard_level": "Class II", "company": "Steris Corporation", "company_location": "Mentor, OH, United States", "date": "2026-08-31", "report_date": "2026-10-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "266", "codes": "UDI: 10724995220324 Lot numbers: 260810 - expiration date 08/10/2026 260810A - expiration date 08/10/2026 261106 - expiration date 11/06/2026 270116 - expiration date 01/16/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2027%22", "url": "https://recallledger.net/recalls/device-z-0070-2027-verify-biological-integrator-challenge-pack-model-catalog-number-l/"}, {"id": "fda-food-h-1399-2026", "source": "FDA", "category": "food", "recall_number": "H-1399-2026", "title": "Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil recall (LMSI, LLC)", "product": "Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil, packaged in 3.4 fl oz (100mL), 8.5 fl oz (250mL), and 17 fl oz (500mL) glass bottles, UPC: 799475717185 (on 8.5 fl oz/250mL), 799475717178 (on 17 fl oz/500mL). The 3.4 fl oz/100mL bottles were sold as part of a gift set; the 8.5 fl oz/250mL and 17 fl oz/500mL products were sold individually.", "reason": "Product contains garlic essential oil not approved for culinary use", "hazard_level": "Class II", "company": "LMSI, LLC", "company_location": "Montgomery, OH, United States", "date": "2026-08-29", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Distributed directly to consumers in CA, FL, IL, KY, MO, NC, OH, OR, TN, TX, VA, WA, and WV", "states": ["CA", "FL", "IL", "KY", "MO", "NC", "OH", "OR", "TN", "TX", "VA", "WA", "WV"], "nationwide": false, "quantity": "Approximately 85 liters", "codes": "No codes applied", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1399-2026%22", "url": "https://recallledger.net/recalls/food-h-1399-2026-kofinas-garlic-mediterranean-infused-extra-virgin-olive-oil-packaged/"}, {"id": "fda-food-h-1398-2026", "source": "FDA", "category": "food", "recall_number": "H-1398-2026", "title": "Salata Salad Kitchen Jalapen¿o Avocado Dressing.  Keep Refrigerated.   Packaged in the... recall (Salata Dressings, LLC)", "product": "Salata Salad Kitchen Jalapen¿o Avocado Dressing.  Keep Refrigerated.   Packaged in the following sizes:  1.  12.5 fl. oz. (369 mL), UPC 8 50043-70646 5.   2.  1 gallon jugs, 4 per shipping case. Made by Salata Dressings, 16720 Park Row Dr., Houston, TX  77084.", "reason": "This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier", "hazard_level": "Class I", "company": "Salata Dressings, LLC", "company_location": "Houston, TX, United States", "date": "2026-08-06", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "GA, NC, TX", "states": ["GA", "NC", "TX"], "nationwide": false, "quantity": "1,724 cases", "codes": "1.  Batch Number 2628-106/2628-111 EXP:  11/5/2026; Batch Number  2629-114 / 2629-118 EXP 11/13/2026;  Batch Number  2630-039 / 2630-041 EXP 11/18/2026;   Batch Number 2631-050 / 2631-056 EXP 11/25/2026.    2.  MFG:  07/08/26,  Expires:  10/06/26, Batch # 2628-126 / 2628-143;    MFG:  07/16/26,  Expires:  10/14/26, Batch # 2629-130 / 2629-145;    MFG:  07/21/26,  Expires:  10/20/26, Batch # 2630-045 / 2630-060;    MFG:  07/28/26,  Expires:  10/26/26, Batch 2631-062 / 2631-076#", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1398-2026%22", "url": "https://recallledger.net/recalls/food-h-1398-2026-salata-salad-kitchen-jalapeno-avocado-dressing-keep-refrigerated/"}, {"id": "fda-food-h-1397-2026", "source": "FDA", "category": "food", "recall_number": "H-1397-2026", "title": "7up Tropical beverage recall (Admiral Beverage Corporation)", "product": "7up Tropical beverage, shelf stable, 12oz can in a 12pk wrap, labeled as 7 up Tropical Beverage containing cans that are labeled as 7Up Tropical Zero Sugar which contain full sugar soda. 12 fl oz, UPC: 0 78000 03798 2, Dr Pepper/Seven Up, Inc., 6425 Hall of Fame Lane, Frisco TX 75034.", "reason": "Product may contain undeclared sugar.", "hazard_level": "Class II", "company": "Admiral Beverage Corporation", "company_location": "Pleasant View, UT, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Completed", "distribution": "Product was distributed to Utah.", "states": ["UT"], "nationwide": false, "quantity": "3,240 cases=77,760 cans", "codes": "Lot Code/Batch Code: UT06176 Packing Code (Best By): March 17, 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1397-2026%22", "url": "https://recallledger.net/recalls/food-h-1397-2026-7up-tropical-beverage-shelf-stable-12oz-can-in-a-12pk-wrap-labeled/"}, {"id": "fda-drug-d-0875-2026", "source": "FDA", "category": "drug", "recall_number": "D-0875-2026", "title": "Zoladex recall (TerSera Therapeutics LLC)", "product": "Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.", "reason": "Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.", "hazard_level": "Class II", "company": "TerSera Therapeutics LLC", "company_location": "Deerfield, IL, United States", "date": "2026-08-31", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "296 cartons", "codes": "Lot#: YN0099, Exp 01/31/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0875-2026%22", "url": "https://recallledger.net/recalls/drug-d-0875-2026-zoladex-goserelin-implant-3-6-mg-one-single-use-syringe-packaged-i/"}, {"id": "fda-device-z-3335-2026", "source": "FDA", "category": "device", "recall_number": "Z-3335-2026", "title": "Atellica CH Revised C-Reactive Protein recall (Siemens Healthcare Diagnostics, Inc.)", "product": "Atellica CH Revised C-Reactive Protein (RCRP);  Siemens Material Number (SMN): 11537223;", "reason": "The potential for falsely elevated results.", "hazard_level": "Class II", "company": "Siemens Healthcare Diagnostics, Inc.", "company_location": "Tarrytown, NY, United States", "date": "2026-08-17", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.", "states": ["GA"], "nationwide": true, "quantity": "42940 units (3938 US, 39002 OUS)", "codes": "Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3335-2026%22", "url": "https://recallledger.net/recalls/device-z-3335-2026-atellica-ch-revised-c-reactive-protein-rcrp-siemens-material-numbe/"}, {"id": "fda-device-z-3334-2026", "source": "FDA", "category": "device", "recall_number": "Z-3334-2026", "title": "CHARLOTTE CLAW Screw recall (Wright Medical Technology, Inc.)", "product": "CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System", "reason": "Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.", "hazard_level": "Class II", "company": "Wright Medical Technology, Inc.", "company_location": "arlington, TN, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.", "states": ["CA", "CO", "FL", "ID", "MI", "NJ", "OK", "PA", "TN", "TX", "WI"], "nationwide": true, "quantity": "34", "codes": "UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3334-2026%22", "url": "https://recallledger.net/recalls/device-z-3334-2026-charlotte-claw-screw-ref-40122716-intended-for-use-with-claw-ii-pol/"}, {"id": "fda-device-z-3333-2026", "source": "FDA", "category": "device", "recall_number": "Z-3333-2026", "title": "HOPKINS Telescope 30¿ recall (Karl Storz Endoscopy)", "product": "HOPKINS Telescope 30¿, 4mm REF 10005BA  UDI-DI code: 04048551045121    KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.", "reason": "Due to incorrect inside packaging label for eyepiece.", "hazard_level": "Class II", "company": "Karl Storz Endoscopy", "company_location": "El Segundo, CA, United States", "date": "2026-08-12", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of AZ, CA and MO.", "states": ["AZ", "CA", "MO"], "nationwide": true, "quantity": "6 eyepieces", "codes": "Material Number: 10005BA UDI-DI code: 04048551045121 Serial Numbers: 100011, 100012, 10000Y, and 10000Z", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3333-2026%22", "url": "https://recallledger.net/recalls/device-z-3333-2026-hopkins-telescope-30-4mm-ref-10005ba-udi-di-code-04048551045121/"}, {"id": "fda-device-z-3332-2026", "source": "FDA", "category": "device", "recall_number": "Z-3332-2026", "title": "Systems/units containing affected software/SQL  BECKMAN COULTER CHEMISTRY ANALYZER... recall (Beckman Coulter Mishima K.K.)", "product": "Systems/units containing affected software/SQL  BECKMAN COULTER CHEMISTRY ANALYZER AU480  REF / UDI-DI code:  B96692 / 14987666542965  B96693 / 14987666542972  B12183 / 14987666540671    The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.", "reason": "Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message  System Stopped By Fatal Error: DBConnectionError AlarmDB  when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.  This causes a delay in obtaining patient results.", "hazard_level": "Class II", "company": "Beckman Coulter Mishima K.K.", "company_location": "Sunto-Gun, Japan", "date": "2026-08-03", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.", "states": ["AR", "CA", "DE", "FL", "GA", "HI", "IA", "IL", "IN", "KS", "KY", "MN", "MO", "NC", "NM", "NY", "OK", "PA", "SD", "TX", "WI"], "nationwide": true, "quantity": "492 units", "codes": "Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965  Item Number: B96693 UDI-DI code: 14987666542972  Item Number: B12183 UDI-DI code: 14987666540671  Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3332-2026%22", "url": "https://recallledger.net/recalls/device-z-3332-2026-systems-units-containing-affected-software-sql-beckman-coulter-chemis/"}, {"id": "fda-device-z-3329-2026", "source": "FDA", "category": "device", "recall_number": "Z-3329-2026", "title": "Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recall (Olympus Corporation of the Americas)", "product": "Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System", "reason": "While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-27", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Poland.", "states": [], "nationwide": true, "quantity": "543 cables", "codes": "Model Number P580-025, Material Number Material: OS-DPDPC25-G", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3329-2026%22", "url": "https://recallledger.net/recalls/device-z-3329-2026-olympus-tripp-lite-p580-025-25ft-displayport-cable-model-number-p580/"}, {"id": "fda-device-z-3325-2026", "source": "FDA", "category": "device", "recall_number": "Z-3325-2026", "title": "Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)", "product": "Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "419", "codes": "Product/Catalog Number/UDI-DI: S00009/00849436000358, P5-HC/00849436000525", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3325-2026%22", "url": "https://recallledger.net/recalls/device-z-3325-2026-intrapulmonary-percussive-ventilation-ipv-hc-product-number-s00009/"}, {"id": "fda-device-z-3324-2026", "source": "FDA", "category": "device", "recall_number": "Z-3324-2026", "title": "Travel Air recall (Percussionaire Corporation)", "product": "Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "228,596", "codes": "Product Number/UDI-DI: S00055/00849436000242, P5/00849436000501, Instruction Manual: P20106 Rev B", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3324-2026%22", "url": "https://recallledger.net/recalls/device-z-3324-2026-travel-air-product-number-s00055-phasitron-5-product-number-p5-us/"}, {"id": "fda-device-z-3323-2026", "source": "FDA", "category": "device", "recall_number": "Z-3323-2026", "title": "Impulsator recall (Percussionaire Corporation)", "product": "Impulsator, Product Number: S00010,  Phasitron 5, Product Number: P5 used with Instruction Manual", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "228,277", "codes": "Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3323-2026%22", "url": "https://recallledger.net/recalls/device-z-3323-2026-impulsator-product-number-s00010-phasitron-5-product-number-p5-u/"}, {"id": "fda-device-z-3322-2026", "source": "FDA", "category": "device", "recall_number": "Z-3322-2026", "title": "Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)", "product": "Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C;  Phasitron 5, Product Number: P5 used with Instruction Manual", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "229,430", "codes": "Product Number/UDI-DI:  S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648;  P5/00849436000501;  Instruction Manual: P20046 Rev A", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3322-2026%22", "url": "https://recallledger.net/recalls/device-z-3322-2026-intrapulmonary-percussive-ventilation-ipv-2c-product-number-s00002/"}, {"id": "fda-device-z-3321-2026", "source": "FDA", "category": "device", "recall_number": "Z-3321-2026", "title": "Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)", "product": "Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C;  Phasitron 5, Product Number: P5 used with Instruction Manual", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "229,105", "codes": "Product Number/UDI-DI:  S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648;  P5/00849436000501;  Instruction Manual: P20045 Rev B", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3321-2026%22", "url": "https://recallledger.net/recalls/device-z-3321-2026-intrapulmonary-percussive-ventilation-ipv-1c-product-number-s00002/"}, {"id": "fda-device-z-3320-2026", "source": "FDA", "category": "device", "recall_number": "Z-3320-2026", "title": "In-Line Valve recall (Percussionaire Corporation)", "product": "In-Line Valve, Product Number: P5-TEE", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "98,434", "codes": "UDI: 00849436000723", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3320-2026%22", "url": "https://recallledger.net/recalls/device-z-3320-2026-in-line-valve-product-number-p5-tee/"}, {"id": "fda-device-z-3319-2026", "source": "FDA", "category": "device", "recall_number": "Z-3319-2026", "title": "Intrapulmonary Percussive Ventilation recall (Percussionaire Corporation)", "product": "Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065;  Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual", "reason": "Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation", "hazard_level": "Class II", "company": "Percussionaire Corporation", "company_location": "Sandpoint, ID, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "61,858", "codes": "Product Number/UDI-DI:  S00065/00849436000679, 00849436000709; P5-UC/00849436000686 In-Line Valve Instruction Manual: P20174 Rev D", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3319-2026%22", "url": "https://recallledger.net/recalls/device-z-3319-2026-intrapulmonary-percussive-ventilation-ipv-1-product-number-s00065/"}, {"id": "fda-device-z-3318-2026", "source": "FDA", "category": "device", "recall_number": "Z-3318-2026", "title": "Evolution upgrade 1.5T amd Evolution upgrade 3.0T recall (Philips North America)", "product": "Evolution upgrade 1.5T amd Evolution upgrade 3.0T;  Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T);   Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "91", "codes": "1. Model number (REF): 782116 (1.5T); UDI-DI: 00884838099722; Serial Numbers: 41042, 41235, 41287, 41295, 41367, 41505, 41568, 70068, 70093, 70995, 70996, 84370;  2. Model number (REF): 782148 (1.5T); UDI-DI: 00884838108714; Serial Numbers: 41011, 41031, 41110, 41244, 41277, 41334, 41427, 41446, 41464, 41523, 41534, 70425, 70454, 70473, 70622, 70630, 70644, 70769, 70803, 70966, 70983, 84102, 84409, 84560, 84569, 84630, 84825;  3. Model number (REF): 782166 (1.5T); UDI-DI: 00884838115774; Serial Numbers: 41005, 41161, 41485, 41499, 41572, 70155, 70206, 70826, 84048, 84270, 84541;  4. Model number (REF): 782201 (1.5T); UDI-DI: 00884838128552; Serial Numbers: 84018, 84648;  5. Model number (REF): 782117 (3.0T); UDI-DI: 00884838099739; Serial Numbers: 42023, 42024, 42078, 42375, 71348, 85681, 85705;  6. Model number (REF): 782143 (3.0T); UDI-DI: 00884838108660; Serial Numbers: 42069, 42225, 42254, 42318, 42366, 42415, 42440, 71389, 71460, 71595, 71815, 71836, 85649, 85651, 85654, 85682, 85683, 85688, 85690, 85695, 85697, 85699, 85701, 85714;  7. Model number (REF): 782162 (3.0T); UDI-DI: 00884838115736; Serial Numbers: 42184, 42369, 71074, 71403, 71433, 71574, 71740, 85145;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3318-2026%22", "url": "https://recallledger.net/recalls/device-z-3318-2026-evolution-upgrade-1-5t-amd-evolution-upgrade-3-0t-model-number-ref/"}, {"id": "fda-device-z-3317-2026", "source": "FDA", "category": "device", "recall_number": "Z-3317-2026", "title": "Upgrade to MR 7700 recall (Philips North America)", "product": "Upgrade to MR 7700;  Model number (REF): 782130;   Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "30", "codes": "Model number (REF): 782130; UDI-DI: 00884838104402; Serial Numbers: 42002, 42030, 42037, 42066, 42104, 42151, 42163, 42164, 42211, 42219, 42248, 42376, 45001, 45007, 45043, 45044, 45052, 45179, 45236, 45263, 45552, 71060, 71262, 71279, 71406, 71532, 71565, 71580, 71616, 71907;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3317-2026%22", "url": "https://recallledger.net/recalls/device-z-3317-2026-upgrade-to-mr-7700-model-number-ref-782130-software-versions/"}, {"id": "fda-device-z-3316-2026", "source": "FDA", "category": "device", "recall_number": "Z-3316-2026", "title": "Upgrade dStream recall (Philips North America)", "product": "Upgrade dStream;  Model number (REF): 782127;   Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "1", "codes": "Model number (REF): 782127; UDI-DI: 00884838105591; Serial Numbers: 65007;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3316-2026%22", "url": "https://recallledger.net/recalls/device-z-3316-2026-upgrade-dstream-model-number-ref-782127-software-versions-r11/"}, {"id": "fda-device-z-3315-2026", "source": "FDA", "category": "device", "recall_number": "Z-3315-2026", "title": "SmartPath to MR 7700 recall (Philips North America)", "product": "SmartPath to MR 7700;  Model number (REF): 1. 782178, 2. 782207;   Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "5", "codes": "1. Model number (REF): 782178; UDI-DI: 00884838122239; Serial Numbers: 42165, 42189, 71081;  2. Model Number (REF): 782207; UDI-DI: 00884838128576; Serial Numbers: 42055, 42287;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3315-2026%22", "url": "https://recallledger.net/recalls/device-z-3315-2026-smartpath-to-mr-7700-model-number-ref-1-782178-2-782207-sof/"}, {"id": "fda-device-z-3314-2026", "source": "FDA", "category": "device", "recall_number": "Z-3314-2026", "title": "SmartPath to dStream for 1.5T recall (Philips North America)", "product": "SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for  XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "200", "codes": "1. Model number (REF): 781260 (1.5T); UDI-DI: 00884838095076; Serial Numbers: 5479, 5490, 8057, 8118, 8260, 8330, 8392, 8819, 8884, 8954, 10044, 10170, 10236, 11062, 13018, 13029, 13047, 18663, 18872, 20033, 20115, 20164, 20319, 20322, 20413, 21011, 21062, 21133, 21142, 21156, 21278, 21577, 21583, 21621, 21775, 21880, 21969, 22157, 22248, 32049, 32245, 32262, 32286, 32322, 32845, 39024;  2. Model Number (REF): 782112 (1.5T); UDI-DI: 00884838098886; Serial Numbers: 12002, 21205, 21658, 30031, 32378, 32519, 33338;  3. Model Number (REF): 782146 (1.5T); UDI-DI: 00884838108691; Serial Numbers: 8935, 13013, 21202, 30308, 32570, 32634, 32679, 32683, 32750, 33074, 33479, 33611, 33714, 39040;  4. Model Number (REF): 782165 (1.5T); UDI-DI: 00884838115767; Serial Numbers: 21763, 22170, 32402, 32409, 32971, 33379, 33387, 33571, 39075, 72160, 72190;  5. Model Number (REF): 782145 (3.0T); UDI-DI: 00884838108684; Serial Numbers: 17377, 17385, 17435, 24010, 24062, 34256, 34282, 38059, 38118, 38127, 38170, 38251, 38278, 38294, 38295, 38302, 38336, 73002, 74004, 74007, 74030;  6. Model Number (REF): 782164 (3.0T); UDI-DI: 00884838115750; Serial Numbers: 34038, 34254, 34268, 38021, 38046, 38061, 38086, 38090, 38223, 38246, 74020, 74033;  7. Model Number (REF): 781270 (XR and 3.0T); UDI-DI: 00884838095083; Serial Numbers: 17239, 17246, 17264, 17269, 17283, 17299, 17356, 17357, 17369, 17406, 17416, 17425, 17434, 17464, 17468, 17473, 17514, 17544, 17550, 17564, 17565, 17569, 17589, 17590, 23026, 23033, 24006, 24012, 24023, 24066, 24075, 24087, 24090, 24108, 24110, 34107, 34152, 34154, 34233, 35032, 35047, 35054, 35056, 35087, 38001, 38004, 38023, 38071, 38084, 38089, 38120, 38202, 38300;  8. Model Number (REF): 782113 (XR and 3.0T); UDI-DI: 00884838098909; Serial Numbers: 17346, 17439, 24039, 24077, 24146, 34131, 34212, 35045, 35063, 35071, 38075, 38197, 38234, 38291;  9. Model Number (REF): 782129 (XR and 3.0T); UDI-DI: 00884838105805; Serial Numbers: 34055, 38195;  10. Model Number (REF): 782118 (Ingenia Elition X); UDI-DI: 00884838099746; Serial Numbers: 42072, 42098, 42194, 42298, 42301, 42329, 42340, 71019, 71025;  11. Model Number (REF): 782144 (Ingenia Elition X); UDI-DI: 00884838108677; Serial Numbers: 42062, 42105, 42323, 42346, 42363, 71087, 71504;  12. Model Number (REF): 782163 (Ingenia Elition X); UDI-DI: 00884838115743; Serial Numbers: 42299, 42354, 42404, 71390;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3314-2026%22", "url": "https://recallledger.net/recalls/device-z-3314-2026-smartpath-to-dstream-for-1-5t-smartpath-to-dstream-for-3-0t-smartpat/"}, {"id": "fda-device-z-3313-2026", "source": "FDA", "category": "device", "recall_number": "Z-3313-2026", "title": "MR 7700 recall (Philips North America)", "product": "MR 7700;  Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199;  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "107", "codes": "1. Model number (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067;   2. Model Number (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68013, 68014, 68016, 68017, 68018, 68019, 68020, 68021, 68022, 68023, 68024, 68025, 68026, 68028, 68029, 68030, 68031, 68032, 68033, 68034, 68036, 68037, 68041, 68042, 68043, 68047, 68049, 68050;  3. Model Number (REF): 782155; UDI-DI: 00884838115668; Serial Numbers: 94000, 94002, 94004, 94006, 94007, 94008, 94009, 94011, 94012, 94013, 94014, 94015, 94016, 94021, 94023, 94024;  4. Model Number (REF): 782199; UDI-DI: 00884838128439; Serial Numbers: 19300, 19303, 19304, 19309, 19312, 19313;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3313-2026%22", "url": "https://recallledger.net/recalls/device-z-3313-2026-mr-7700-model-number-ref-1-782120-2-782153-3-782155-4-7821/"}, {"id": "fda-device-z-3312-2026", "source": "FDA", "category": "device", "recall_number": "Z-3312-2026", "title": "MR 5300 recall (Philips North America)", "product": "MR 5300;  Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196;  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "131", "codes": "1. Model number (REF): 782110; UDI-DI: 00884838099364; Serial Numbers: 63007, 63027, 63064, 63076, 63097, 63123, 63132, 63137, 63148, 63150, 63160, 63236, 63237, 63238, 63258, 63300, 63302, 63360, 63370, 63394, 63397, 63398, 63445, 63523, 63576, 63599, 63636, 63696, 63735, 63766, 63767, 63774, 63806;   2. Model Number (REF): 782152; UDI-DI: 00884838112841; Serial Numbers: 69000, 69007, 69008, 69012, 69015, 69016, 69017, 69030, 69048, 69067, 69068, 69070, 69071, 69076, 69078, 69089, 69094, 69096, 69097, 69101, 69102, 69110, 69121, 69124, 69126, 69128, 69134, 69135, 69137, 69143, 69150, 69154, 69160, 69161, 69171, 69175, 69180, 69193, 69194, 69198, 69209, 69212, 69238, 69239, 69240, 69241, 69247, 69249, 69250, 69263, 69264, 69265, 69266, 69287, 69289, 69290, 69299, 69300, 69304, 69307, 69309, 69310, 69312, 69316, 69318, 69319, 69320, 69321, 69338, 69342, 69344, 69345, 69366, 69367;  3. Model Number (REF): 782156; UDI-DI: 00884838115675; Serial Numbers: 93000, 93007, 93008, 93018, 93023, 93026, 93028, 93037, 93054, 93073, 93084, 93100, 93101, 93102, 93103, 93104, 93105, 93106;  4. Model Number (REF): 782196; UDI-DI: 00884838128446; Serial Numbers: 54016, 54024, 54036, 54040, 54050, 54054;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3312-2026%22", "url": "https://recallledger.net/recalls/device-z-3312-2026-mr-5300-model-number-ref-1-782110-2-782152-3-782156-4-7821/"}, {"id": "fda-device-z-3311-2026", "source": "FDA", "category": "device", "recall_number": "Z-3311-2026", "title": "Ingenia Elition S and Ingenia Elition X. recall (Philips North America)", "product": "Ingenia Elition S and Ingenia Elition X.;  Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "340", "codes": "1. Model number (REF): 781357 (S); UDI-DI: 00884838088108; Serial Numbers: 46002, 46012, 46013, 46017, 46018, 46020, 46021, 46023, 46025, 46027, 46029, 46036, 46039, 46041, 46042, 46044, 46053, 46054, 46082, 46086, 46092;   2. Model Number (REF): 782106 (S); UDI-DI: 00884838098329; Serial Numbers: 46203, 46204, 46207, 46208, 46209, 46219, 46220, 46225, 46235, 46243, 46249, 46258, 46269, 46270, 46286, 46302, 46315, 46325, 46375;  3. Model Number (REF): 782137 (S); UDI-DI: 00884838108615; Serial Numbers: 64001, 64002, 64003, 64004, 64005, 64014, 64015, 64029, 64032, 64039, 64040, 64041, 64042, 64049, 64050, 64051, 64052;  4. Model Number (REF): 782157 (S); UDI-DI: 00884838115682; Serial Numbers: 8900, 89003;  5. Model Number (REF): 781358 (X); UDI-DI: 00884838088115; Serial Numbers: 45008, 45009, 45010, 45011, 45024, 45026, 45028, 45029, 45032, 45033, 45034, 45035, 45036, 45037, 45040, 45041, 45046, 45048, 45049, 45054, 45055, 45056, 45060, 45062, 45066, 45070, 45072, 45073, 45075, 45076, 45078, 45086, 45087, 45089, 45090, 45091, 45093, 45094, 45096, 45097, 45098, 45099, 45100, 45105, 45108, 45112, 45113, 45115, 45116, 45119, 45120, 45127, 45129, 45132, 45136, 45138, 45140, 45146, 45147, 45148, 45152, 45154, 45156, 45157, 45160, 45162, 45168, 45174, 45181, 45186, 45187, 45189, 45190, 45191, 45194, 45205, 45215, 45231, 45235, 45237, 45243, 45245, 45246, 45250, 45252, 45264, 45272, 45277, 45278, 45290, 45296, 45316, 45317, 45319, 45323, 45328, 45333, 45335, 45340, 45342, 45374, 45379, 45395, 45398, 45399, 45406, 45407, 45414, 45423, 45441;  6. Model Number (REF): 782107 (X); UDI-DI: 00884838098336; Serial Numbers: 45500, 45503, 45506, 45507, 45508, 45509, 45510, 45514, 45519, 45523, 45525, 45530, 45532, 45533, 45534, 45536, 45542, 45545, 45547, 45551, 45560, 45561, 45573, 45574, 45578, 45579, 45589, 45594, 62019, 62024, 62026, 62030, 62031, 62033, 62035, 62037, 62040, 62041, 62048, 62051, 62052, 62056, 62058, 62059, 62061, 62062, 62063, 62065, 62067, 62070, 62071, 62073, 62080, 62081, 62082, 62088, 62092, 62098, 62134, 62136, 62137, 62148, 62151, 62152, 62153, 62159, 62178, 62181, 62182, 62197;  7. Model Number (REF): 782119 (X); UDI-DI: 00884838104129; Serial Number: 66001;  8. Model Number (REF): 782136 (X); UDI-DI: 00884838108608; Serial Numbers: 28500, 28502, 28503, 28504, 28506, 28507, 28509, 28510, 28514, 28515, 28516, 28521, 28524, 28525, 28526, 28527, 28528, 28529, 28532, 28533, 28535, 28536, 28538, 28540, 28542, 28543, 28544, 28546, 28547, 28548, 28549, 28550, 28555, 28558, 28559, 28560, 28563, 28564, 28565, 28566, 28568, 28572, 28573, 28576, 28577, 28579, 28581, 28583, 28585, 28586, 28587, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28604, 28605, 28608, 28611, 28612, 28613, 28614, 28615, 28616, 28618, 28619, 28623, 28625, 28628, 28629, 28630, 28631, 28632, 28635, 28636, 28638;  9. Model Number (REF): 782158 (X); UDI-DI: 00884838115699; Serial Numbers: 90001, 90002, 90004, 90006, 90007, 90010, 90011, 90015, 90016, 90017, 90018, 90023, 90024, 90027, 90036;  10. Model Number (REF): 782198 (X); UDI-DI: 00884838128460; Serial Numbers: 57003, 57004, 57005, 57009;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3311-2026%22", "url": "https://recallledger.net/recalls/device-z-3311-2026-ingenia-elition-s-and-ingenia-elition-x-model-number-ref-1-7813/"}, {"id": "fda-device-z-3310-2026", "source": "FDA", "category": "device", "recall_number": "Z-3310-2026", "title": "Ingenia Ambition S and Ingenia Ambition X. recall (Philips North America)", "product": "Ingenia Ambition S and Ingenia Ambition X.;  Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced  MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping  nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "422", "codes": "1. Model number (REF): 781359 (S); UDI-DI: 00884838090057; Serial Numbers: 48010, 48023, 48028, 48047, 48122, 48160, 48173, 48180, 48196, 48286;   2. Model Number (REF): 782108 (S); UDI-DI: 00884838098343; Serial Numbers: 48507, 48510, 48530, 48548, 48554, 48576, 48577, 48580, 48586, 48607, 48616, 48620, 48653, 48686, 48688, 48726, 48746, 48778, 48818, 48831, 48847, 48872, 48878, 48888, 48893, 48896, 48897, 48917, 48922, 48931;  3. Model Number (REF): 782139 (S); UDI-DI: 00884838108639; Serial Numbers: 29016, 29017, 29018, 29020, 29026, 29029, 29031, 29041, 29054, 29063, 29069, 29071, 29076, 29078, 29079, 29086, 29104, 29115, 29118, 29144, 29145, 29150, 29160, 29164, 29169;  4. Model Number (REF): 782159 (S); UDI-DI: 00884838115705; Serial Numbers: 91007, 91027, 91031, 91038, 91043, 91051;  5. Model Number (REF): 782194 (S); UDI-DI: 00884838128477; Serial Numbers: 22401, 22410;  6. Model Number (REF): 781356 (X); UDI-DI: 00884838090040; Serial Numbers: 47004, 47006, 47011, 47012, 47013, 47014, 47018, 47020, 47026, 47027, 47028, 47029, 47037, 47038, 47039, 47043, 47048, 47051, 47057, 47059, 47063, 47067, 47068, 47070, 47092, 47094, 47098, 47099, 47177, 47187, 47188, 47189, 47195, 47197, 47199, 47203, 47206, 47211, 47215, 47221, 47222, 47233, 47237, 47242, 47248, 47253, 47260, 47268, 47270, 47271, 47274, 47276, 47278, 47279, 47281, 47282, 47289, 47290, 47292, 47294, 47297, 47303, 47305, 47313, 47314, 47322, 47344, 47347, 47348, 47351, 47353, 47356, 47371;  7. Model Number (REF): 782109 (X); UDI-DI: 00884838098350; Serial Numbers: 47502, 47503, 47505, 47507, 47508, 47512, 47517, 47518, 47519, 47520, 47534, 47535, 47541, 47542, 47543, 47549, 47552, 47555, 47558, 47562, 47567, 47568, 47569, 47570, 47572, 47580, 47588, 47589, 47590, 47594, 47595, 47596, 47598, 47599, 47608, 47610, 47612, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47648, 47651, 47653, 47654, 47661, 47662, 47663, 47668, 47669, 47671, 47674, 47681, 47682, 47687, 47692, 47693, 47694, 47699, 47700, 47702, 47703, 47706, 47709, 47710, 47711, 47714, 47717, 47718, 47719, 47721, 47722, 47723, 47724, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47752, 47760, 47761, 47762, 47766, 47767, 47771, 47778, 47779, 47780, 47781, 47788, 47789, 47795, 47796, 47797, 47800, 47807, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47823, 47824, 47826, 47834, 47839, 47843, 47848, 47849, 47851, 47862, 47863, 47864, 47874, 47876, 47881, 47882, 47884, 47885, 47886, 47887, 47891, 47892, 47893, 47894, 47895, 47899, 47932, 47944, 47962;  8. Model Number (REF): 782138 (X); UDI-DI: 00884838108622; Serial Numbers: 49000, 49001, 49004, 49014, 49015, 49019, 49020, 49022, 49025, 49027, 49028, 49033, 49037, 49038, 49041, 49043, 49045, 49047, 49048, 49049, 49053, 49056, 49057, 49058, 49062, 49063, 49071, 49072, 49075, 49097, 49099, 49100, 49102, 49106, 49109, 49111, 49113, 49124, 49128, 49129, 49136, 49145, 49153, 49154, 49155, 49156, 49158, 49161, 49162, 49163, 49164, 49165, 49168, 49170, 49171, 49172, 49174, 49177, 49178, 49180, 49183, 49189, 49190, 49194, 49196, 49197, 49203, 49206, 49207, 49210, 49212, 49215, 49216, 49217, 49219, 49220, 49221, 49222, 49223, 49228, 49229, 49230, 49231, 49233, 49237, 49238, 49243, 49246, 49247, 49250, 49251, 49253, 49257, 49261, 49265, 49268, 49269, 49270, 49272, 49282, 49287, 49288, 49290, 49291;  9. Model Number (REF): 782160 (X); UDI-DI: 00884838115712; Serial Numbers: 92000, 92003, 92006, 92016, 92022, 92024, 92028, 92029, 92031, 92035, 92036, 92039, 92042, 92046, 92053, 92056, 92067, 92068, 92069, 92070, 92072, 92084, 92097;  10. Model Number (REF): 782195 (X); UDI-DI: 00884838128484; Serial Numbers: 55004, 55005, 55011, 55012, 55018, 55019, 55021, 55024, 55032;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3310-2026%22", "url": "https://recallledger.net/recalls/device-z-3310-2026-ingenia-ambition-s-and-ingenia-ambition-x-model-number-ref-1-78/"}, {"id": "fda-device-z-3309-2026", "source": "FDA", "category": "device", "recall_number": "Z-3309-2026", "title": "Ingenia 3.0T and 3.0T CX recall (Philips North America)", "product": "Ingenia 3.0T and 3.0T CX;  Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced  MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping  nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "243", "codes": "1. Model number (REF): 1. 781342 (3.0T); UDI-DI: 00884838055339; Serial Numbers: 71001, 71002, 71008, 71031, 71038, 71051, 71061, 71072, 71084, 71088, 71089, 71095, 71101, 71154, 71163, 71164, 71166, 71184, 71185, 71193, 71210, 71231, 71269, 71271, 71288, 71290, 71297, 71301, 71303, 71309, 71311, 71312, 71322, 71335, 71336, 71340, 71341, 71344, 71355, 71375, 71385, 71393, 71412, 71413, 71420, 71422, 71427, 71438, 71441, 71443, 71445, 71446, 71449, 71450, 71459, 71462, 71463, 71475, 71486, 71487, 71489, 71491, 71513, 71521, 71528, 71556, 71558, 71562, 71589, 71604, 71607, 71612, 71615, 71619, 71620, 71639, 71641, 71646, 71665, 71673, 71688, 71697, 71704, 71710, 71715, 71729, 71730, 71739, 71754, 71756, 71757, 71759, 71813, 71817, 71828, 71831, 71841, 71849, 71850, 71853, 71862, 71885, 71896, 71921, 71923, 71954, 71959, 71960, 71962, 71963, 71964, 71986, 71992, 85006, 85020, 85032, 85038, 85046, 85066, 85068, 85076, 85078, 85085, 85087, 85091, 85092, 85102, 85126, 85148, 85150, 85154, 85191, 85201, 85216, 85245, 85279, 85377;   2. Model Number (REF): 781377 (3.0T); UDI-DI: 00884838009813; Serial Numbers: 42012, 42014, 42015, 42017, 42033, 42036, 42048, 42059, 42088, 42092, 42109, 42125, 42126, 42127, 42146, 42169, 42196, 42198, 42206, 42210, 42218, 42220, 42224, 42228, 42234, 42238, 42247, 42258, 42265, 42271, 42282, 42288, 42293, 42305, 42307, 42321, 42322, 42330, 42342, 42352, 42353, 42359, 42360, 42386, 42389, 42396, 42403, 42409, 42412, 42416, 42425;  3. Model Number (REF): 782103 (3.0T); UDI-DI: 00884838098299; Serial Numbers: 85646, 85652, 85679, 85686, 85708, 85723, 85758, 85759, 85762;  4. Model Number (REF): 781271 (3.0T CX); UDI-DI: 00884838068452; Serial Numbers: 78008, 78009, 78011, 78012, 78017, 78018, 78027, 78028, 78033, 78035, 78036, 78039, 78040, 78042, 78045, 78053, 78060, 78062, 78063, 78067, 78068, 78070, 78095, 78100, 78103, 78112, 78113, 78115, 78122, 78145, 78147, 78148, 78155, 78166, 78167, 78186, 78195, 78201, 78202, 78208, 78215, 78217, 78229, 78277, 78286, 78287;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3309-2026%22", "url": "https://recallledger.net/recalls/device-z-3309-2026-ingenia-3-0t-and-3-0t-cx-model-number-ref-1-781342-3-0t-2-78/"}, {"id": "fda-device-z-3308-2026", "source": "FDA", "category": "device", "recall_number": "Z-3308-2026", "title": "Ingenia 1.5T recall (Philips North America)", "product": "Ingenia 1.5T, 1.5T CX, and 1.5T S;  Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T),  5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced  MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping  nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "216", "codes": "1. Model number (REF): 1. 781315 (1.5T); UDI-DI: 00884838099715; Serial Numbers: 61005, 61007, 61014, 61033, 61036, 61047, 61056, 61057, 61076, 61087, 61088, 61105, 61116;   2. Model Number (REF): 781341 (1.5T); UDI-DI: 00884838055322; Serial Numbers: 70042, 70051, 70056, 70062, 70203, 70227, 70229, 70249, 70257, 70262, 70285, 70300, 70311, 70383, 70424, 70432, 70438, 70445, 70453, 70460, 70472, 70588, 70598, 70619, 70638, 70642, 70645, 70647, 70708, 70717, 70724, 70728, 70743, 70750, 70751, 70787, 70801, 70821, 70825, 70836, 70846, 70875, 70876, 70886, 70889, 70896, 70904, 70920, 70957, 70961, 70967, 70970, 70979, 70988, 84049, 84076, 84079, 84080, 84141, 84162, 84170, 84173, 84186, 84205, 84212, 84219, 84233, 84250, 84254, 84266, 84267, 84281, 84289, 84329, 84332, 84335, 84343, 84359, 84360, 84368, 84379, 84388, 84392, 84403, 84415, 84431, 84433, 84436, 84450, 84451, 84467, 84476, 84491, 84500, 84510, 84539, 84549, 84555, 84556, 84568, 84596, 84634, 84635, 84641, 84642, 84652, 84660, 84708, 84713, 84714, 84721, 84741, 84745, 84768, 84804, 84839, 84840, 84853, 84858, 84867, 84869, 84893, 84904, 84908, 84978, 84987, 87068, 87076, 87092, 87196, 87197, 87259;  3. Model Number (REF): 781396 (1.5T); UDI-DI: 00884838009820; Serial Numbers: 41000, 41001, 41021, 41034, 41046, 41056, 41061, 41091, 41116, 41145, 41194, 41231, 41249, 41253, 41254, 41255, 41352, 41354, 41356, 41370, 41400, 41408, 41422, 41428, 41456, 41475, 41492, 41513, 41515, 41548;  4. Model Number (REF): 782115 (1.5T); UDI-DI: 00884838099043; Serial Numbers: 61186, 61191, 61196, 61219, 61228, 61236, 61238, 61272, 61276, 61317, 61382, 61383, 61384, 61386, 61387, 61388, 61390, 61396, 61399, 61401, 61402, 61408, 61411, 61418, 61430;  5. Model Number (REF): 782140 (1.5T); UDI-DI: 00884838108646; Serial Numbers: 45608, 45609;  6. Model Number (REF): 781262 (1.5T CX); UDI-DI: 00884838068445; Serial Numbers: 77047, 77058, 77059, 77120, 77143, 77151, 77158, 77161, 77179, 77180, 77182;  7. Model Number (REF): 781347 (1.5T S); UDI-DI: 00884838068421; Serial Numbers: 81027, 81033, 81145;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3308-2026%22", "url": "https://recallledger.net/recalls/device-z-3308-2026-ingenia-1-5t-1-5t-cx-and-1-5t-s-model-number-ref-1-781315-1-5/"}, {"id": "fda-device-z-3307-2026", "source": "FDA", "category": "device", "recall_number": "Z-3307-2026", "title": "Ingenia Blue Seal SE and Blue Seal XE recall (Philips North America)", "product": "Ingenia Blue Seal SE and Blue Seal XE;  Model number (REF): 1. 782185 (SE), 2. 782192 (XE);  Software Versions: R11, R12 and R13;", "reason": "When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced  MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR  DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping  nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for  reconstruction.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2026-08-28", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam.", "states": ["GA"], "nationwide": true, "quantity": "6", "codes": "1. Model number (REF): 1. 782185 (SE); UDI-DI: 00884838125698; Serial Number: 53002;   2. Model Number (REF): 782192 (XE); UDI-DI: 00884838128422; Serial Numbers: 56000, 56001, 56005, 56010, 56012;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3307-2026%22", "url": "https://recallledger.net/recalls/device-z-3307-2026-ingenia-blue-seal-se-and-blue-seal-xe-model-number-ref-1-782185/"}, {"id": "fda-device-z-3305-2026", "source": "FDA", "category": "device", "recall_number": "Z-3305-2026", "title": "Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam recall (Merit Medical Systems, Inc.)", "product": "Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF:   S420GH/EUA, S620GH/EUA;    Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB;    Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA", "reason": "Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2026-08-10", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of CA, GA and the countries of  France, Ireland, Canada, Switzerland.", "states": ["CA", "GA"], "nationwide": true, "quantity": "104", "codes": "S420GH/EUA/00884450116715/X3467294-1, S620GH/EUA/00884450109519/X3472987-1, S820GH/CAB/00884450364154/X3472923-A, S1020GH/C/00884450403136/X3482321-5, S1020GH/EUA/00884450109519/X3482321-1,", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3305-2026%22", "url": "https://recallledger.net/recalls/device-z-3305-2026-embosphere-500-700-micrometer-2-ml-syringe-sterile-steam-ref-s420g/"}, {"id": "fda-device-z-3304-2026", "source": "FDA", "category": "device", "recall_number": "Z-3304-2026", "title": "PALACOS MV pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.     Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).  Component: N/A", "reason": "Potential for monomer liquid leakage.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": true, "quantity": "", "codes": "Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3304-2026%22", "url": "https://recallledger.net/recalls/device-z-3304-2026-palacos-mv-pro-40-palacos-mv-pro-80-model-catalog-number-5150633-5/"}, {"id": "fda-device-z-3303-2026", "source": "FDA", "category": "device", "recall_number": "Z-3303-2026", "title": "PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.    Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).  Component: N/A", "reason": "Potential for monomer liquid leakage.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": true, "quantity": "20,523 units", "codes": "Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3303-2026%22", "url": "https://recallledger.net/recalls/device-z-3303-2026-palacos-mv-g-pro-40-palacos-mv-g-pro-80-model-catalog-number-508129/"}, {"id": "fda-device-z-3302-2026", "source": "FDA", "category": "device", "recall_number": "Z-3302-2026", "title": "PALACOS R+G pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.     Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).", "reason": "Potential for monomer liquid leakage.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": true, "quantity": "59,660 units", "codes": "Lot Code: UDI-DI: 04260102136182; 04260102136212. All Batch Numbers. All Lot Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3302-2026%22", "url": "https://recallledger.net/recalls/device-z-3302-2026-palacos-r-g-pro-40-palacos-r-g-pro-80-model-catalog-number-5081288/"}, {"id": "fda-device-z-3301-2026", "source": "FDA", "category": "device", "recall_number": "Z-3301-2026", "title": "PALACOS R pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.    Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).", "reason": "Potential for monomer liquid leakage.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": true, "quantity": "33,727 units", "codes": "UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3301-2026%22", "url": "https://recallledger.net/recalls/device-z-3301-2026-palacos-r-pro-40-palacos-r-pro-80-model-catalog-numbers-5081286-50/"}, {"id": "fda-device-z-3300-2026", "source": "FDA", "category": "device", "recall_number": "Z-3300-2026", "title": "Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A. recall (Olympus Corporation of the Americas)", "product": "Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.", "reason": "There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "International distribution to the country of Japan.", "states": [], "nationwide": false, "quantity": "50 units", "codes": "Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3300-2026%22", "url": "https://recallledger.net/recalls/device-z-3300-2026-olympus-m3-gold-autoclavable-lateral-telescope-70-model-number-m3-70/"}, {"id": "fda-device-z-3299-2026", "source": "FDA", "category": "device", "recall_number": "Z-3299-2026", "title": "Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A. recall (Olympus Corporation of the Americas)", "product": "Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.", "reason": "There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "International distribution to the country of Japan.", "states": [], "nationwide": false, "quantity": "72 units", "codes": "Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3299-2026%22", "url": "https://recallledger.net/recalls/device-z-3299-2026-olympus-m3-gold-autoclavable-foroblique-telescope-30-model-number-m3/"}, {"id": "fda-device-z-3298-2026", "source": "FDA", "category": "device", "recall_number": "Z-3298-2026", "title": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT, LAVH                     , Catalog Number: PB63VHSTC", "reason": "The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "states": ["CA", "IL", "KY", "MO", "NC", "NY", "OH", "TX"], "nationwide": true, "quantity": "22 kits", "codes": "1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2                      ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3298-2026%22", "url": "https://recallledger.net/recalls/device-z-3298-2026-presource-packs-containing-stryker-strykeflow-ps-and-ahto-tube-sets/"}, {"id": "fda-device-z-3297-2026", "source": "FDA", "category": "device", "recall_number": "Z-3297-2026", "title": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT, GYN LAPAROSCOPY NEW HAN  , Catalog Number: PB23GLNLAC;   2) KIT, GYN LAPAROSCOPY NEW HAN  , Catalog Number: PB23GLNLA1;   3) KIT, GYN LAPAROSCOPY NEW HAN  , Catalog Number: PB23GLNLA2;   4) KIT, GYN LAPAROSCOPY NEW HAN  , Catalog Number: PB23GLNLA3;   5) KIT, GYN LAPAROSCOPY NEW HAN  , Catalog Number: PB23GLNLA4;   6) KIT, GYN ROBOTIC NEW HAN      , Catalog Number: PB23GRNLD;   7) KIT, GYN ROBOTIC NEW HAN      , Catalog Number: PB23GRNLE;   8) KIT, GYN ROBOTIC NEW HAN      , Catalog Number: PB23GRNL5;   9) KIT, GYN ROBOTIC NEW HAN      , Catalog Number: PB23GRNL6;   10) MVHS GU GYN ROBOT PACK        , Catalog Number: SOTDKGREFB", "reason": "The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "states": ["CA", "IL", "KY", "MO", "NC", "NY", "OH", "TX"], "nationwide": true, "quantity": "2957 kits", "codes": "1) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24317FG2                      ; 2) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24347FG2                      ; 3) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24355FG2                      ; 4) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25069FG2                      ; 5) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25014FG2                      ; 6) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25029FG2                      ; 7) PB23GLNLA1, UDI-DI: 10197106809969(each), 50197106809967(case), Lot Number: 20                            ; 8) PB23GLNLA2, UDI-DI: 10198956053328(each), 50198956053326(case), Lot Number: 24317FG2                      ; 9) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24309FG2                      ; 10) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24317FG2                      ; 11) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24325FG2                      ; 12) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24317FG2                      ; 13) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24325FG2                      ; 14) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2                      ; 15) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24355FG2                      ; 16) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2                      ; 17) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2                      ; 18) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2                      ; 19) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25029FG2                      ; 20) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25045FG2                      ; 21) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2                      ; 22) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25065FG2                      ; 23) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25062FG2                      ; 24) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25085FG2                      ; 25) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25097FG2                      ; 26) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25101FG2                      ; 27) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25148FG2                      ; 28) PB23GRNLE, UDI-DI: 10198956320178(each), 50198956320176(case), Lot Number: 25217FG2                      ; 29) PB23GRNL5, UDI-DI: 10198956050419(each), 50198956050417(case), Lot Number: 24325FG2                      ; 30) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24299FG2                      ; 31) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24317FG2                      ; 32) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24325FG2                      ; 33) SOTDKGREFB, UDI-DI: 10198956112766(each), 50198956112764(case), Lot Number: 25154FG2", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3297-2026%22", "url": "https://recallledger.net/recalls/device-z-3297-2026-presource-packs-containing-stryker-strykeflow-ps-and-ahto-tube-sets/"}, {"id": "fda-device-z-3296-2026", "source": "FDA", "category": "device", "recall_number": "Z-3296-2026", "title": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT,GU DAVINCI                , Catalog Number: PGVMDVBWU;   2) KIT,GU DAVINCI                , Catalog Number: PGVMDVBWV;   3) KIT,GU DAVINCI                , Catalog Number: PGVMDVB26;   4) KIT,GU DAVINCI                , Catalog Number: PGVMDVB27;   5) KIT,GU DAVINCI                , Catalog Number: PGVMDVB28;   6) KIT,GU DAVINCI                , Catalog Number: PGVMDVB29;   7) COLORECTAL PACK               , Catalog Number: SBA73CLKFD;   8) COLORECTAL PACK               , Catalog Number: SBA73CLK26", "reason": "The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "states": ["CA", "IL", "KY", "MO", "NC", "NY", "OH", "TX"], "nationwide": true, "quantity": "344 kits", "codes": "1) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2                      ; 2) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24353FG2                      ; 3) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2                      ; 4) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2                      ; 5) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25045FG2                      ; 6) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2                      ; 7) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 24353FG2                      ; 8) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25101FG2                      ; 9) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25148FG2                      ; 10) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25217FG2                      ; 11) PGVMDVB26, UDI-DI: 10198956007796(each), 50198956007794(case), Lot Number: 24309FG2                      ; 12) PGVMDVB27, UDI-DI: 10198956054714(each), 50198956054712(case), Lot Number: 24325FG2                      ; 13) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24317FG2                      ; 14) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24325FG2                      ; 15) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24317FG2                      ; 16) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24348FG2                      ; 17) SBA73CLKFD, UDI-DI: 10197106633960(each), 50197106633968(case), Lot Number: 25055FG2                      ; 18) SBA73CLK26, UDI-DI: 10198956029828(each), 50198956029826(case), Lot Number: 24309FG2", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3296-2026%22", "url": "https://recallledger.net/recalls/device-z-3296-2026-presource-packs-containing-stryker-strykeflow-ps-and-ahto-tube-sets/"}, {"id": "fda-device-z-3295-2026", "source": "FDA", "category": "device", "recall_number": "Z-3295-2026", "title": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:  1) KIT, LAP CHOLE                , Catalog Number: PGCGLCBAC;   2) KIT, LAP CHOLE                , Catalog Number: PGCGLCBAD;   3) KIT, LAP CHOLE                , Catalog Number: PGCGLCBAE;   4) KIT, LAP CHOLE                , Catalog Number: PGCGLCB11;   5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5;   6) HMC ROBOTIC PACK              , Catalog Number: SBA23RBHNG;   7) HMC ROBOTIC PACK              , Catalog Number: SBA23RBHNH;   8) ENS ENDOCHOLEYCYSTECTOMIE 4   , Catalog Number: SBA30EDCLB;   9) LAP CHOLE PACK                , Catalog Number: SLC37LCJOB;   10) LAP CHOLE PACK                , Catalog Number: SLC37LCJ21;   11) LAP CHOLE PACK                , Catalog Number: SLC37LCJ22;   12) PACK GYNE ROBOTIC             , Catalog Number: SMA30RBHSA", "reason": "The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.", "states": ["CA", "IL", "KY", "MO", "NC", "NY", "OH", "TX"], "nationwide": true, "quantity": "3677 kits", "codes": "1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2                      ; 2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2                      ; 3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2                      ; 4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2                      ; 5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2                      ; 6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2                      ; 7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Lot Number: 25217FG2                      ; 8) PGCGLCB11, UDI-DI: 10198956116177(each), 50198956116175(case), Lot Number: 24355FG2                      ; 9) PV63CMST5, UDI-DI: 10198956526204(each), 50198956526202(case), Lot Number: 25148FG2                      ; 10) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2                      ; 11) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24325FG2                      ; 12) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2                      ; 13) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25029FG2                      ; 14) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2                      ; 15) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25045FG2                      ; 16) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2                      ; 17) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2                      ; 18) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25085FG2                      ; 19) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: 25217FG2                      ; 20) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25217FG2                      ; 21) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25216FG2                      ; 22) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25274FG2                      ; 23) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24325FG2                      ; 24) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24309FG2                      ; 25) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2                      ; 26) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24348FG2                      ; 27) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2                      ; 28) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2                      ; 29) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2                      ; 30) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2                      ; 31) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2                      ; 32) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2                      ; 33) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2                      ; 34) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2                      ; 35) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2                      ; 36) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2                      ; 37) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 38) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 39) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 40) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2                      ; 41) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 42) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2                      ; 43) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25069FG2                      ; 44) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2                      ; 45) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25161FG2                      ; 46) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 47) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25101FG2                      ; 48) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25121FG2                      ; 49) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2                      ; 50) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24353FG2                      ; 51) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2                      ; 52) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2                      ; 53) SLC37LCJ21, UDI-DI: 10198956035850(each), 50198956035858(case), Lot Number: 24317FG2                      ; 54) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24317FG2                      ; 55) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24348FG2                      ; 56) SLC37LCJ22, UDI-DI: 10198956109094(each), 50198956109092(case), Lot Number: 24353FG2                      ; 57) SMA30RBHSA, UDI-DI: 10198956437067(each), 50198956437065(case), Lot Number: 25274FG2", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3295-2026%22", "url": "https://recallledger.net/recalls/device-z-3295-2026-presource-packs-containing-stryker-strykeflow-ps-and-ahto-tube-sets/"}, {"id": "fda-device-z-3294-2026", "source": "FDA", "category": "device", "recall_number": "Z-3294-2026", "title": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary... recall (American Contract Systems Inc)", "product": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    ABDOMINAL HYSTERECTOMY - 205989\t  \tModel No. MHAH55AM  \t  LAVH-LAP COLON\t  \tModel No. SPLL54U  \t  VAG HYST PACK\t  \tModel No. SPVH62P", "reason": "Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).", "hazard_level": "Class II", "company": "American Contract Systems Inc", "company_location": "Tiffin, OH, United States", "date": "2026-08-10", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.", "states": ["IA", "MN", "SD", "WI"], "nationwide": true, "quantity": "1,804 kits total", "codes": "MHAH55AM    UDI-DI 191072236487    Lots 42-8529911   42-8649211   42-8687711   42-8797811   42-8857011   42-8869711    SPLL54U    UDI-DI 191072239181    Lots 07-2516111   07-2528611   07-2545611   07-2547911   07-2561411    SPVH62P    UDI-DI 191072238771    Lots 07-2544611   12-7436711", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3294-2026%22", "url": "https://recallledger.net/recalls/device-z-3294-2026-medical-convenience-kits-containing-bd-cliniclean-pericare-wipes-withi/"}, {"id": "fda-device-z-3293-2026", "source": "FDA", "category": "device", "recall_number": "Z-3293-2026", "title": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary... recall (American Contract Systems Inc)", "product": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    CARDIAC HEART BUNDLE NS\t  \tModel No. LMCH99P    OPEN HEART 2 RCH¿ 0248495\t  \tModel No. RCOH62C", "reason": "Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).", "hazard_level": "Class II", "company": "American Contract Systems Inc", "company_location": "Tiffin, OH, United States", "date": "2026-08-10", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.", "states": ["IA", "MN", "SD", "WI"], "nationwide": true, "quantity": "1,804 kits total", "codes": "LMCH99P    UDI-DI 191072228147    Lots 42-8533511   42-8669111   42-8763811   42-8811311   42-8825411   42-8869411    RCOH62C    UDI-DI 191072230942    Lots 42-8504411   42-8561511   42-8668211   42-8737811   42-8797911   42-8862511", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3293-2026%22", "url": "https://recallledger.net/recalls/device-z-3293-2026-medical-convenience-kits-containing-bd-cliniclean-pericare-wipes-withi/"}, {"id": "fda-device-z-3292-2026", "source": "FDA", "category": "device", "recall_number": "Z-3292-2026", "title": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary... recall (American Contract Systems Inc)", "product": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays    ROBOTIC PACK - 242561  Model No. MHRB88AO", "reason": "Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).", "hazard_level": "Class II", "company": "American Contract Systems Inc", "company_location": "Tiffin, OH, United States", "date": "2026-08-10", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.", "states": ["IA", "MN", "SD", "WI"], "nationwide": true, "quantity": "1,804 kits total", "codes": "UDI-DI 191072236531   Lots 42-8513411  42-8580011  42-8663211  42-8775711  42-8801311  42-8840611  42-8865911", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3292-2026%22", "url": "https://recallledger.net/recalls/device-z-3292-2026-medical-convenience-kits-containing-bd-cliniclean-pericare-wipes-withi/"}, {"id": "fda-device-z-3291-2026", "source": "FDA", "category": "device", "recall_number": "Z-3291-2026", "title": "Brand Name: Opportunity Pro  Product Name: Opportunity Pro  Model/Catalog Number: 72-50800 recall (American Nitrile Operations Llc)", "product": "Brand Name: Opportunity Pro  Product Name: Opportunity Pro  Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804  Product Description: Blue Nitrile patient examination glove", "reason": "Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.", "hazard_level": "Class II", "company": "American Nitrile Operations Llc", "company_location": "Grove City, OH, United States", "date": "2026-08-14", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "17,481,000", "codes": "Item No. 72-RM50800  UDI-DI 818634025487 Lots AO01519   Item No. 72-RM50801  UDI-DI 818634025401 Lots AO01518   AO01564   Item No. 72-RM50802  UDI-DI 818634025418 Lots AO01517   AO01531   AO01530   AO01568   Item No. 72-RM50803  UDI-DI 818634025425 Lots AO01529   AO01567   AO01593   AO01594   Item No. 72-RM50804  UDI-DI 818634025432 Lots AO01222   AO01528   AO01566  Alternate lots AN250310948, AN250310947, AN250310945, AN250311327", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3291-2026%22", "url": "https://recallledger.net/recalls/device-z-3291-2026-brand-name-opportunity-pro-product-name-opportunity-pro-model-cata/"}, {"id": "fda-device-z-3290-2026", "source": "FDA", "category": "device", "recall_number": "Z-3290-2026", "title": "Brand Name: Opportunity Flex  Product Name: Opportunity Flex  Model/Catalog Number:... recall (American Nitrile Operations Llc)", "product": "Brand Name: Opportunity Flex  Product Name: Opportunity Flex  Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904  Product Description: Blue Nitrile Patient examination gloves", "reason": "Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.", "hazard_level": "Class II", "company": "American Nitrile Operations Llc", "company_location": "Grove City, OH, United States", "date": "2026-08-14", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "36,793,000", "codes": "Item No. 72-RM50900  UDI-DI 818634025517 Lots AO01292   AO01356   AO01430   AO01457   Item No. 72-RM50901  UDI-DI 818634025449 Lots AO01357   AO01431   AO01458   Item No. 72-RM50902  UDI-DI 818634025456 Lots AO01274   AO01351   AO01355   AO01426   AO01427   AO01429   AO01448   AO01456   AO01377   AO01384  Alternate lots  AN250511407, AN250211237, AN250411331, AN250211252, AN250211236, AN250211237, AN250511407  Item No. 72-RM50903  UDI-DI 818634025463 Lots AO01309   AO01346   AO01353   AO01385   AO01396   AO01425  Alternate lot AN250511332  Item No. 72-RM50904  UDI-DI 818634025470 Lots AO01310   AO01339   AO01352   AO01354   AO01386   AO01408  Alternate lots  AN250511409, AN250511333", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3290-2026%22", "url": "https://recallledger.net/recalls/device-z-3290-2026-brand-name-opportunity-flex-product-name-opportunity-flex-model-ca/"}, {"id": "fda-device-z-3289-2026", "source": "FDA", "category": "device", "recall_number": "Z-3289-2026", "title": "Brand Name: Performance Pro  Product Name: Performance Pro  Model/Catalog Number:... recall (American Nitrile Operations Llc)", "product": "Brand Name: Performance Pro  Product Name: Performance Pro  Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604  Product Description: Blue Nitrile Patient examination gloves", "reason": "Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.", "hazard_level": "Class II", "company": "American Nitrile Operations Llc", "company_location": "Grove City, OH, United States", "date": "2026-08-14", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "99,724,000", "codes": "Item No. 72-RM50601 UDI-DI 818634025562 Lots  AO01306 AO01347 AO01358 AO01381 AO01407 AO01446 AO01466 AO01476 AO01500 AO01513 AO01535 AO01536 AO01551 AO01631 AO01584 AO01634 Alternate Lot  AN250511319  Item No. 72-RM50602 UDI-DI 818634025579 Lots AO01307 AO01348 AO01359 AO01359 AO01379 AO01388 AO01398 AO01410 AO01452 AO01467 AO01477 AO01501 AO01514 AO01533 AO01534 AO01552 AO01582 AO01667 AO01525 AO01532 AO01563 AO01585 AO01668 Alternate Lots  AN250511396 AN250511396 AN250511396  Item No. 72-RM50603 UDI-DI 818634025555 Lots AO01304 AO01313 AO01364 AO01378 AO01387 AO01395 AO01399 AO01405 AO01411 AO01424 AO01432 AO01444 AO01453 AO01454 AO01468 AO01469 AO01479 AO01480 AO01504 AO01515 AO01635   Item No. 72-RM50604 UDI-DI 818634025548 Lots AO01270 AO01365 AO01380 AO01400 AO01433 AO01455 AO01481 AO01503 AO01553 Alternate lots AN250411247, AN250511398, AN250511322", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3289-2026%22", "url": "https://recallledger.net/recalls/device-z-3289-2026-brand-name-performance-pro-product-name-performance-pro-model-cata/"}, {"id": "fda-device-z-3288-2026", "source": "FDA", "category": "device", "recall_number": "Z-3288-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model: uMI 780", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "1", "codes": "UDI-DI: 06971576832033.  Serial Number/Software: 300098/R001. 19.0.1812568", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3288-2026%22", "url": "https://recallledger.net/recalls/device-z-3288-2026-positron-emission-tomography-and-computed-tomography-system-model-um/"}, {"id": "fda-device-z-3287-2026", "source": "FDA", "category": "device", "recall_number": "Z-3287-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "6", "codes": "UDI-DI: 06971576832255. Serial Number/Software:  11MI510005/R003.2.0.1872339,  20MI510001/R003.2.0.1872339,  20MI510002/R003.2.0.1872339,  20MI510003/R003.2.0.1872339,  20MI510004/R003.2.0.1872339,  20MI510005/R003.2.0.1872339", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3287-2026%22", "url": "https://recallledger.net/recalls/device-z-3287-2026-positron-emission-tomography-and-computed-tomography-system-model-um/"}, {"id": "fda-device-z-3286-2026", "source": "FDA", "category": "device", "recall_number": "Z-3286-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model:  uMI Panvivo with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "3", "codes": "UDI-DI: 06971576832231. Serial Number/Software:  11MI500004/R002.4.0.1872339,  11MI500005/R002.4.0.1872339,  11MI500006/R002.4.0.1872339", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3286-2026%22", "url": "https://recallledger.net/recalls/device-z-3286-2026-positron-emission-tomography-and-computed-tomography-system-model-u/"}, {"id": "fda-device-z-3285-2026", "source": "FDA", "category": "device", "recall_number": "Z-3285-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "3", "codes": "UDI-DI: 06971576832187. Serial Number:  11MIP00007/R001.17.5.1785268, 11MIP00009/R001.18.2.1967222, 11MIP00010/R001.18.2.1967222", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3285-2026%22", "url": "https://recallledger.net/recalls/device-z-3285-2026-positron-emission-tomography-and-computed-tomography-system-model-um/"}, {"id": "fda-device-z-3284-2026", "source": "FDA", "category": "device", "recall_number": "Z-3284-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "7", "codes": "UDI-DI: 06971576832170.  Serial Number:  11MI410003/R001.19.4.1909524,  11MI410004/R001.19.4.1909524,  11MI410005/R001.19.4.1909524,  20MI410001/R001.19.4.1909524,  20MI410002/R001.19.4.1909524,  20MI410003/R001.21.0.1993334,  20MI410004/R001.19.4.1909524", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3284-2026%22", "url": "https://recallledger.net/recalls/device-z-3284-2026-positron-emission-tomography-and-computed-tomography-system-model-um/"}, {"id": "fda-device-z-3283-2026", "source": "FDA", "category": "device", "recall_number": "Z-3283-2026", "title": "Positron Emission Tomography and Computed Tomography System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "34", "codes": "UDI-DI: 06971576832026.  Serial Number/Software:  200045/R001.19.0.1812568,  200163/R001.19.3.2011750,  200164/R001.18.0.1683822,  200165/R001.18.0.1683822,  200166/R001.18.0.1683822,  200167/R001.18.0.1683822,  202009/R001.19.3.2011750,  202016/R001.19.0.1812568,  202018/R001.19.0.1812568,  202019/R001.19.0.1812568,  202020/R001.19.1.1929746,  202021/R001.19.1.1929746,  202022/R001.19.1.1929746,  230040/R001.19.3.2011750,  230048/R001.19.0.1812568,  230106/R001.19.0.1812568,  232038/R001.19.0.1812568,  232039/R001.19.0.1812568,  232040/R001.19.0.1812568,  232041/R001.19.0.1812568,  232042/R001.19.0.1812568,  232043/R001.19.0.1812568,  232044/R001.19.0.1812568,  232045/R001.19.0.1812568,  232046/R001.19.0.1812568,  232047/R001.19.0.1812568,  232048/R001.19.1.1929746,  232049/R001.19.1.1929746,  232050/R001.19.1.1929746,  232051/R001.19.1.1929746,  202023/R001.19.1.1929746,  202024/R001.19.1.1929746,  232052/R001.19.1.1929746,  232053/R001.19.1.1929746", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3283-2026%22", "url": "https://recallledger.net/recalls/device-z-3283-2026-positron-emission-tomography-and-computed-tomography-system-model-um/"}, {"id": "fda-device-z-3282-2026", "source": "FDA", "category": "device", "recall_number": "Z-3282-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT ATLAS Astound with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "53", "codes": "UDI-DI: 06971576831340.  Serial Number/Software:  803011/R002.9.0.1897081-Re3310SP1,  803012/R002.4.6.1607336-Re3100SP4,  803013/R002.4.6.1607336-Re3100SP4,  803014/R002.9.0.1897081-Re3310SP1,  803016/R002.4.6.1607336-Re3100SP4,  803017/R002.9.0.1897081-Re3310SP1,  803018/R002.9.0.1897081-Re3310SP1,  803019/R002.4.6.1607336-Re3100SP4,  803020/R002.9.0.1897081-Re3310SP1,  803022/R002.9.0.1897081-Re3310SP1,  803023/R002.9.0.1897081-Re3310SP1,  803024/R002.9.0.1897081-Re3310SP1,  809001/R002.8.1.1840891-Re3310A_P1,  809002/R002.9.0.1897081-Re3310SP1,  809003/R002.8.1.1840891-Re3310A_P1,  809004/R002.4.6.1607336-Re3100SP4,  809005/R002.4.6.1607336-Re3100SP4,  809006/R002.8.1.1840891-Re3310A_P1,  809007/R002.4.7.1671762-Re3100SP4_P1,  809008/R002.4.7.1671762-Re3100SP4_P1,  809009/R002.4.7.1671762-Re3100SP4_P1,  809010/R002.4.7.1671762-Re3100SP4_P1,  809011/R002.4.7.1671762-Re3100SP4_P1,  809012/R002.4.7.1671762-Re3100SP4_P1,  809013/R002.4.7.1671762-Re3100SP4_P1,  809014/R002.7.4.1810621-Re3300SP1H1_P3,  809015/R002.7.4.1810621-Re3300SP1H1_P3,  809016/R002.9.0.1897081-Re3310SP1,  809017/R002.9.0.1897081-Re3310SP1,  809018/R002.7.4.1810621-Re3300SP1H1_P3,  809019/R002.7.4.1810621-Re3300SP1H1_P3,  809020/R002.9.0.1897081-Re3310SP1,  809021/R002.7.4.1810621-Re3300SP1H1_P3,  809022/R002.7.4.1810621-Re3300SP1H1_P3,  809023/R002.7.4.1810621-Re3300SP1H1_P3,  809024/R002.7.4.1810621-Re3300SP1H1_P3,  809025/R002.7.4.1810621-Re3300SP1H1_P3,  809026/R002.7.4.1810621-Re3300SP1H1_P3,  809027/R002.7.4.1810621-Re3300SP1H1_P3,  809028/R002.9.0.1897081-Re3310SP1,  809029/R002.7.4.1810621-Re3300SP1H1_P3,  809030/R002.7.4.1810621-Re3300SP1H1_P3,  809031/R002.7.4.1810621-Re3300SP1H1_P3,  809032/R002.7.4.1810621-Re3300SP1H1_P3,  809033/R002.9.0.1897081-Re3310SP1,  809034/R002.9.0.1897081-Re3310SP1, 809035/R002.9.0.1897081-Re3310SP1,  809036/R002.9.0.1897081-Re3310SP1, 809037/R002.9.0.1897081-Re3310SP1, 809038/R002.9.0.1897081-Re3310SP1, 809039/R002.9.0.1897081-Re3310SP1,  809040/R002.9.0.1897081-Re3310SP1,  809041/R002.9.0.1897081-Re3310SP1", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3282-2026%22", "url": "https://recallledger.net/recalls/device-z-3282-2026-computed-tomography-x-ray-system-model-uct-atlas-astound-with-softwa/"}, {"id": "fda-device-z-3281-2026", "source": "FDA", "category": "device", "recall_number": "Z-3281-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT ATLAS with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "11", "codes": "UDI-DI: 06971576831104.  Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4,  863002/R001.17.6.1607336-Re3100SP4,  863004/R001.17.6.1607336-Re3100SP4,  863005/R001.17.6.1607336-Re3100SP4,  863007/R001.21.0.1897081-Re3310SP1,  863008/R001.21.0.1897081-Re3310SP1,  869001/R001.22.0.2012850-Re3320,  869002/R001.19.4.1810621-Re3300SP1H1_P3,  869003/R001.21.0.1897081-Re3310SP1,  869004/R001.21.0.1897081-Re3310SP1,  11CT863010/R001.17.6.1607336-Re3100SP4", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3281-2026%22", "url": "https://recallledger.net/recalls/device-z-3281-2026-computed-tomography-x-ray-system-model-uct-atlas-with-software/"}, {"id": "fda-device-z-3280-2026", "source": "FDA", "category": "device", "recall_number": "Z-3280-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT 780 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "14", "codes": "UDI-DI: 06971576831050.  Serial Number/Software:  684001/R001.17.6.1607336-Re3100SP4,  684002/R001.17.6.1607336-Re3100SP4,  684003/R003.8.4.1810621-Re3300SP1H1_P3,  684004/R003.8.4.1810621-Re3300SP1H1_P3,  684005/R003.8.4.1810621-Re3300SP1H1_P3,  684006/R003.8.4.1810621-Re3300SP1H1_P3,  684007/R003.8.4.1810621-Re3300SP1H1_P3,  684008/R003.8.4.1810621-Re3300SP1H1_P3,  684009/R003.8.4.1810621-Re3300SP1H1_P3, 684010/R003.8.4.1810621-Re3300SP1H1_P3, 684011/R003.8.4.1810621-Re3300SP1H1_P3,  684012/R003.9.0.1776134-Re-3300SP2,  684013/R003.11.0.1897081-Re3310SP1,  684014/R003.11.0.1897081-Re3310SP1", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3280-2026%22", "url": "https://recallledger.net/recalls/device-z-3280-2026-computed-tomography-x-ray-system-model-uct-780-with-software/"}, {"id": "fda-device-z-3279-2026", "source": "FDA", "category": "device", "recall_number": "Z-3279-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT 760 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "1", "codes": "UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P3", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3279-2026%22", "url": "https://recallledger.net/recalls/device-z-3279-2026-computed-tomography-x-ray-system-model-uct-760-with-software/"}, {"id": "fda-device-z-3278-2026", "source": "FDA", "category": "device", "recall_number": "Z-3278-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT 550 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "23", "codes": "UDI-DI: 06971576831036.  Serial Numbers/Software:  353021/R001.19.6.1857994-Re3300SP1H1_P5,  353045/R001.19.6.1857994-Re3300SP1H1_P5,  353049/R001.19.6.1857994-Re3300SP1H1_P5,  354001/R001.19.6.1857994-Re3300SP1H1_P5,  354004/R001.19.6.1857994-Re3300SP1H1_P5,  354005/R001.19.6.1857994-Re3300SP1H1_P5,  354007/R001.19.6.1857994-Re3300SP1H1_P5,  354009/R001.19.6.1857994-Re3300SP1H1_P5,  354013/R001.19.6.1857994-Re3300SP1H1_P5,  354015/R001.19.6.1857994-Re3300SP1H1_P5,  354016/R001.19.6.1857994-Re3300SP1H1_P5,  354018/R001.17.6.1607336-Re3100SP4,  354020/R001.17.6.1607336-Re3100SP4,  354021/R001.17.6.1607336-Re3100SP4,  354022/R001.19.4.1810621-Re3300SP1H1_P3,  354023/R001.19.6.1857994-Re3300SP1H1_P5,  354024/R001.19.6.1857994-Re3300SP1H1_P5,  354025/R001.19.6.1857994-Re3300SP1H1_P5,  354026/R001.19.6.1857994-Re3300SP1H1_P5, 354027/R001.19.6.1857994-Re3300SP1H1_P5,  354028/R001.19.6.1857994-Re3300SP1H1_P5,  354029/R001.19.6.1857994-Re3300SP1H1_P5, 354030/R001.19.6.1857994-Re3300SP1H1_P5", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3278-2026%22", "url": "https://recallledger.net/recalls/device-z-3278-2026-computed-tomography-x-ray-system-model-uct-550-with-software/"}, {"id": "fda-device-z-3277-2026", "source": "FDA", "category": "device", "recall_number": "Z-3277-2026", "title": "Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)", "product": "Computed Tomography X-ray System, Model: uCT 530 with software", "reason": "Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.", "hazard_level": "Class II", "company": "Shanghai United Imaging Healthcare Co., Ltd.", "company_location": "Shanghai, China", "date": "2026-08-11", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.", "states": ["AL", "CA", "CO", "FL", "IA", "ID", "IL", "IN", "KY", "LA", "MA", "MI", "MO", "MS", "MT", "NC", "ND", "NE", "NJ", "NV", "NY", "OH", "PR", "SC", "TN", "TX", "UT", "WI", "WV"], "nationwide": true, "quantity": "4", "codes": "UDI-DI: 06971576831012.  Serial Numbers/Software:  300174/R001.19.5.1839204-Re3300SP1H1_P4,  304006/R001.17.6.1607336-Re3100SP4,  304007/R001.19.4.1810621-Re3300SP1H1_P3,  304008/R001.19.4.1810621-Re3300SP1H1_P3", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3277-2026%22", "url": "https://recallledger.net/recalls/device-z-3277-2026-computed-tomography-x-ray-system-model-uct-530-with-software/"}, {"id": "fda-device-z-3276-2026", "source": "FDA", "category": "device", "recall_number": "Z-3276-2026", "title": "Philips IntraSight Plus  REF: 797423 and 797417  100-120v-220-240v recall (Volcano Corp)", "product": "Philips IntraSight Plus  REF: 797423 and 797417  100-120v-220-240v,50/60hZ, 1000 VA", "reason": "Software system  may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.", "hazard_level": "Class II", "company": "Volcano Corp", "company_location": "San Diego, CA, United States", "date": "2026-08-06", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.", "states": ["AL", "CA", "GA", "MA", "MN", "TX"], "nationwide": true, "quantity": "19 systems", "codes": "UDI:  REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3276-2026%22", "url": "https://recallledger.net/recalls/device-z-3276-2026-philips-intrasight-plus-ref-797423-and-797417-100-120v-220-240v-50/"}, {"id": "fda-device-z-3275-2026", "source": "FDA", "category": "device", "recall_number": "Z-3275-2026", "title": "EnCor EnCompass Breast Biopsy and Tissue Removal System Console recall (Bard Peripheral Vascular Inc)", "product": "EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software", "reason": "Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2)  Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.", "hazard_level": "Class II", "company": "Bard Peripheral Vascular Inc", "company_location": "Tempe, AZ, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID, MI, KY, CT, IL, VA, MA, WI, NY, IN, TN, OH, UT.", "states": ["CA", "CT", "GA", "ID", "IL", "IN", "KS", "KY", "MA", "MI", "NC", "NY", "OH", "PA", "SC", "TN", "TX", "UT", "VA", "WI"], "nationwide": true, "quantity": "99", "codes": "Software Versions 1.1.1.10207 and 1.2.0.12133. UDI-DI: 00801741235221 and 00801741234248.  Serial Numbers: VTLNPX06, VTLNPX0F, VTLNPX0D, VTLNPX08, VTLNPX0K, VTLNPX0A, VTLNPX0C, VTLNPX0L, VTLNPX0J, VTLNPX04, VTLNPX0H, VTLNPX02, VTLPPX1G, VTLPPX1D, VTLPPX1C, VTLPPX1M, VTLPPX2H, VTLPPX2I, VTLPPX2F, VTLQPX15, VTLQPX1Q, VTLQPX1G, VTLQPX14, VTLQPX0T, VTLQPX1Y, VTLQPX1M, VTLQPX2G, VTLQPX1O, VTLQPX1K, VTLQPX19, VTLQPX2E, VTLQPX1W, VTLQPX10, VTLQPX1Z, VTLQPX24, VTLQPX21, VTLQPX0X, VTLQPX1E, VTLQPX0U, VTLQPX26, VTLQPX2F, VTLQPX25, VTLQPX0Z, VTLQPX18, VTLQPX28, VTLQPX20, VTLQPX27, VTLQPX11, VTLQPX2B, VTLQPX1F, VTLQPX2H, VTLQPX41, VTLQPX3T, VTLQPX43, VTLRPX0R, VTKYPX09, VTKYPX44, VTKYPX46, VTKYPX47, VTKYPX48, VTKYPX49, VTKZPX14, VTKZPX15, VTKZPX20, VTKZPX17, VTLNPX4I, VTLNPX49, VTLNPX4G, VTLNPX4N, VTLNPX4E, VTLNPX4L, VTLNPX44, VTLNPX46, VTLNPX4C, VTLPPX27, VTLPPX28, VTLPPX29, VTLPPX1Z, VTLPPX37, VTLPPX3B, VTLPPX34, VTLPPX38, VTLPPX36, VTLQPX0Q, VTLQPX0B, VTLQPX0E, VTLQPX0P, VTLQPX0F, VTLRPX0X, VTLRPX0Z, VTKYPX07, VTKYPX06, VTKYPX04, VTLNPX4B, VTLNPX42, VTLNPX4F, VTLPPX3D, VTLQPX0M, VTKYPX51", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3275-2026%22", "url": "https://recallledger.net/recalls/device-z-3275-2026-encor-encompass-breast-biopsy-and-tissue-removal-system-console-model/"}, {"id": "fda-device-z-3274-2026", "source": "FDA", "category": "device", "recall_number": "Z-3274-2026", "title": "Fisher Scientific Sure-Vue Urine hCG recall (Alere San Diego, Inc.)", "product": "Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;  Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;  Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217;  Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22;  Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG;  Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;", "reason": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "hazard_level": "Class II", "company": "Alere San Diego, Inc.", "company_location": "San Diego, CA, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.", "states": ["AL", "AR", "AZ", "CA", "CO", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "18,139,960", "codes": "All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3274-2026%22", "url": "https://recallledger.net/recalls/device-z-3274-2026-fisher-scientific-sure-vue-urine-hcg-model-part-fhc-102-23900526/"}, {"id": "fda-device-z-3273-2026", "source": "FDA", "category": "device", "recall_number": "Z-3273-2026", "title": "Fisher Scientific Sure-Vue Urine hCG Strip recall (Alere San Diego, Inc.)", "product": "Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;  McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;  Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072;  Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211;  Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21;  Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG;  Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;", "reason": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "hazard_level": "Class II", "company": "Alere San Diego, Inc.", "company_location": "San Diego, CA, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.", "states": ["AL", "AR", "AZ", "CA", "CO", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "13,256,075", "codes": "All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3273-2026%22", "url": "https://recallledger.net/recalls/device-z-3273-2026-fisher-scientific-sure-vue-urine-hcg-strip-model-part-fhc-101-23900/"}, {"id": "fda-device-z-3272-2026", "source": "FDA", "category": "device", "recall_number": "Z-3272-2026", "title": "Fisher Scientific Sure-Vue Serum/Urine hCG recall (Alere San Diego, Inc.)", "product": "Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;    Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;    Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075;    Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225;     Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021", "reason": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "hazard_level": "Class II", "company": "Alere San Diego, Inc.", "company_location": "San Diego, CA, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.", "states": ["AL", "AR", "AZ", "CA", "CO", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "5,331,585", "codes": "All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16;  P080021/M220P0800213/40001856, 2023-03-30", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3272-2026%22", "url": "https://recallledger.net/recalls/device-z-3272-2026-fisher-scientific-sure-vue-serum-urine-hcg-model-part-fhc-202-23900/"}, {"id": "fda-device-z-3271-2026", "source": "FDA", "category": "device", "recall_number": "Z-3271-2026", "title": "McKesson CONSULT hCG Urine Cassette recall (Alere San Diego, Inc.)", "product": "McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;  Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;  Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531,  FHC-A202/23900530;  McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002;  Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215;  Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23;  Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;", "reason": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "hazard_level": "Class II", "company": "Alere San Diego, Inc.", "company_location": "San Diego, CA, United States", "date": "2026-08-20", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.", "states": ["AL", "AR", "AZ", "CA", "CO", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MS", "MT", "NC", "ND", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "50,265,835", "codes": "All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 5001/ 20612479202744/1155958203, 12/15; 92210/10815845020130/1156015803, 07/16; 23900530/00613647000571/1155810105, 2018-01-15; 23900531/00613647000533/1155810105, 2018-01-15; 5002/20612479202768/1155958305, 12/15; 92215/10815845020123/1156015903, 07/16; B-1077-23/20885380020268/1155904805, 9/2014; MPH22025HCG/10884389191880/1156093402, 04-01-2015", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3271-2026%22", "url": "https://recallledger.net/recalls/device-z-3271-2026-mckesson-consult-hcg-urine-cassette-model-part-fhc-a102-5001-aler/"}, {"id": "fda-device-z-3228-2026", "source": "FDA", "category": "device", "recall_number": "Z-3228-2026", "title": "Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories    MDR107000P\tBED recall (Medline Industries, LP)", "product": "Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories    MDR107000P\tBED, MANUAL, MEDLITE", "reason": "Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-14", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.", "states": ["PR"], "nationwide": true, "quantity": "771,127 total", "codes": "MDR107000P UDI-DI 00080196288284  All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3228-2026%22", "url": "https://recallledger.net/recalls/device-z-3228-2026-medline-basic-homecare-beds-and-medlite-homecare-beds-and-accessories/"}, {"id": "fda-device-z-3227-2026", "source": "FDA", "category": "device", "recall_number": "Z-3227-2026", "title": "Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories recall (Medline Industries, LP)", "product": "Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants:    MDR510094\tPENDANT F/ MDR107002E   MDR520094\tPENDANT F/ MDR107003E  MDR530094\tPENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED  MDR540094\tPENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED", "reason": "Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-14", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.", "states": ["PR"], "nationwide": true, "quantity": "771,127 total", "codes": "MDR510094 UDI-DI 10888277363021 MDR520094 UDI-DI 10884389161692 MDR530094 UDI-DI 10197344119059 MDR540094 UDI-DI 10197344119066  All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3227-2026%22", "url": "https://recallledger.net/recalls/device-z-3227-2026-medline-basic-homecare-beds-and-medlite-homecare-beds-and-accessories/"}, {"id": "fda-device-z-3155-2026", "source": "FDA", "category": "device", "recall_number": "Z-3155-2026", "title": "Philips Medical Systems  Technologies Ltd. Spectral CT 7500 recall (Philips North America Llc)", "product": "Philips Medical Systems  Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333", "reason": "The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-18", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "U.S. and U.S. Territories.", "states": [], "nationwide": false, "quantity": "62", "codes": "UDI: (01)00884838101111", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3155-2026%22", "url": "https://recallledger.net/recalls/device-z-3155-2026-philips-medical-systems-technologies-ltd-spectral-ct-7500-software/"}, {"id": "fda-device-z-0066-2027", "source": "FDA", "category": "device", "recall_number": "Z-0066-2027", "title": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 18\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 18\" 2 LINE (10)  Model/Catalog Number: DT-7218-02Q    Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "5440", "codes": "Lot Code: Model Number:DT-7218-02Q UDI-DI: UDI UDI (01) 00840001403314  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, R1201STY, Q1115STY, P1015STY, N0530STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0066-2027%22", "url": "https://recallledger.net/recalls/device-z-0066-2027-brand-name-mpr-product-name-disposable-tourniquet-cuff-18-2-line-1/"}, {"id": "fda-device-z-0065-2027", "source": "FDA", "category": "device", "recall_number": "Z-0065-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 15\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 15\" 2 LINE (10)  Model/Catalog Number: DT-7115-02Q    Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "180", "codes": "Lot Code: Model Number:DT-7115-02Q UDI-DI: UDI UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, P1015STY, N0330STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0065-2027%22", "url": "https://recallledger.net/recalls/device-z-0065-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-15-2-line-1/"}, {"id": "fda-device-z-0064-2027", "source": "FDA", "category": "device", "recall_number": "Z-0064-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 15\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 15\" 1 LINE (10)  Model/Catalog Number: DT-7115-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "100", "codes": "Lot Code: Model Number:DT-7115-01Q UDI-DI: UDI UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0064-2027%22", "url": "https://recallledger.net/recalls/device-z-0064-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-15-1-line-1/"}, {"id": "fda-device-z-0063-2027", "source": "FDA", "category": "device", "recall_number": "Z-0063-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 12\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 12\" 2 LINE (10)  Model/Catalog Number: DT-7112-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "80", "codes": "Lot Code: Model Number: DT-7112-02Q UDI-DI: UDI UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  Q0301STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0063-2027%22", "url": "https://recallledger.net/recalls/device-z-0063-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-12-2-line-1/"}, {"id": "fda-device-z-0062-2027", "source": "FDA", "category": "device", "recall_number": "Z-0062-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 12\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 12\" 1 LINE (10)  Model/Catalog Number: DT-7112-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "30", "codes": "Lot Code: Model Number: DT-7112-01Q UDI-DI: UDI UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  O1020STY, N0530STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2027%22", "url": "https://recallledger.net/recalls/device-z-0062-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-12-1-line-1/"}, {"id": "fda-device-z-0061-2027", "source": "FDA", "category": "device", "recall_number": "Z-0061-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 8\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 8\" 2 LINE (10)  Model/Catalog Number: DT-7108-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "40", "codes": "Lot Code: Model Number: DT-7108-02Q UDI-DI: UDI UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, R1201STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0061-2027%22", "url": "https://recallledger.net/recalls/device-z-0061-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-8-2-line-10/"}, {"id": "fda-device-z-0060-2027", "source": "FDA", "category": "device", "recall_number": "Z-0060-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 44\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 44\" 2 LINE (10)  Model/Catalog Number: DT-7044-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "360", "codes": "Lot Code: Model Number: DT-7044-02Q UDI-DI: UDI (01) 00840001403253  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, R1201STY, N0330STY, N0530STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0060-2027%22", "url": "https://recallledger.net/recalls/device-z-0060-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-44-2-line-1/"}, {"id": "fda-device-z-0059-2027", "source": "FDA", "category": "device", "recall_number": "Z-0059-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 44\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 44\" 1 LINE (10)  Model/Catalog Number: DT-7044-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "410", "codes": "Lot Code: Model Number: DT-7044-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  R1201STY, P1015STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0059-2027%22", "url": "https://recallledger.net/recalls/device-z-0059-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-44-1-line-1/"}, {"id": "fda-device-z-0058-2027", "source": "FDA", "category": "device", "recall_number": "Z-0058-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 34\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 34\" 2 LINE (10)  Model/Catalog Number: DT-7034-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "4480", "codes": "Lot Code: Model Number: DT-7034-02Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2027%22", "url": "https://recallledger.net/recalls/device-z-0058-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-34-2-line-1/"}, {"id": "fda-device-z-0057-2027", "source": "FDA", "category": "device", "recall_number": "Z-0057-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 34\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 34\" 1 LINE (10)  Model/Catalog Number: DT-7034-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "850", "codes": "Lot Code: Model Number: DT-7034-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  R1201STY, Q1115STY, P1015STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0057-2027%22", "url": "https://recallledger.net/recalls/device-z-0057-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-34-1-line-1/"}, {"id": "fda-device-z-0056-2027", "source": "FDA", "category": "device", "recall_number": "Z-0056-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 30\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 30\" 2 LINE (10)  Model/Catalog Number: DT-7030-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "820", "codes": "Lot Code: Model Number: DT-7030-02Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, R1201STY, Q1115STY, O1020STY, N0330STY, N0530STY, N0730STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0056-2027%22", "url": "https://recallledger.net/recalls/device-z-0056-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-30-2-line-1/"}, {"id": "fda-device-z-0055-2027", "source": "FDA", "category": "device", "recall_number": "Z-0055-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 30\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 30\" 1 LINE (10)  Model/Catalog Number: DT-7030-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1100", "codes": "Lot Code: Model Number: DT-7030-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, P1015STY, N0330STY, N0730STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0055-2027%22", "url": "https://recallledger.net/recalls/device-z-0055-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-30-1-line-1/"}, {"id": "fda-device-z-0054-2027", "source": "FDA", "category": "device", "recall_number": "Z-0054-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 24\" 2 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 24\" 2 LINE (10)  Model/Catalog Number: DT-7024-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "970", "codes": "Lot Code: Model Number: DT-7024-02Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  R1201STY, Q0301STY, Q1115STY, O1020STY, N0330STY, N0530STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0054-2027%22", "url": "https://recallledger.net/recalls/device-z-0054-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-24-2-line-1/"}, {"id": "fda-device-z-0053-2027", "source": "FDA", "category": "device", "recall_number": "Z-0053-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 24\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 24\" 1 LINE (10)  Model/Catalog Number: DT-7024-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1740", "codes": "Lot Code: Model Number: DT-7024-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, R1201STY, Q0301STY, Q1115STY, P1015STY, N0330STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0053-2027%22", "url": "https://recallledger.net/recalls/device-z-0053-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-24-1-line-1/"}, {"id": "fda-device-z-0052-2027", "source": "FDA", "category": "device", "recall_number": "Z-0052-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 18\" 1 LINE recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 18\" 1 LINE (10)  Model/Catalog Number: DT-7018-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "2750", "codes": "Lot Code: Model Number: DT-7018-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  S1101STY, Q0301STY, P1015STY, N0330STY, N0530STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0052-2027%22", "url": "https://recallledger.net/recalls/device-z-0052-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-18-1-line-1/"}, {"id": "fda-device-z-0051-2027", "source": "FDA", "category": "device", "recall_number": "Z-0051-2027", "title": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 26\" DUAL BLADDER recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:SINGLE USE TOURNIQUET CUFF 26\" DUAL BLADDER, 2 LINE (10)  Model/Catalog Number: DB-7024-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "50", "codes": "Lot Code: Model Number: DB-7024-02Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  N0330STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0051-2027%22", "url": "https://recallledger.net/recalls/device-z-0051-2027-brand-name-mpr-product-name-single-use-tourniquet-cuff-26-dual-blad/"}, {"id": "fda-device-z-0050-2027", "source": "FDA", "category": "device", "recall_number": "Z-0050-2027", "title": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 20\" DUAL BLADDER recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 20\" DUAL BLADDER, 2 LINE (10)  Model/Catalog Number: DB-7020-02Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "20", "codes": "Lot Code: Model Number: DB-7020-02Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  Q1115STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0050-2027%22", "url": "https://recallledger.net/recalls/device-z-0050-2027-brand-name-mpr-product-name-disposable-tourniquet-cuff-20-dual-blad/"}, {"id": "fda-device-z-0049-2027", "source": "FDA", "category": "device", "recall_number": "Z-0049-2027", "title": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 20\" DUAL BLADDER recall (ASP Global, LLC.)", "product": "Brand Name: MPR  Product Name:DISPOSABLE TOURNIQUET CUFF 20\" DUAL BLADDER, 1 LINE (10)  Model/Catalog Number: DB-7018-01Q  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "30", "codes": "Lot Code: Model Number: DB-7018-01Q UDI-DI: UDI was not applicable at time of manufacture.  All Lots produced from 01SEP2016 to 01MAR2023:  N0330STY, Q1115STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0049-2027%22", "url": "https://recallledger.net/recalls/device-z-0049-2027-brand-name-mpr-product-name-disposable-tourniquet-cuff-20-dual-blad/"}, {"id": "fda-device-z-0048-2027", "source": "FDA", "category": "device", "recall_number": "Z-0048-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 2-Line, Green    Model/Catalog Number: ASP-564015  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "6510", "codes": "Lot Code: Model Number: ASP-564015 UDI-DI: (01) 00840216106802  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0048-2027%22", "url": "https://recallledger.net/recalls/device-z-0048-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-44-x/"}, {"id": "fda-device-z-0047-2027", "source": "FDA", "category": "device", "recall_number": "Z-0047-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 1-Line, Green  Model/Catalog Number: ASP-564014  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "4850", "codes": "Lot Code: Model Number: ASP-564014 UDI-DI: (01) 00840216106796  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0047-2027%22", "url": "https://recallledger.net/recalls/device-z-0047-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-44-x/"}, {"id": "fda-device-z-0046-2027", "source": "FDA", "category": "device", "recall_number": "Z-0046-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 2-Line, Blue  Model/Catalog Number: ASP-564013  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "65640", "codes": "Lot Code: Model Number: ASP-564013 UDI-DI: (01) 00840216106789  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0046-2027%22", "url": "https://recallledger.net/recalls/device-z-0046-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-34-x/"}, {"id": "fda-device-z-0045-2027", "source": "FDA", "category": "device", "recall_number": "Z-0045-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 1-Line, Blue    Model/Catalog Number: ASP-564012  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "53040", "codes": "Lot Code: Model Number: ASP-564012 UDI-DI: (01) 00840216106772  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2027%22", "url": "https://recallledger.net/recalls/device-z-0045-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-34-x/"}, {"id": "fda-device-z-0044-2027", "source": "FDA", "category": "device", "recall_number": "Z-0044-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 2-Line, White  Model/Catalog Number: ASP-564011  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "45960", "codes": "Lot Code: Model Number: ASP-564011 UDI-DI: (01) 00840216106765  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2027%22", "url": "https://recallledger.net/recalls/device-z-0044-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-30-x/"}, {"id": "fda-device-z-0043-2027", "source": "FDA", "category": "device", "recall_number": "Z-0043-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 1-Line, White  Model/Catalog Number: ASP-564010  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "34550", "codes": "Lot Code: Model Number: ASP-564010 UDI-DI: (01) 00840216106758  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0043-2027%22", "url": "https://recallledger.net/recalls/device-z-0043-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-30-x/"}, {"id": "fda-device-z-0042-2027", "source": "FDA", "category": "device", "recall_number": "Z-0042-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 2-Line, Yellow  Model/Catalog Number: ASP-564009  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "20760", "codes": "Lot Code: Model Number: ASP-564009 UDI-DI: (01) 00840216106741  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0042-2027%22", "url": "https://recallledger.net/recalls/device-z-0042-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-24-x/"}, {"id": "fda-device-z-0041-2027", "source": "FDA", "category": "device", "recall_number": "Z-0041-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 1-Line, Yellow  Model/Catalog Number: ASP-564008  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "15580", "codes": "Lot Code: Model Number: ASP-564008 UDI-DI: (01) 00840216106734  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0041-2027%22", "url": "https://recallledger.net/recalls/device-z-0041-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-24-x/"}, {"id": "fda-device-z-0040-2027", "source": "FDA", "category": "device", "recall_number": "Z-0040-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 2-Line, Red  Model/Catalog Number: ASP-564007  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "55050", "codes": "Lot Code: Model Number: ASP-564007 UDI-DI: (01) 00840216106727  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0430STY, M0730STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2027%22", "url": "https://recallledger.net/recalls/device-z-0040-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-18-x/"}, {"id": "fda-device-z-0039-2027", "source": "FDA", "category": "device", "recall_number": "Z-0039-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 1-Line, Red  Model/Catalog Number: ASP-564006  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "36680", "codes": "Lot Code: Model Number: ASP-564006 UDI-DI: (01) 00840216106710  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, N0730STY, M0130STY, M0730STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0039-2027%22", "url": "https://recallledger.net/recalls/device-z-0039-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-18-x/"}, {"id": "fda-device-z-0038-2027", "source": "FDA", "category": "device", "recall_number": "Z-0038-2027", "title": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: ASP Global  Product Name:DISPOSABLE TOURNIQUET CUFF, 12\" X 3.5\" 2-Line, Plum  Model/Catalog Number: ASP-564003  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "10060", "codes": "Lot Code: Model Number: ASP-564003 UDI-DI: (01) 00840216106703  All Lots produced from 01SEP2016 to 01MAR2023:  P1015STY, P1215STY, N0330STY, N0530STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0228STY, L0310STY, L0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0038-2027%22", "url": "https://recallledger.net/recalls/device-z-0038-2027-brand-name-asp-global-product-name-disposable-tourniquet-cuff-12-x/"}, {"id": "fda-device-z-0037-2027", "source": "FDA", "category": "device", "recall_number": "Z-0037-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF, 26\" X 6\" DUAL BLADDER, 2-LINE (CS 12) ORANGE    Model/Catalog Number: A70107017  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "36", "codes": "Lot Code: Model Number: A70107017 UDI-DI: (01) 00885914035610  All Lots produced from 01SEP2016 to 01MAR2023:  Q0301STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0037-2027%22", "url": "https://recallledger.net/recalls/device-z-0037-2027-brand-name-expressaire-product-name-disposable-bb-tournquet-cuff-26/"}, {"id": "fda-device-z-0036-2027", "source": "FDA", "category": "device", "recall_number": "Z-0036-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF, 26\" X 6\" DUAL BLADDER, 1-LINE (CS 12) ORANGE  Model/Catalog Number: A70107016  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "36", "codes": "Lot Code: Model Number: A70107016 UDI-DI: (01) 00885914035603  All Lots produced from 01SEP2016 to 01MAR2023:  P0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0036-2027%22", "url": "https://recallledger.net/recalls/device-z-0036-2027-brand-name-expressaire-product-name-disposable-bb-tournquet-cuff-26/"}, {"id": "fda-device-z-0035-2027", "source": "FDA", "category": "device", "recall_number": "Z-0035-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE BB TOURNQUET CUFF, 20\" X 6\" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE  Model/Catalog Number: A70107014  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1056", "codes": "Lot Code: Model Number: A70107014 UDI-DI: (01) 00885914035580  All Lots produced from 01SEP2016 to 01MAR2023:  Q0930STY, Q1115STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0035-2027%22", "url": "https://recallledger.net/recalls/device-z-0035-2027-brand-name-expressaire-product-name-disposable-bb-tournquet-cuff-20/"}, {"id": "fda-device-z-0034-2027", "source": "FDA", "category": "device", "recall_number": "Z-0034-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 2-LINE (CS 12) GREEN  Model/Catalog Number: A70107013  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "2244", "codes": "Lot Code: Model Number: A70107013 UDI-DI: (01) 00885914035573  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, R0310STY, R0601STY, R0801STY, Q1115STY, P0620STY, O0120STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0034-2027%22", "url": "https://recallledger.net/recalls/device-z-0034-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-44/"}, {"id": "fda-device-z-0033-2027", "source": "FDA", "category": "device", "recall_number": "Z-0033-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 1-LINE (CS 12) GREEN  Model/Catalog Number: A70107012  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "2304", "codes": "Lot Code: Model Number: A70107012 UDI-DI: (01) 00885914035566  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P1215STY, O1020STY, N0730STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0033-2027%22", "url": "https://recallledger.net/recalls/device-z-0033-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-44/"}, {"id": "fda-device-z-0032-2027", "source": "FDA", "category": "device", "recall_number": "Z-0032-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 2-LINE (CS 18) BLUE  Model/Catalog Number: A70107011  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "6319", "codes": "Lot Code: Model Number: A70107011 UDI-DI: (01) 00885914035559  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R0801STY, Q0301STY, N0730STY, M0130STY, M0930STY, M1230STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2027%22", "url": "https://recallledger.net/recalls/device-z-0032-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-34/"}, {"id": "fda-device-z-0031-2027", "source": "FDA", "category": "device", "recall_number": "Z-0031-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 1-LINE (CS 18) BLUE  Model/Catalog Number: A70107010  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "33102", "codes": "Lot Code: Model Number: A70107010 UDI-DI: (01) 00885914035542  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R0310STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P1015STY, O0120STY, O0815STY, N0730STY, M1230STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0031-2027%22", "url": "https://recallledger.net/recalls/device-z-0031-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-34/"}, {"id": "fda-device-z-0030-2027", "source": "FDA", "category": "device", "recall_number": "Z-0030-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 2-LINE (CS 18) YELLOW  Model/Catalog Number: A70107009  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "5738", "codes": "Lot Code: Model Number: A70107009 UDI-DI: (01) 00885914035535  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, R0310STY, R0601STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, O1020STY, N0730STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0030-2027%22", "url": "https://recallledger.net/recalls/device-z-0030-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-24/"}, {"id": "fda-device-z-0029-2027", "source": "FDA", "category": "device", "recall_number": "Z-0029-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 1-LINE (CS 18) YELLOW  Model/Catalog Number: A70107008  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "12114", "codes": "Lot Code: Model Number: A70107008 UDI-DI: (01) 00885914035528  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S1101STY, R0310STY, R0601STY, R1101STY, R1201STY, Q1115STY, P0325STY, P1015STY, N0730STY, M1230STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0029-2027%22", "url": "https://recallledger.net/recalls/device-z-0029-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-24/"}, {"id": "fda-device-z-0028-2027", "source": "FDA", "category": "device", "recall_number": "Z-0028-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 2-LINE (CS 18) RED  Model/Catalog Number: A70107007  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "8807", "codes": "Lot Code: Model Number: A70107007 UDI-DI: (01) 00885914035511  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, S1214STY, R1101STY, R1201STY, Q0301STY, Q1115STY, P0325STY, P1015STY, O0120STY, N0730STY, M1230STY, L0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2027%22", "url": "https://recallledger.net/recalls/device-z-0028-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-18/"}, {"id": "fda-device-z-0027-2027", "source": "FDA", "category": "device", "recall_number": "Z-0027-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 1-LINE (CS 18) RED  Model/Catalog Number: A70107006  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "27090", "codes": "Lot Code: Model Number: A70107006 UDI-DI: (01) 00885914035504  All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1214STY, R0601STY, R1101STY, Q0930STY, Q1115STY, P0325STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2027%22", "url": "https://recallledger.net/recalls/device-z-0027-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-18/"}, {"id": "fda-device-z-0026-2027", "source": "FDA", "category": "device", "recall_number": "Z-0026-2027", "title": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name:DISPOSABLE TOURNIQUET CUFF, 15\" X 4\" 2-LINE (CS 12) GRAY  Model/Catalog Number: A70107005  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "2112", "codes": "Lot Code: Model Number: A70107005 UDI-DI: (01) 00885914035498  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1214STY, R0601STY, R0801STY, Q0301STY, Q1115STY, P0620STY, P1015STY, N0730STY, M0130STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0026-2027%22", "url": "https://recallledger.net/recalls/device-z-0026-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-15/"}, {"id": "fda-device-z-0025-2027", "source": "FDA", "category": "device", "recall_number": "Z-0025-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 15\" X 4\" 1-LINE (CS 12) GRAY  Model/Catalog Number: A70107004  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "396", "codes": "Lot Code: Model Number: A70107004 UDI-DI: (01) 00885914035481  All Lots produced from 01SEP2016 to 01MAR2023:  R0310STY, R1201STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2027%22", "url": "https://recallledger.net/recalls/device-z-0025-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-15/"}, {"id": "fda-device-z-0024-2027", "source": "FDA", "category": "device", "recall_number": "Z-0024-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 12\" X 3.5\" 2-LINE (CS 12) PLUM  Model/Catalog Number: A70107003  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1899", "codes": "Lot Code: Model Number: A70107003 UDI-DI: (01) 00885914035474  All Lots produced from 01SEP2016 to 01MAR2023:  R0601STY, Q0301STY, Q1115STY, P0620STY, P1015STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY, O0120STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2027%22", "url": "https://recallledger.net/recalls/device-z-0024-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-12/"}, {"id": "fda-device-z-0023-2027", "source": "FDA", "category": "device", "recall_number": "Z-0023-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 12\" X 3.5\" 1-LINE (CS 12) PLUM  Model/Catalog Number: A70107002  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1692", "codes": "Lot Code: Model Number: A70107002 UDI-DI: (01) 00885914035467  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, R0601STY, R0801STY, Q0301STY, P1015STY, O0120STY, N0730STY, M0130STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2027%22", "url": "https://recallledger.net/recalls/device-z-0023-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-12/"}, {"id": "fda-device-z-0022-2027", "source": "FDA", "category": "device", "recall_number": "Z-0022-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 8\" X 2.5\" 2-LINE (CS 12) LIGHT BLUE  Model/Catalog Number: A70107001  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "240", "codes": "Lot Code: Model Number: A70107001 UDI-DI: (01) 00885914035450    All Lots produced from 01SEP2016 to 01MAR2023:  R1201STY, Q0301STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2027%22", "url": "https://recallledger.net/recalls/device-z-0022-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-8/"}, {"id": "fda-device-z-0021-2027", "source": "FDA", "category": "device", "recall_number": "Z-0021-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 8\" X 2.5\" 1-LINE (CS 12) LIGHT BLUE  Model/Catalog Number: A70107000  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "156", "codes": "Lot Code: Model Number: A70107000 UDI-DI: (01) 00885914035443     All Lots produced from 01SEP2016 to 01MAR2023:  R1101STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0021-2027%22", "url": "https://recallledger.net/recalls/device-z-0021-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-8/"}, {"id": "fda-device-z-0020-2027", "source": "FDA", "category": "device", "recall_number": "Z-0020-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 38\" X 4\" 1-LINE (CS 10)  Model/Catalog Number: 564044  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "10", "codes": "Lot Code: Model Number: 564044 UDI-DI: (01) 00885914044964    All Lots produced from 01SEP2016 to 01MAR2023:  Q0301STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0020-2027%22", "url": "https://recallledger.net/recalls/device-z-0020-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-38/"}, {"id": "fda-device-z-0019-2027", "source": "FDA", "category": "device", "recall_number": "Z-0019-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 26\" X 6\" 1-LINE (CS 10) ORANGE  Model/Catalog Number: 564019  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "260", "codes": "Lot Code: Model Number: 564019 UDI-DI: (01) 00885914044698    All Lots produced from 01SEP2016 to 01MAR2023:  R0310STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0019-2027%22", "url": "https://recallledger.net/recalls/device-z-0019-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-26/"}, {"id": "fda-device-z-0018-2027", "source": "FDA", "category": "device", "recall_number": "Z-0018-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 20\" X 6\" 1-LINE (CS 10) NAVY BLUE  Model/Catalog Number: 564017  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "1220", "codes": "Lot Code: Model Number: 564017 UDI-DI: (01) 00885914044674    All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, R0310STY, Q0301STY, Q1115STY, O0815STY, O1020STY, N0330STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0018-2027%22", "url": "https://recallledger.net/recalls/device-z-0018-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-20/"}, {"id": "fda-device-z-0017-2027", "source": "FDA", "category": "device", "recall_number": "Z-0017-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 2-LINE (CS 10) GREEN  Model/Catalog Number: 564015  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "4530", "codes": "Lot Code: Model Number: 564015 UDI-DI: (01) 00885914044650    All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R1101STY, Q0301STY, Q1115STY, P0620STY, O0815STY, O1020STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0017-2027%22", "url": "https://recallledger.net/recalls/device-z-0017-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-44/"}, {"id": "fda-device-z-0016-2027", "source": "FDA", "category": "device", "recall_number": "Z-0016-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 44\" X 4\" 1-LINE (CS 10) GREEN  Model/Catalog Number: 564014  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "2600", "codes": "Lot Code: Model Number: 564014 UDI-DI: (01) 00885914044643    All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, S1214STY, R0601STY, R1101STY, Q0301STY, N0730STY, M0130STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2027%22", "url": "https://recallledger.net/recalls/device-z-0016-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-44/"}, {"id": "fda-device-z-0015-2027", "source": "FDA", "category": "device", "recall_number": "Z-0015-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 2-LINE (CS 10) BLUE  Model/Catalog Number: 564013  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "32390", "codes": "Lot Code: Model Number: 564013 UDI-DI: (01) 00885914044636    All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P0620STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0015-2027%22", "url": "https://recallledger.net/recalls/device-z-0015-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-34/"}, {"id": "fda-device-z-0014-2027", "source": "FDA", "category": "device", "recall_number": "Z-0014-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 34\" X 4\" 1-LINE (CS 10) BLUE  Model/Catalog Number: 564012  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "26810", "codes": "Lot Code: Model Number: 564012 UDI-DI: (01) 00885914044629     All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O1020STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0014-2027%22", "url": "https://recallledger.net/recalls/device-z-0014-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-34/"}, {"id": "fda-device-z-0013-2027", "source": "FDA", "category": "device", "recall_number": "Z-0013-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 2-LINE (CS 10) WHITE  Model/Catalog Number: 564011  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "15770", "codes": "Lot Code: Model Number: 564011 UDI-DI: (01) 00885914044612    All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0013-2027%22", "url": "https://recallledger.net/recalls/device-z-0013-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-30/"}, {"id": "fda-device-z-0012-2027", "source": "FDA", "category": "device", "recall_number": "Z-0012-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 1-LINE (CS 10) WHITE  Model/Catalog Number: 564010  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "6100", "codes": "Lot Code: Model Number: 564010 UDI-DI: (01) 00885914044605     All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, M0730STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2027%22", "url": "https://recallledger.net/recalls/device-z-0012-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-30/"}, {"id": "fda-device-z-0011-2027", "source": "FDA", "category": "device", "recall_number": "Z-0011-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 2-LINE (CS 10) YELLOW  Model/Catalog Number: 564009  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "7650", "codes": "Lot Code: Model Number: 564009 UDI-DI: (01) 00885914044599    All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O0815STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0011-2027%22", "url": "https://recallledger.net/recalls/device-z-0011-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-24/"}, {"id": "fda-device-z-0010-2027", "source": "FDA", "category": "device", "recall_number": "Z-0010-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 24\" X 4\" 1-LINE (CS 10) YELLOW  Model/Catalog Number: 564008  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "4610", "codes": "Lot Code: Model Number: 564008 UDI-DI: (01) 00885914044582   All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, N0330STY, N0730STY, M0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0010-2027%22", "url": "https://recallledger.net/recalls/device-z-0010-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-24/"}, {"id": "fda-device-z-0009-2027", "source": "FDA", "category": "device", "recall_number": "Z-0009-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 2-LINE (CS 10) RED  Model/Catalog Number: 564007  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "38380", "codes": "Lot Code: Model Number: 564007 UDI-DI: (01) 00885914044575    All Lots produced from 01SEP2016 to 01MAR2023:  S0823STY, S0922STY, S1101STY, R0310STY, R0801STY, R1101STY, R1201STY, Q1115STY, P0325STY, P0620STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2027%22", "url": "https://recallledger.net/recalls/device-z-0009-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-18/"}, {"id": "fda-device-z-0008-2027", "source": "FDA", "category": "device", "recall_number": "Z-0008-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 18\" X 4\" 1-LINE (CS 10) RED  Model/Catalog Number: 564006  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "25350", "codes": "Lot Code: Model Number: 564006 UDI-DI: (01) 00885914044568     All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, R1201STY, Q0930STY, Q1115STY, P1015STY, O0120STY, N0330STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2027%22", "url": "https://recallledger.net/recalls/device-z-0008-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-18/"}, {"id": "fda-device-z-0007-2027", "source": "FDA", "category": "device", "recall_number": "Z-0007-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 15\" X 4\" 2-LINE (CS 10) GRAY  Model/Catalog Number: 564005  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "70", "codes": "Lot Code: Model Number: 564005 UDI-DI: (01) 00885914044551     All Lots produced from 01SEP2016 to 01MAR2023:  P0325STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0007-2027%22", "url": "https://recallledger.net/recalls/device-z-0007-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-15/"}, {"id": "fda-device-z-0006-2027", "source": "FDA", "category": "device", "recall_number": "Z-0006-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 12\" X 3.5\" 2-LINE (CS 10) PLUM  Model/Catalog Number: 564003  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "3020", "codes": "Lot Code: Model Number: 564003 UDI-DI: (01) 00885914044537     All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, S1101STY, Q0930STY, Q1115STY, P1015STY, M0730STY, M0930STY, M1230STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2027%22", "url": "https://recallledger.net/recalls/device-z-0006-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-12/"}, {"id": "fda-device-z-0005-2027", "source": "FDA", "category": "device", "recall_number": "Z-0005-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 8\" X 2.5\" 2-LINE (CS 10)  Model/Catalog Number: 564001  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "400", "codes": "Lot Code: Model Number: 564001 UDI-DI: (01) 00885914044513     All Lots produced from 01SEP2016 to 01MAR2023:  Q0301STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0005-2027%22", "url": "https://recallledger.net/recalls/device-z-0005-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-8/"}, {"id": "fda-device-z-0004-2027", "source": "FDA", "category": "device", "recall_number": "Z-0004-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 2-LINE (CS 18) WHITE  Model/Catalog Number: 553323  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "18", "codes": "Lot Code: Model Number: 553323 UDI-DI: (01) 00885914010549    All Lots produced from 01SEP2016 to 01MAR2023:  Q1115STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2027%22", "url": "https://recallledger.net/recalls/device-z-0004-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-30/"}, {"id": "fda-device-z-0003-2027", "source": "FDA", "category": "device", "recall_number": "Z-0003-2027", "title": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)", "product": "Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 30\" X 4\" 1-LINE (CS 18) WHITE  Model/Catalog Number: 553322  Software Version: Not Applicable  Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field.  Component: No", "reason": "Due to incorrect expiration date on product manufactured between September 2016 to March 2023.  Products are labeled with a 10 year shelf life.  The correct validated shelf life is 5 years.", "hazard_level": "Class II", "company": "ASP Global, LLC.", "company_location": "Austell, GA, United States", "date": "2026-08-24", "report_date": "2026-10-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NJ", "NM", "NV", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI", "WY"], "nationwide": true, "quantity": "5015", "codes": "Lot Code: Model Number: 553322 UDI-DI: (01) 00885914010532  All Lots produced from 01SEP2016 to 01MAR2023:  S0922STY, R0310STY, R0801STY, Q0930STY, P0620STY, O0815STY, N0730STY, M0930STY", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2027%22", "url": "https://recallledger.net/recalls/device-z-0003-2027-brand-name-expressaire-product-name-disposable-tourniquet-cuff-30/"}, {"id": "fda-food-h-1392-2026", "source": "FDA", "category": "food", "recall_number": "H-1392-2026", "title": "Powdered Sugar recall (United Sugar Producers and Refiners)", "product": "Powdered Sugar, Packaged in the following configurations:   1.  United 6X, Net Wt. 50 lbs. (22.68kg), Item Number 810087.  UPC 7 85921-07090 4.  Distributed by:  United Sugar Producers & Refiners, Minneapolis, MN  55439.   2.  Crystal Sugar, Net Wt. 25 lbs. (11.3 kg), Item Number 810097.  UPC 0 70090-08090 9.  Distributed by Crystal Sugars Corporation, Moorhead, MN       2.  Good & Gather, Net Wt 2 lb. (32oz) 907g.  Item Number 817774.  UPC 0 85239-08455 7.  Dist. By Target Corp. Minneapolis, MN  55403.", "reason": "Potential Wheat Kernel contamination.", "hazard_level": "Class II", "company": "United Sugar Producers and Refiners", "company_location": "Minneapolis, MN, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "IA, IL, IN, KS, MN, OH PA, TX", "states": ["IA", "IL", "IN", "KS", "MN", "OH", "PA", "TX"], "nationwide": false, "quantity": "4,265 CWT total", "codes": "1.  Batch Numbers:  MHD26223, MHD26224, MHD26225, MHD26226, MHD26227, MHD26229.   2.  Batch Numbers:  MHD26230 3.  Batch Numbers:   MHD26223, MHD26224, MHD26225, MHD26226, MHD26227, MHD26228, MHD26229.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1392-2026%22", "url": "https://recallledger.net/recalls/food-h-1392-2026-powdered-sugar-packaged-in-the-following-configurations-1-united/"}, {"id": "fda-food-h-1391-2026", "source": "FDA", "category": "food", "recall_number": "H-1391-2026", "title": "Light Brown Sugar recall (United Sugar Producers and Refiners)", "product": "Light Brown Sugar, Packaged in he follow configurations:   1.  United, Net Wt. 50 lbs., (22.68kg).  Item Number 810051.  Distributed By:  United Sugar Producers & Refiners, Minneapolis, MN  55439.    2.  Good & Gather, Net Wt 2 lb. (32 oz) 907g.  Item Number 817773.  UPC 0 85239-08454 0.  Dist. By Target Corp., Minneapolis, MN  55403.", "reason": "Potential Wheat Kernel contamination.", "hazard_level": "Class II", "company": "United Sugar Producers and Refiners", "company_location": "Minneapolis, MN, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "IA, IL, IN, KS, MN, OH PA, TX", "states": ["IA", "IL", "IN", "KS", "MN", "OH", "PA", "TX"], "nationwide": false, "quantity": "12,678 CWT total", "codes": "1.  Batch Numbers:  MHD26223, MHD26224, MHD26225, MHD26226, MHD26227, MHD26228, MHD26229, MHD26223, MHD26225, MHD26226, MHD26223, MHD26225, MHD26226.   2.  Batch Numbers:  MHD26223, MHD26224, MHD26225, MHD26226, MHD26227, MHD26228, MHD26229.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1391-2026%22", "url": "https://recallledger.net/recalls/food-h-1391-2026-light-brown-sugar-packaged-in-he-follow-configurations-1-united/"}, {"id": "fda-drug-d-0868-2026", "source": "FDA", "category": "drug", "recall_number": "D-0868-2026", "title": "Exenatide Injection recall (Amneal Pharmaceuticals of New York, LLC)", "product": "Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1", "reason": "Defective Delivery System: Possibility of no medication in the prefilled pen.", "hazard_level": "Class II", "company": "Amneal Pharmaceuticals of New York, LLC", "company_location": "Brookhaven, NY, United States", "date": "2026-08-28", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "5,694 pens", "codes": "Lot #: AP250095A, Exp 2/28/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2026%22", "url": "https://recallledger.net/recalls/drug-d-0868-2026-exenatide-injection-usp-250-mcg-ml-1-2-ml-per-prefilled-pen-rx-onl/"}, {"id": "fda-drug-d-0867-2026", "source": "FDA", "category": "drug", "recall_number": "D-0867-2026", "title": "Olanzapine Tablets recall (Macleods Pharmaceuticals Limited)", "product": "Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.", "reason": "Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.", "hazard_level": "Class III", "company": "Macleods Pharmaceuticals Limited", "company_location": "Tehsil Baddi, District Solan, India", "date": "2026-08-27", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "22,032 30-count bottles", "codes": "Lot: BOB22321A, Exp 07-31-2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0867-2026%22", "url": "https://recallledger.net/recalls/drug-d-0867-2026-olanzapine-tablets-usp-5-mg-30-count-bottle-rx-only-manufactured-f/"}, {"id": "fda-drug-d-0863-2026", "source": "FDA", "category": "drug", "recall_number": "D-0863-2026", "title": "AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)", "product": "AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "107,377 packs", "codes": "Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0863-2026%22", "url": "https://recallledger.net/recalls/drug-d-0863-2026-avkare-carboxymethylcellulose-sodium-ophthalmic-solution-0-5-lubrica/"}, {"id": "fda-drug-d-0862-2026", "source": "FDA", "category": "drug", "recall_number": "D-0862-2026", "title": "Lubricant Eye Drops-Cameron Pharmaceuticals recall (Sterling Pharmaceutical Services LLC)", "product": "Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "19284 bottles", "codes": "Lot # 3163, Expiry: 8/31/2026; Lot# 3164, Expiry: 9/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0862-2026%22", "url": "https://recallledger.net/recalls/drug-d-0862-2026-lubricant-eye-drops-cameron-pharmaceuticals-carboxymethylcellulose-so/"}, {"id": "fda-drug-d-0861-2026", "source": "FDA", "category": "drug", "recall_number": "D-0861-2026", "title": "Major LubriFresh P.M. Nighttime Ointment recall (Sterling Pharmaceutical Services LLC)", "product": "Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "34368 tubes", "codes": "Lot # 3183", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0861-2026%22", "url": "https://recallledger.net/recalls/drug-d-0861-2026-major-lubrifresh-p-m-nighttime-ointment-net-wt-0-125-oz-3-5-g-tu/"}, {"id": "fda-drug-d-0860-2026", "source": "FDA", "category": "drug", "recall_number": "D-0860-2026", "title": "TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)", "product": "TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "14538 bottles", "codes": "Lot # 3279, Exp 6/30/2027; Lot # 3292, Exp 5/31/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0860-2026%22", "url": "https://recallledger.net/recalls/drug-d-0860-2026-trp-the-relief-products-gentle-eyes-lubricant-eye-drops-carboxymethy/"}, {"id": "fda-drug-d-0859-2026", "source": "FDA", "category": "drug", "recall_number": "D-0859-2026", "title": "Reliable-1 Laboratories Lubricating Tears recall (Sterling Pharmaceutical Services LLC)", "product": "Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "47616 bottles", "codes": "Lot # 3171, Expiration Date 09/30/2026.  Lot # 3174, Expiration Date 10/31/2026;  Lot #3275, Expiration Date, 06/30/2027; Lot #3304, Expiration date 07/31/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0859-2026%22", "url": "https://recallledger.net/recalls/drug-d-0859-2026-reliable-1-laboratories-lubricating-tears-sterile-0-5-fl-oz-15-ml/"}, {"id": "fda-drug-d-0858-2026", "source": "FDA", "category": "drug", "recall_number": "D-0858-2026", "title": "Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)", "product": "Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "199600 packs", "codes": "Lot # 3165, Expiry: 9/2026; Lot # 3179, Expiry: 10/2026; Lot # 3204, Expiry: 12/2026;  Lot #3206, Expiry: 12/2026, Lot # 3208, Expiry: 12/2026; Lot #3259, Expiry: 4/2027; Lot #: 3265, Expiry: 5/2027; Lot # 3268; Expiry 6/2027; Lot #3272, Expiry: 5/2027; Lot # 3273, Expiry: 6/2027; Lot #3276, Expiry: 6/2027; Lot # 3278, Expiry: 6/2027; Lot # 3280, Expiry: 6/2027; Lot # 3307, Expiry: 7/2027; Lot # 3309, Expiry: 7/2027; Lot # 3315, Expiry: 7/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0858-2026%22", "url": "https://recallledger.net/recalls/drug-d-0858-2026-walgreens-lubricant-eye-drops-0-5-fl-oz-15-ml-1-0-fl-oz-30-ml-tot/"}, {"id": "fda-drug-d-0857-2026", "source": "FDA", "category": "drug", "recall_number": "D-0857-2026", "title": "Walgreens Lubricant Eye Drops recall (Sterling Pharmaceutical Services LLC)", "product": "Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "301114 bottles", "codes": "Lot # 3166, Expiry: 9/2026; Lot # 3172, Expiry: 9/2026; Lot # 3173, Expiry: 9/2026; Lot # 3175, Expiry: 10/2026; Lot # 3176, Expiry: 10/2026; Lot # 3177, Expiry: 10/2026; Lot # 3178, Expiry:10/2026; Lot # 3180, Expiry: 11/2026; Lot # 3188, Expiry: 12/2026; Lot # 3202, Expiry: 12/2026; Lot # 3203, Expiry: 12/2026; Lot # 3205, Expiry: 12/2026; Lot # 3209, Expiry: 2/2027; Lot #3210, Expiry: 3/2027; Lot #3246, Expiry: 3/2027; Lot #3247, Expiry: 3/2027; Lot #3248, Expiry: 4/2027; Lot # 3249, Expiry: 4/2027; Lot # 3250, Expiry: 4/2027; Lot # 3252, Expiry: 4/2027; Lot # 3253, Expiry: 4/2027; Lot # 3261, Expiry: 5/2027; Lot # 3262, Expiry: 5/2027; Lot # 3263; Expiry 5/2027; Lot #3264, Expiry: 5/2027; Lot #3281, Expiry : 6/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0857-2026%22", "url": "https://recallledger.net/recalls/drug-d-0857-2026-walgreens-lubricant-eye-drops-carboxymethylcellulose-sodium-0-5-lub/"}, {"id": "fda-drug-d-0856-2026", "source": "FDA", "category": "drug", "recall_number": "D-0856-2026", "title": "Reliable -1 Laboratories recall (Sterling Pharmaceutical Services LLC)", "product": "Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "11083 bottles", "codes": "Lot #3192, Exp Date 01/312027;  3293, 3336 Exp Date 06/30/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0856-2026%22", "url": "https://recallledger.net/recalls/drug-d-0856-2026-reliable-1-laboratories-sodium-chloride-hypertonicity-ophthalmic-sol/"}, {"id": "fda-drug-d-0855-2026", "source": "FDA", "category": "drug", "recall_number": "D-0855-2026", "title": "AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recall (Sterling Pharmaceutical Services LLC)", "product": "AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15", "reason": "Lack of Assurance of Sterility", "hazard_level": "Class II", "company": "Sterling Pharmaceutical Services LLC", "company_location": "Dupo, IL, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "12,864 packs", "codes": "Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2026%22", "url": "https://recallledger.net/recalls/drug-d-0855-2026-avkare-carboxymethylcellulose-sodium-ophthalmic-solution-0-5-lubrica/"}, {"id": "fda-drug-d-0854-2026", "source": "FDA", "category": "drug", "recall_number": "D-0854-2026", "title": "MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ recall (SHANTOU Qiwei industrial Co., Ltd)", "product": "MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz,  Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China", "reason": "cGMP Deviations", "hazard_level": "Class II", "company": "SHANTOU Qiwei industrial Co., Ltd", "company_location": "Shantou, China", "date": "2026-08-08", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "CA only", "states": ["CA"], "nationwide": false, "quantity": "2970 units", "codes": "Lot #: 2024/10/11, Exp. Date 10/10/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2026%22", "url": "https://recallledger.net/recalls/drug-d-0854-2026-menow-sunscreen-pressed-powder-spf35-pa-net-content-9g-0-32-oz/"}, {"id": "fda-device-z-3269-2026", "source": "FDA", "category": "device", "recall_number": "Z-3269-2026", "title": "Medline Convenience Kits:  1) ANTERIOR SPINE PACK recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197;   2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001;   3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O;   4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P;   5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M;   6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G;   7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F;   8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C;   9) CRANI PACK, Catalog Number: DYNJ46672B;   10) SPINE TRAY II, Catalog Number: DYNJ52961I;   11) SPINE PACK, Catalog Number: DYNJ53518C;   12) SPINE PACK, Catalog Number: DYNJ54479C;   13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815;   14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C;   15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C;   16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C;   17) SPINAL PACK-LF, Catalog Number: DYNJ67543B;   18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A;   19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098;   20) SPINE, Catalog Number: DYNJ900269I;   21) PACK,CRANIOTOMY, Catalog Number: DYNJ906893C;   22) PACK,CRANIOTOMY, Catalog Number: DYNJ906893D;   23) PACK,CRANIOTOMY, Catalog Number: DYNJ906893F;   24) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192B;   25) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192C;   26) DR MOSHEL CRANI, Catalog Number: DYNJ907920C;   27) SPINE-LF, Catalog Number: DYNJ910956;   28) TOURO OR LAMINECTOMY PACK, Catalog Number: DYNJ912687", "reason": "The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "4013 kits", "codes": "1) DYNJT10197, UDI-DI: 10198459778865(each), 40198459778866(case), Lot Number: 26GBA998; 2) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23HLA649; 3) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA935; 4) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA081; 5) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23CLA457; 6) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23BLA516; 7) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22IBO169; 8) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22GBD964; 9) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22DBU156; 10) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24KBH955; 11) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24JBB595; 12) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24GMF624; 13) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24CMJ263; 14) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24BMK244; 15) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24AMF230; 16) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23JBJ151; 17) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23FBG216; 18) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23EBC638; 19) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23CBI768; 20) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABM980; 21) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABI593; 22) DYNJ04342M, UDI-DI: 10193489914672(each), 40193489914673(case), Lot Number: 23HMB096; 23) DYNJ43218G, UDI-DI: 10195327421977(each), 40195327421978(case), Lot Number: 23HMC253; 24) DYNJ46024F, UDI-DI: 10195327237011(each), 40195327237012(case), Lot Number: 23HBJ773; 25) DYNJ46070C, UDI-DI: 10193489853230(each), 40193489853231(case), Lot Number: 23HMC669; 26) DYNJ46672B, UDI-DI: 10889942278909(each), 40889942278900(case), Lot Number: 23HMA338; 27) DYNJ52961I, UDI-DI: 10195327346119(each), 40195327346110(case), Lot Number: 23HBD216; 28) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23CBG270; 29) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23BBB578; 30) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 22LBP140; 31) DYNJ54479C, UDI-DI: 10193489460254(each), 40193489460255(case), Lot Number: 23HBA720; 32) DYNJ57815, UDI-DI: 10889942779437(each), 40889942779438(case), Lot Number: 23HBP930; 33) DYNJ57971C, UDI-DI: 10195327225209(each), 40195327225200(case), Lot Number: 23GBT243; 34) DYNJ59338C, UDI-DI: 10195327021238(each), 40195327021239(case), Lot Number: 23HLA933; 35) DYNJ66742C, UDI-DI: 10195327343156(each), 40195327343157(case), Lot Number: 23GBS430; 36) DYNJ67543B, UDI-DI: 10195327471606(each), 40195327471607(case), Lot Number: 23HBG744; 37) DYNJ69214A, UDI-DI: 10195327184056(each), 40195327184057(case), Lot Number: 23GBR467; 38) DYNJ83098, UDI-DI: 10195327231316(each), 40195327231317(case), Lot Number: 23HMA427; 39) DYNJ900269I, UDI-DI: 10198459569524(each), 40198459569525(case), Lot Number: 26CMI592; 40) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22IBC626; 41) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22HBS240; 42) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMH504; 43) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMD199; 44) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24IMG055; 45) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24GMJ361; 46) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24EMD234; 47) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24DMG428; 48) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24BMI349; 49) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24AMG705; 50) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23LMF389; 51) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMK268; 52) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMB370; 53) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23IMC078; 54) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23HMH387; 55) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23GMD961; 56) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DME252; 57) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DMB260; 58) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23CMG273; 59) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26GMG394; 60) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26FMD545; 61) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMD616; 62) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA441; 63) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA421; 64) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMJ807; 65) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMB625; 66) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25HMI954; 67) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25FMC018; 68) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25EMF909; 69) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25CMF056; 70) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25AMF815; 71) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBW221; 72) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBD210; 73) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25EBM992; 74) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25DBN524; 75) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25BBQ529; 76) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24LBP184; 77) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24KBH441; 78) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24JBD802; 79) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24IBK611; 80) DYNJ907192B, UDI-DI: 24GBX565(each), 10193489946581(case), Lot Number: 40193489946582; 81) DYNJ907192B, UDI-DI: 24FBB829(each), 10193489946581(case), Lot Number: 40193489946582; 82) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24DBV145; 83) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24CBM496; 84) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24ABP283; 85) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23KBN917; 86) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23JBR304; 87) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBU169; 88) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBH841; 89) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23FBH149; 90) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23EBL017; 91) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23CBP523; 92) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF825; 93) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF826; 94) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22JBL437; 95) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA578; 96) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA287; 97) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBI511; 98) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBH553; 99) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26FBR970; 100) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26EBL570; 101) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26DBL401; 102) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26CBD787; 103) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25LBB786; 104) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBQ411; 105) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBH229; 106) DYNJ907920C, UDI-DI: 10198459124839(each), 40198459124830(case), Lot Number: 26DBQ234; 107) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25GMA962; 108) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25CMJ170; 109) DYNJ912687, UDI-DI: 10198459758485(each), 40198459758486(case), Lot Number: 26EBH822", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3269-2026%22", "url": "https://recallledger.net/recalls/device-z-3269-2026-medline-convenience-kits-1-anterior-spine-pack-catalog-number-dyn/"}, {"id": "fda-device-z-3268-2026", "source": "FDA", "category": "device", "recall_number": "Z-3268-2026", "title": "Medline Convenience Kits:  1) MAJOR NEURO VCH recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I;   2) NEURO PACK-LF, Catalog Number: DYNJ41246F;   3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A;   4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J;   5) NEURO, Catalog Number: DYNJ82388A;   6) NEURO PACK, Catalog Number: DYNJ86656;   7) NEURO ACD, Catalog Number: DYNJ904549G", "reason": "The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "234 kits", "codes": "1) DYNJ39218I, UDI-DI: 10195327013042(each), 40195327013043(case), Lot Number: 22HMA400; 2) DYNJ41246F, UDI-DI: 10195327112011(each), 40195327112012(case), Lot Number: 23GBS783; 3) DYNJ47487A, UDI-DI: 10889942106240(each), 40889942106241(case), Lot Number: 22HMD080; 4) DYNJ57233J, UDI-DI: 10198459723025(each), 40198459723026(case), Lot Number: 26CMG313; 5) DYNJ82388A, UDI-DI: 10195327482749(each), 40195327482740(case), Lot Number: 25KMB622; 6) DYNJ86656, UDI-DI: 10195327663155(each), 40195327663156(case), Lot Number: 24EDB134; 7) DYNJ904549G, UDI-DI: 10193489832686(each), 40193489832687(case), Lot Number: 23IBL172", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3268-2026%22", "url": "https://recallledger.net/recalls/device-z-3268-2026-medline-convenience-kits-1-major-neuro-vch-catalog-number-dynj392/"}, {"id": "fda-device-z-3267-2026", "source": "FDA", "category": "device", "recall_number": "Z-3267-2026", "title": "Medline Convenience Kits:  1) MFC CRANIOTOMY PACK recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;   2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q;   3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R;   4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S;   5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T", "reason": "The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "486 kits", "codes": "1) DYNJT8784, UDI-DI: 10198459756368(each), 40198459756369(case), Lot Number: 26EBN238; 2) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25GBC553; 3) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25FBA082; 4) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25EBP462; 5) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25DBU966; 6) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25CBS315; 7) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25JBB880; 8) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25HBF280; 9) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26CBK932; 10) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT826; 11) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT935; 12) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26EBG096; 13) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26DBM677", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3267-2026%22", "url": "https://recallledger.net/recalls/device-z-3267-2026-medline-convenience-kits-1-mfc-craniotomy-pack-catalog-number-dyn/"}, {"id": "fda-device-z-3266-2026", "source": "FDA", "category": "device", "recall_number": "Z-3266-2026", "title": "Medline Convenience Kits:  1) MAJOR PACK recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) MAJOR PACK, Catalog Number: DYNJ81325A", "reason": "The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "128 kits", "codes": "1) DYNJ81325A, UDI-DI: 10195327270360(each), 40195327270361(case), Lot Number: 23HBB258", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3266-2026%22", "url": "https://recallledger.net/recalls/device-z-3266-2026-medline-convenience-kits-1-major-pack-catalog-number-dynj81325a/"}, {"id": "fda-device-z-3265-2026", "source": "FDA", "category": "device", "recall_number": "Z-3265-2026", "title": "Medline Convenience Kits:  1) PEDS SINUS PACK recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) PEDS SINUS PACK, Catalog Number: DYNJ02516G;   2) SINUS PACK-LF, Catalog Number: DYNJ0342705J;   3) NASAL-LF, Catalog Number: DYNJ40094G;   4) ENT PACK, Catalog Number: DYNJ50699F;   5) EENT PACK, Catalog Number: DYNJ83219", "reason": "The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "695 kits", "codes": "1) DYNJ02516G, UDI-DI: 10889942295234(each), 40889942295235(case), Lot Number: 22HME611; 2) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23GMI728; 3) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23EME909; 4) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMG752; 5) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMB449; 6) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23AMI951; 7) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22KMD941; 8) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22JMC071; 9) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22FMD388; 10) DYNJ40094G, UDI-DI: 10195327170813(each), 40195327170814(case), Lot Number: 23HMA901; 11) DYNJ50699F, UDI-DI: 10193489826555(each), 40193489826556(case), Lot Number: 23HMA420; 12) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23GBH079; 13) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23FBB663; 14) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23DBS195; 15) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 22LBG199", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3265-2026%22", "url": "https://recallledger.net/recalls/device-z-3265-2026-medline-convenience-kits-1-peds-sinus-pack-catalog-number-dynj025/"}, {"id": "fda-device-z-3264-2026", "source": "FDA", "category": "device", "recall_number": "Z-3264-2026", "title": "PRO+ 40\" MRS SURFACE recall (Baxter Healthcare Corporation)", "product": "PRO+ 40\" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14", "reason": "There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-18", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "6 units", "codes": "Serial Number: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3264-2026%22", "url": "https://recallledger.net/recalls/device-z-3264-2026-pro-40-mrs-surface-mattress-with-advanced-microclimate-technology/"}, {"id": "fda-device-z-3263-2026", "source": "FDA", "category": "device", "recall_number": "Z-3263-2026", "title": "PRO+ 36\" MRS SURFACE recall (Baxter Healthcare Corporation)", "product": "PRO+ 36\" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13", "reason": "There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-18", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "824 units", "codes": "Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3263-2026%22", "url": "https://recallledger.net/recalls/device-z-3263-2026-pro-36-mrs-surface-mattress-with-advanced-microclimate-technology/"}, {"id": "fda-device-z-3262-2026", "source": "FDA", "category": "device", "recall_number": "Z-3262-2026", "title": "PRO+ MRS SURFACE FOR VERSACARE recall (Baxter Healthcare Corporation)", "product": "PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08", "reason": "There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-18", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "169 units", "codes": "Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3262-2026%22", "url": "https://recallledger.net/recalls/device-z-3262-2026-pro-mrs-surface-for-versacare-mattress-with-advanced-microclimate-te/"}, {"id": "fda-device-z-3258-2026", "source": "FDA", "category": "device", "recall_number": "Z-3258-2026", "title": "Cardioroot Woven Collagen Coated Vascular Graft recall (INTERVASCULAR, SAS)", "product": "Cardioroot Woven Collagen Coated Vascular Graft;  Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;", "reason": "Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).", "hazard_level": "Class II", "company": "INTERVASCULAR, SAS", "company_location": "La Ciotat Cedex, France", "date": "2026-08-12", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jordan, Kenya, Kosovo, Kuwait, Latvia, Luxembourg, Malaysia, Mauritius, Monaco, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Yemen.", "states": [], "nationwide": true, "quantity": "16329 (3880 US, 12449 OUS)", "codes": "1. Model Number: HEWROOT0024; UDI-DI: 00384401013884; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;  2. Model Number: HEWROOT0026;  UDI-DI: 00384401013891; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;  3. Model Number: HEWROOT0028;  UDI-DI: 00384401013907; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;  4. Model Number: HEWROOT0030;  UDI-DI: 00384401013914; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;  5. Model Number: HEWROOT0032; UDI-DI: 00384401013921; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;  6. Model Number: HEWROOT0034; UDI-DI: 00384401013938; Serial/Lot Numbers: All CARDIOROOT Woven products within labeled shelf life;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3258-2026%22", "url": "https://recallledger.net/recalls/device-z-3258-2026-cardioroot-woven-collagen-coated-vascular-graft-model-numbers-1-he/"}, {"id": "fda-device-z-3257-2026", "source": "FDA", "category": "device", "recall_number": "Z-3257-2026", "title": "Brand Name: VOLARA System  Product Name: VOLARA recall (Baxter Healthcare Corporation)", "product": "Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number: M08594A  Software Version: N/A  Product Description: VOLARA, HOMECARE, NORTH AMERICA  Component: No", "reason": "Contamination within the release test equipment flow path could have affected the accuracy of the  nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-03", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Colorado and Florida.", "states": ["CO", "FL"], "nationwide": true, "quantity": "2", "codes": "Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3257-2026%22", "url": "https://recallledger.net/recalls/device-z-3257-2026-brand-name-volara-system-product-name-volara-hc-na-a-model-catal/"}, {"id": "fda-device-z-3256-2026", "source": "FDA", "category": "device", "recall_number": "Z-3256-2026", "title": "REF: 81-030415  Myocardial Probe Non-Pyrogenic recall (DeRoyal Industries Inc)", "product": "REF: 81-030415  Myocardial Probe Non-Pyrogenic , 400 Series", "reason": "Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.", "hazard_level": "Class II", "company": "DeRoyal Industries Inc", "company_location": "Powell, TN, United States", "date": "2026-08-20", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of LA,MO, MD, TN, UT.", "states": ["LA", "MD", "MO", "TN", "UT"], "nationwide": true, "quantity": "7 cases, 140 units", "codes": "DI: 00749756046077/Lot # 63426754", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3256-2026%22", "url": "https://recallledger.net/recalls/device-z-3256-2026-ref-81-030415-myocardial-probe-non-pyrogenic-400-series/"}, {"id": "fda-device-z-3255-2026", "source": "FDA", "category": "device", "recall_number": "Z-3255-2026", "title": "Presource Convenience Kits:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Convenience Kits:  1) KIT, USGPIV                   , Catalog Number: PVMHIVMHD;   2) KIT, USGPIV                   , Catalog Number: PVMHIVM14;   3) KIT, USGPIV                   , Catalog Number: PVMHIVM15", "reason": "The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.", "states": ["FL", "KY", "MO", "NC", "OH", "TX"], "nationwide": true, "quantity": "9480 kits", "codes": "1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20                            ; 2) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 3) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 4) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5129488                       ; 5) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 6) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 7) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5182660                       ; 8) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 9) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398                       ; 10) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074                       ; 11) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 12) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188102                       ; 13) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5199118                       ; 14) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103                       ; 15) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818                       ; 16) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5150160                       ; 17) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818                       ; 18) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5210853                       ; 19) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5248375                       ; 20) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5276968                       ; 21) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797                       ; 22) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5279226                       ; 23) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797                       ; 24) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5307185                       ; 25) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5310701                       ; 26) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 6051588                       ; 27) PVMHIVM14, UDI-DI: 10198956165434(each), 50198956165432(case), Lot Number: 5126398                       ; 28) PVMHIVM15, UDI-DI: 10198956184459(each), 50198956184457(case), Lot Number: 5129058", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3255-2026%22", "url": "https://recallledger.net/recalls/device-z-3255-2026-presource-convenience-kits-1-kit-usgpiv-catalo/"}, {"id": "fda-device-z-3254-2026", "source": "FDA", "category": "device", "recall_number": "Z-3254-2026", "title": "Presource Convenience Kits:  1) KIT recall (Cardinal Health 200, LLC)", "product": "Presource Convenience Kits:  1) KIT, PRE OP                   , Catalog Number: AMN548616A;   2) KIT, NICU ADMIT NEW HAN       , Catalog Number: BA1DH0116B;   3) KIT, PRE PROCEDURE            , Catalog Number: IVSJV8302E;   4) KIT, IV SUPPLIES              , Catalog Number: IVS3223531;   5) KIT, IV SUPPLIES              , Catalog Number: IVS3223532;   6) KIT, IV SUPPLIES              , Catalog Number: IVS3223533;   7) KIT, IV SUPPLIES              , Catalog Number: IVS3223534;   8) KIT, IV SUPPLIES              , Catalog Number: IVS3223535;   9) KIT, IV SUPPLIES              , Catalog Number: IVS322358M;   10) KIT, IV SUPPLIES              , Catalog Number: IVS322358N;   11) KIT, IV SUPPLIES              , Catalog Number: IVS322358O;   12) KIT, PATIENT ADMISSIONS       , Catalog Number: AMN333032A;   13) KIT, C SECTION                , Catalog Number: MAT42267AL;   14) KIT, C SECTION                , Catalog Number: MAT4226725;   15) KIT, VAGINAL DELIVERY         , Catalog Number: MAT422677G;   16) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226792;   17) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226793;   18) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226794;   19) KIT, VAGINAL DELIVERY         , Catalog Number: MAT4226795", "reason": "The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.", "states": ["FL", "KY", "MO", "NC", "OH", "TX"], "nationwide": true, "quantity": "17503 kits", "codes": "1) AMN548616A, UDI-DI: 10197106721834(each), 10197106721834(case), Lot Number: 4249818                       ; 2) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5124984                       ; 3) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488                       ; 4) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5129488                       ; 5) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 6) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 7) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212                       ; 8) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 9) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211985                       ; 10) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 11) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 12) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5188103                       ; 13) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5211212                       ; 14) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5246952                       ; 15) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 16) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 17) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168                       ; 18) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5155824                       ; 19) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 5279226                       ; 20) BA1DH0116B, UDI-DI: 10198956006331(each), 10198956006331(case), Lot Number: 6062168                       ; 21) BA1DH0116B, UDI-DI: 0(each), 0(case), Lot Number: 6051588                       ; 22) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 23) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 24) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 25) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5124984                       ; 26) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 27) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 28) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5188103                       ; 29) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5195818                       ; 30) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211907                       ; 31) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 32) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211212                       ; 33) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 34) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226                       ; 35) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 36) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5211985                       ; 37) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 6037918                       ; 38) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5129488                       ; 39) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5155824                       ; 40) IVSJV8302E, UDI-DI: 10198956022683(each), 10198956022683(case), Lot Number: 5279226                       ; 41) IVS3223531, UDI-DI: 10198956173941(each), 10198956173941(case), Lot Number: 5124984                       ; 42) IVS3223532, UDI-DI: 10198956173958(each), 10198956173958(case), Lot Number: 5124984                       ; 43) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5188103                       ; 44) IVS3223533, UDI-DI: 10198956362536(each), 10198956362536(case), Lot Number: 5211985                       ; 45) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5129488                       ; 46) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5155824                       ; 47) IVS3223534, UDI-DI: 10198956470347(each), 10198956470347(case), Lot Number: 5310701                       ; 48) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 5188103                       ; 49) IVS3223535, UDI-DI: 10198956527010(each), 10198956527010(case), Lot Number: 60622168                      ; 50) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 51) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4248961                       ; 52) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 53) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 54) IVS322358M, UDI-DI: 10195594809362(each), 10195594809362(case), Lot Number: 4249818                       ; 55) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984                       ; 56) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 4249818                       ; 57) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5124984                       ; 58) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488                       ; 59) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 60) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 61) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5195818                       ; 62) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 63) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5188103                       ; 64) IVS322358N, UDI-DI: 10198956106086(each), 10198956106086(case), Lot Number: 5129488                       ; 65) IVS322358O, UDI-DI: 10198956517073(each), 10198956517073(case), Lot Number: 6051588                       ; 66) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5248375                       ; 67) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623                       ; 68) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5309623                       ; 69) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5310701                       ; 70) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 6051588                       ; 71) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5150160                       ; 72) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188102                       ; 73) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5188103                       ; 74) AMN333032A, UDI-DI: 10198956367791(each), 10198956367791(case), Lot Number: 5350797                       ; 75) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398                       ; 76) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5126398                       ; 77) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5181074                       ; 78) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102                       ; 79) MAT42267AL, UDI-DI: 10198956120129(each), 10198956120129(case), Lot Number: 5188102                       ; 80) MAT42267AL, UDI-DI: 5276968                       (each), 10198956120129(case), Lot Number: 10198956120129; 81) MAT4226725, UDI-DI: 5126398                       (each), 10198956181557(case), Lot Number: 10198956181557; 82) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 83) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 84) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5129058                       ; 85) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5126398                       ; 86) MAT422677G, UDI-DI: 10198956120136(each), 10198956120136(case), Lot Number: 5210853                       ; 87) MAT4226792, UDI-DI: 10198956207974(each), 10198956207974(case), Lot Number: 5129058                       ; 88) MAT4226793, UDI-DI: 10198956426405(each), 10198956426405(case), Lot Number: 5350797                       ; 89) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5309623                       ; 90) MAT4226794, UDI-DI: 10198956484559(each), 10198956484559(case), Lot Number: 5310701                       ; 91) MAT4226795, UDI-DI: 10198956538023(each), 10198956538023(case), Lot Number: 6051588", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3254-2026%22", "url": "https://recallledger.net/recalls/device-z-3254-2026-presource-convenience-kits-1-kit-pre-op-catalo/"}, {"id": "fda-device-z-3250-2026", "source": "FDA", "category": "device", "recall_number": "Z-3250-2026", "title": "ForeSight Elite Tissue Oximetry Cable REF HEMFSM10  UDI-DI code: 00690103210927    The... recall (Becton, Dickinson and Company)", "product": "ForeSight Elite Tissue Oximetry Cable REF HEMFSM10  UDI-DI code: 00690103210927    The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The  ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.", "reason": "Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.", "hazard_level": "Class II", "company": "Becton, Dickinson and Company", "company_location": "Irvine, CA, United States", "date": "2026-08-11", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Grand Cayman.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "15,455 cables", "codes": "Catalog/Model Number: HEMFSM10 UDI-DI code: 00690103210927  Part Number: 10026986001 Serial Numbers: 1907004 1907003  Part Number: 10026986002 Serial Numbers: 1941066 1941067 1924040 1925006 1925003 1925004 1924039 1938085 1923033 1928009  Part Number: 10026986003 Serial Numbers: 1944199 1950029 2008008 2008010 2008042 2008046 2008043 2008047 2008045 2008049 1942006 2008009 1928057 1938088  Part Number: 10034992001 Serial Numbers: 21101894 21101342 21101444  Part Number: 10034992003 Serial Numbers: 21103817 21103821 21103822 21103690 21103691 21103689 21103594 21103621 21103632 21103633 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21103537 21103539 21103882 21103998 21104021 21104022 21104024 21104025 21103728 21103729 21103730 21103731 21103734 21103735 21103736 21103519 21103501 21103506 21103508 21103509 21103510 21103514 21103516 21103518 21103503 21103504 21103507 21103512 21103513 21103515 21103520 21103521 21103502 21103927 21103928 21105044 21104036 21104037 21104040 21104042 21103951 21103958 21103976 21103983 21104300 21104083 21104301 21103991 21103791 21103858 21103866 21103890 21104422 21104423 21104425 21104426 21104428 21104407 21104291 21104362 21104368 21104375 21104384 21104405 21104414 21103907 21103802 21103803 21103806 21104276 21103638 21104363 21103645 21103653 21103641 21103644 21103646 21103647 21103649 21103650 21103651 21103652 21103655 21103661 21103663 21103665 21103610 21103601 21103598 21103599 21103603 21103604 21103605 21104360 21103854 21103947 21103948 21103949 21103950 21103953 21103954 21103955 21103956 21104237 21104238 21104235 21104236 21104169 21104177 21103807 21103875 21103893 21103844 21104075 21104032 21103749 21103773 21103774 21103716 21103824 21103825 21103787 21103784 21103789 21103798 21103799 21103800 21104174 21103710 21103739 21103812 21103981 21104450 21103917 21103874 21103845 21103763 21103704 21103698 21103699 21103700 21103701 21103702 21103703 21103918 21102816 21104089 21103498 21103499 21103500 21103848 21103721 21103711 21104251 21104364 21104366 21104048 21104049 21104051 21104052 21104053 21104054 21104069 21104351 21104353 21103765 21104141 21104296 21104297 21104294 21104295 21103781 21103783 21103786 21103777 21103636 21103637 21103921 21103923 21104385 21104417 21104424 21104420 21104130 21104139 21104144 21103864 21103818 21103883 21104073 21104070 21103775 21103746 21103801 21104079 21104055 21104056 21103974 21103905 21103481 21104009 21104039 21104046 21104059 21104061 21104062 21104104 21104285 21103724 21103881 21103617 21103879 21103880 21104060 21104050 21104057 21104058 21104064 21104065 21104166 21104350 21104419 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21121622 21123793 21121640 21122403 21122407 21107262 21122417 21122400 21123916 21123797 21125551 21123933 21120964 21122168 21105371 21120877 21124841 21125572 21123878 21123905 21122402 21122420 21123883 21126217 21120155 21125952 21107078 21107079 21124608 21124237 21122415 21124690 21126205 21121549 21122424  Part Number: 10034992R20 Serial Number: 21123467  Part Number: 10034992R22 Serial Numbers: 1950008 21101279 1950005 21103218 2008006 1950006 21101630 21101264 21101913 21102229 21101883 21102076 21102048 21102065 21101512 21101391 21101488 21101504 21102086 21102049 21102082 21102083 21102060 21103090 21103095 21125102 21102535 21104643 21102534 21102296 21103094  Part Number: 10034992R23 Serial Numbers: 21127161 21127742 21126924 21127367 21126973 21127614 21127602 21127433 21127160 21127386 21127389 21127464 21127517 21126913 21127613 21127168 21127225 21127226 21127036 21127043 21127241 21127243 21127088  Part Number: 10034992R24 Serial Numbers: 21103437 21105101  Part Number: 10034992R26 Serial Numbers: 21128596 21128593 21128674 21127366 21127616 21129523 21129180 21127527 21128327 21128710 21129385 21126989 21127518 21129441 21127118 21128936 21129074 21129047 21128056 21129129 21129127 21128441 21128757 21129517 21127001 21128432 21129520 21126997 21129351 21128984 21128164 21128136 21128185 21128207 21128597 21128019 21128132 21128192 21128589 21128440 21128065 21128375 21130259 21128637 21128165 21128211 21130328 21128787 21130386 21128720 21128197 21128201 21128208 21129236 21128155 21128145 21130368 21130373 21128189 21128204 21127150 21127514 21128937 21128599 21128623 21127977 21128721 21128804 21128641 21128171 21128044 21128124 21128227 21129533 21128112 21129529 21128648 21129532 21129537 21129530 21130371 21129534 21128163 21128374 21128224 21128642 21129535 21130265 21130369 21128135 21130281 21128123 21128790 21128622 21130382 21130329 21127974 21128845 21128847 21130370 21128167 21128199 21130381 21128246 21130384 21128196 21128168 21128522 21130327 21128074 21127975 21128049 21128141 21128154 21130385  Part Number: 10034992R28 Serial Number: 31100810", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3250-2026%22", "url": "https://recallledger.net/recalls/device-z-3250-2026-foresight-elite-tissue-oximetry-cable-ref-hemfsm10-udi-di-code-00690/"}, {"id": "fda-device-z-3249-2026", "source": "FDA", "category": "device", "recall_number": "Z-3249-2026", "title": "Philips EPIQ Elite Diagnostic Ultrasound System  Model # 795234 recall (Philips Ultrasound, LLC)", "product": "Philips EPIQ Elite Diagnostic Ultrasound System  Model # 795234", "reason": "Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.", "hazard_level": "Class II", "company": "Philips Ultrasound, LLC", "company_location": "Bothell, WA, United States", "date": "2026-08-07", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, \tNY, OH, PA, SC, TN, TX, VA, WA, WI and the countries of Austria, Denmark, Finland, France, \tGermany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan\t, United Kingdom, Vietnam.", "states": ["AL", "CA", "CT", "FL", "GA", "KS", "MD", "MN", "NJ", "NY", "OH", "PA", "SC", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "219 units", "codes": "All Philips EPIQ Elite Ultrasound Systems running software version 14.0, UDI(s): (01)00884838102514 (01)00884838107540 (01)00884838114159 (01)00884838124912 (01)00884838128125", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3249-2026%22", "url": "https://recallledger.net/recalls/device-z-3249-2026-philips-epiq-elite-diagnostic-ultrasound-system-model-795234/"}, {"id": "fda-device-z-3248-2026", "source": "FDA", "category": "device", "recall_number": "Z-3248-2026", "title": "Brand Name: Pearle Vision 1 day  Product Name: recall (CooperVision, Inc.)", "product": "Brand Name: Pearle Vision 1 day  Product Name: (somofilcon A) Contact Lens  Model/Catalog Number: Pearle Vision 1 day", "reason": "A small number of lenses within the affected lot are of the incorrect power.", "hazard_level": "Class II", "company": "CooperVision, Inc.", "company_location": "West Henrietta, NY, United States", "date": "2026-08-12", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MN, OH, WI.", "states": ["MN", "OH", "WI"], "nationwide": true, "quantity": "3060", "codes": "Pearle Vision 1 day;  Carton Lot # 11727620152030; Blister Lot # CB132348;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3248-2026%22", "url": "https://recallledger.net/recalls/device-z-3248-2026-brand-name-pearle-vision-1-day-product-name-somofilcon-a-contact/"}, {"id": "fda-device-z-3247-2026", "source": "FDA", "category": "device", "recall_number": "Z-3247-2026", "title": "Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA. recall (Olympus Corporation of the Americas)", "product": "Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.", "reason": "Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.", "states": [], "nationwide": true, "quantity": "816 units", "codes": "Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3247-2026%22", "url": "https://recallledger.net/recalls/device-z-3247-2026-olympus-bicoag-hemostasis-probe-7fr-fixed-pin-connector-model-catalog/"}, {"id": "fda-device-z-3246-2026", "source": "FDA", "category": "device", "recall_number": "Z-3246-2026", "title": "Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA. recall (Olympus Corporation of the Americas)", "product": "Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.", "reason": "Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.", "states": [], "nationwide": true, "quantity": "2,142 units", "codes": "Lot Code: Model: CD-B620LA. UDI-DI: 00821925039483. Lot Numbers: All unexpired lots.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3246-2026%22", "url": "https://recallledger.net/recalls/device-z-3246-2026-olympus-bicoag-hemostasis-probe-7fr-coaxial-connector-model-catalog-n/"}, {"id": "fda-device-z-3245-2026", "source": "FDA", "category": "device", "recall_number": "Z-3245-2026", "title": "Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA. recall (Olympus Corporation of the Americas)", "product": "Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.", "reason": "Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.", "states": [], "nationwide": true, "quantity": "105 units", "codes": "Model Number: CD-B612LA. UDI-DI: 00821925039476. Lot Number: All unexpired lots.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3245-2026%22", "url": "https://recallledger.net/recalls/device-z-3245-2026-olympus-bicoag-hemostasis-probe-10fr-fixed-pin-connector-model-catalo/"}, {"id": "fda-device-z-3244-2026", "source": "FDA", "category": "device", "recall_number": "Z-3244-2026", "title": "Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA. recall (Olympus Corporation of the Americas)", "product": "Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.", "reason": "Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.", "states": [], "nationwide": true, "quantity": "404 units", "codes": "Model Number: CD-B610LA. UDI-DI: 00821925039469. Lot Numbers: All unexpired lots.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3244-2026%22", "url": "https://recallledger.net/recalls/device-z-3244-2026-olympus-bicoag-hemostasis-probe-10fr-coaxial-connector-model-catalog/"}, {"id": "fda-device-z-3243-2026", "source": "FDA", "category": "device", "recall_number": "Z-3243-2026", "title": "SmartPath to dStream for 1.5T recall (Philips North America Llc)", "product": "SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X;  Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "965", "codes": "1. Model Number (System): 781260 (1.5T) UDI-DI: 884838095076; Serial Numbers: 32953, 8750, 8554, 9013, 18574, 18801, 18988, 20211, 32923, 32778, 8156, 8752, 10139, 10164, 21379, 21175, 32445, 11100, 18583, 18746, 18761, 18853, 18965, 18986, 20003, 21138, 21349, 21384, 21748, 22144, 22266, 30037, 30139, 30146, 32223, 32458, 33044, 33045, 33220, 33246, 33716, 72250, 5572, 8240, 8734, 8808, 8985, 10183, 12030, 20282, 21466, 32643, 8713, 8917, 10087, 10130, 18673, 18701, 18803, 32283, 22220, 8087, 8215, 8923, 13026, 22127, 32467, 8427, 10528, 8862, 21333, 21710, 21768, 22255, 22256, 22257, 21554, 22070, 32049, 5425, 5447, 5484, 5536, 5539, 5550, 8001, 8084, 8096, 8110, 8175, 8263, 8315, 8318, 8321, 8387, 8401, 8407, 8476, 8486, 8559, 8601, 8611, 8642, 8704, 8804, 8885, 9020, 9024, 10008, 10033, 10061, 10075, 10117, 10170, 10174, 10191, 10717, 11000, 11031, 11062, 11102, 11108, 12121, 18013, 18565, 18631, 18690, 18697, 18894, 18906, 18938, 18957, 20057, 20070, 20160, 21015, 21018, 21020, 21082, 21453, 21814, 21932, 21979, 22194, 30097, 32099, 32134, 32163, 32164, 32176, 32333, 32334, 32340, 32341, 32454, 32636, 32710, 32752, 39018, 39031, 39103, 5499, 5505, 8657, 21296, 32680, 10029, 18987, 8054, 8350, 11064, 11072, 12053, 13011, 18575, 18718, 18720, 18940, 20032, 20055, 20206, 20295, 21004, 21087, 21091, 21141, 21184, 21200, 21210, 21223, 21247, 21261, 21312, 21347, 21451, 21555, 21576, 21582, 21611, 21680, 21691, 21694, 21737, 21739, 21755, 21863, 21878, 21912, 21942, 22017, 22018, 22086, 22093, 22103, 22171, 22240, 30132, 30239, 32140, 32158, 32285, 32441, 32449, 32822, 33023, 33051, 33106, 33126, 33179, 39005, 72081, 8213, 5466, 5537, 5546, 8045, 8311, 8395, 8424, 8431, 8641, 8667, 8712, 8786, 8840, 10102, 10185, 10220, 10457, 10552, 10554, 11017, 11046, 12036, 13001, 18069, 18101, 18509, 18511, 18548, 18655, 18788, 18970, 20111, 20132, 20165, 20196, 20413, 21032, 21362, 21551, 21565, 21623, 21746, 21809, 21890, 21892, 22044, 22055, 22182, 22296, 22299, 30033, 32264, 32316, 32478, 32492, 32506, 32670, 32805, 32849, 32990, 33100, 39037, 72239, 72243, 5511, 8012, 8057, 8060, 8094, 8309, 8481, 8517, 8531, 8561, 8711, 8724, 8843, 8857, 8887, 8896, 8949, 10007, 10151, 10498, 10513, 10719, 10906, 10913, 11005, 11042, 11091, 12055, 12114, 12120, 13029, 13046, 13047, 13062, 13073, 18017, 18107, 18524, 18670, 18704, 18929, 18954, 20002, 20011, 20035, 20187, 20195, 20209, 20237, 20263, 20278, 20288, 20302, 21089, 21129, 21182, 21209, 21213, 21222, 21249, 21278, 21326, 21355, 21403, 21448, 21482, 21519, 21560, 21579, 21583, 21640, 21697, 21759, 21780, 21792, 21969, 21987, 22013, 22031, 22098, 22123, 22157, 22175, 22184, 32132, 32217, 32236, 32258, 39009, 21804, 13069, 33352, 22237, 33062, 8091, 10230, 11022, 12169, 18610, 18800, 18948, 21067, 21481, 32709, 33215, 8639, 8686, 18663, 18699, 21019, 21023, 21359, 32119, 32742, 8086, 8292, 10543, 21591, 22189, 32573, 32145, 21994, 21995, 10086, 10556, 8983, 18985, 8166, 8723, 10161, 10530, 22301, 22342, 32391, 8168, 8451, 21498, 18512, 21929, 22152, 21143, 21612, 22233, 22273, 22285, 8616, 20112, 32311, 32513, 33198, 33366, 10570, 11018, 8354, 8694, 9006, 32200, 5479, 8485, 8550, 8746, 8779, 8799, 9032, 10461, 10716, 12047, 21133, 21294, 21577, 32839, 32845, 11085, 12134, 21438, 22100, 22137, 32094, 32147, 32221, 32296, 32374, 32405, 32059, 32180, 8392, 12115, 20182, 22107, 32359, 32245, 8492, 8895, 10079, 20151, 20152, 20198, 21084, 21454, 21880, 32807, 21880, 5475, 8100, 8352, 8560, 8578, 8630, 8760, 8772, 8835, 8906, 8971, 8975, 9001, 10036, 10196, 10482, 10703, 12033, 12034, 18558, 18726, 20226, 20303, 21108, 21290, 21664, 21665, 21788, 32131, 32174, 33385;  2. Model Number (System): 782112 (1.5T) UDI-DI: 884838098886; Serial Numbers: 18857, 21252, 21684, 30313, 32250, 8266, 8552, 18776, 21771, 21803, 22048, 30058, 30089, 32106, 32400, 32487, 32827, 32897, 33000, 33103, 33189, 33275, 33371, 33404, 33494, 33545, 33547, 33565, 33568, 33749, 33751, 18942, 20224, 21495, 21608, 21726, 22247, 32295, 32673, 32762, 33019, 32724, 30054, 32229, 32265, 32418, 32419, 32558, 32596, 32803, 33033, 33248, 33249, 33470, 33647, 72204, 72208, 22141, 8798, 10169, 10190, 10474, 10521, 12029, 13021, 13024, 18810, 21077, 21090, 21158, 21685, 21740, 22027, 39106, 8298, 18714, 18510, 32469, 21940, 32539, 8573, 10128, 18995, 20099, 20159, 21433, 21893, 22290, 32457, 32577, 32580, 32661, 32719, 32725, 32798, 33082, 75012, 8109, 8876, 10222, 18520, 18651, 18892, 18950, 20171, 21205, 21212, 21298, 21513, 21906, 21939, 22328, 32244, 32348, 32355, 32375, 22051, 22298, 30145, 32412, 32690, 33218, 33635, 33061, 8433, 18707, 30273, 32287, 32624, 33639, 32133, 21164, 32327, 33217, 10028, 21708, 13023, 21127, 21297, 33048, 72275, 32188, 32363, 32364, 32426, 22267, 22173, 32610, 32613, 32799, 32859, 32654, 39070, 21463, 32519, 33338, 10221, 20204, 39021, 22045;  3. Model Number (System): 782146 (1.5T) UDI-DI: 884838108691; Serial Numbers: 32679, 33002, 33480, 33570, 30308, 33611, 32251, 22251, 13013, 21990, 32407, 32683, 8935, 20414, 32116;  4. Model Number (System): 782145 (3.0T) UDI-DI: 884838108684; Serial Numbers: 34256, 38295, 74041, 34144, 17377, 38127, 38313, 73004, 23029, 24062, 34208, 17435, 38276;  5. Model Number (System): 781270 (XR and 3.0T) UDI-DI: 884838095083; Serial Numbers: 17536, 17212, 17508, 24013, 38184, 23011, 17290, 34060, 38366, 17434, 38013, 38109, 17302, 17429, 17006, 17378, 17386, 35073, 38062, 17533, 17590, 34111, 38235, 17204, 17292, 17339, 17415, 17416, 17436, 17447, 23030, 24055, 34032, 34142, 34145, 34152, 34211, 35044, 38037, 38040, 38192, 38202, 38317, 17247, 17265, 17268, 17286, 17353, 17367, 17389, 17425, 17509, 17517, 17572, 17580, 24022, 24036, 34001, 34058, 35020, 35078, 38001, 38020, 38135, 38224, 17524, 23026, 24095, 34083, 34107, 34236, 34249, 35060, 17222, 17242, 17245, 17250, 17299, 17308, 17342, 17357, 17388, 17399, 17493, 17499, 17556, 17559, 17564, 17594, 23034, 24047, 24109, 24110, 24111, 24117, 24134, 34036, 34090, 34096, 34221, 35027, 35046, 35048, 35053, 38005, 38006, 38015, 38032, 38041, 38161, 38168, 17344, 17495, 17570, 17615, 24020, 24133, 34067, 34076, 34292, 38263, 17428, 23036, 38026, 38131, 38134, 17550, 24145, 38217, 38225, 17237, 34250, 38138, 17352, 17274, 34037, 34080, 35047, 38116, 17326, 17172, 17490, 24007, 38126, 17356, 38111, 24107, 38065, 38259, 38300, 38023, 38102, 74011, 17206, 17240, 17284, 17313, 17375, 17459, 17516, 24058, 24076, 34019, 34223, 35019, 35031, 35040;  6. Model Number (System): 782113 (XR and 3.0T) UDI-DI: 884838098909; Serial Numbers: 17449, 17455, 24154, 17470, 34059, 34262, 34056, 24052, 38106, 38066, 38082, 24097, 34172, 38049, 38070, 38142, 17238, 17372, 24135, 34143, 38354, 74036, 35070, 34072, 35041, 38105, 17271, 17346, 24021, 24093, 24146, 34117, 34127, 34128, 34129, 34153, 34202, 35045, 35059, 38094, 38290, 38311, 38310, 17560, 38114, 38166, 38261, 38042, 38281, 34110, 38117, 17521, 38010, 34130, 34304, 38219, 38222, 17307, 38075, 17384, 17461;  7. Model Number (System): 782129 (XR and 3.0T) UDI-DI: 884838105805; Serial Numbers: 34055, 38195;  8. Model Number (System): 782118 (Ingenia Elition X) UDI-DI: 884838099746; Serial Numbers: 71019, 71025, 42072, 42054, 42194, 85676, 42113, 42085, 42049, 42098, 42158, 42159, 85655, 85665;  9. Model Number (System): 782144 (Ingenia Elition X); UDI-DI: 884838108677; Serial Numbers: 71278, 42250, 71508, 71366;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3243-2026%22", "url": "https://recallledger.net/recalls/device-z-3243-2026-smartpath-to-dstream-for-1-5t-smartpath-to-dstream-for-3-0t-smartpat/"}, {"id": "fda-device-z-3242-2026", "source": "FDA", "category": "device", "recall_number": "Z-3242-2026", "title": "MR 7700 and Upgrade to MR 7700 recall (Philips North America Llc)", "product": "MR 7700 and Upgrade to MR 7700;  Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "37", "codes": "1. Model Number (REF): 782120; UDI-DI: 884838104112; Serial Numbers: 65002, 65003, 65014, 65015, 65050, 65029, 65056, 65018, 65021, 65035, 65038, 65000, 65025, 65006, 65008, 65043;  2. Model Number (REF): 782153; UDI-DI: 884838112858; Serial Numbers: 68011, 68022, 68031, 68014, 68012, 68009, 68033, 68053, 68023;  3. Model Number (REF): 782130; UDI-DI: 884838104402; Serial Numbers: 45007, 45052, 45043, 45044, 45552, 71616, 42164, 42066, 42104, 42248, 45263, 71532;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3242-2026%22", "url": "https://recallledger.net/recalls/device-z-3242-2026-mr-7700-and-upgrade-to-mr-7700-model-number-ref-1-782120-2-782/"}, {"id": "fda-device-z-3241-2026", "source": "FDA", "category": "device", "recall_number": "Z-3241-2026", "title": "MR 5300  Model Number recall (Philips North America Llc)", "product": "MR 5300  Model Number (REF): 1. 782110, 2. 782152;", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "611", "codes": "1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636, 63638, 63666, 63668, 63675, 63687, 63689, 63690, 63695, 63696, 63729, 63730, 63742, 63763, 63765, 63774, 63787, 63806, 63829, 63686, 63193, 63257, 63431, 63583, 63592, 63123, 63155, 63474, 63576, 63416, 63748, 63337, 63456, 63046, 63157, 63357, 63569, 63000, 63325, 63504, 63506, 63104, 63110, 63115, 63186, 63248, 63250, 63252, 63343, 63344, 63586, 63785, 63820, 63821, 63328, 63664, 63771, 63457, 63070, 63356, 63011, 63013, 63022, 63028, 63083, 63095, 63107, 63202, 63292, 63365, 63432, 63490, 63499, 63500, 63594, 63031, 63217, 63219, 63220, 63221, 63271, 63309, 63025, 63125, 63211, 63451, 63508, 63541, 63559, 63623, 63745, 63019, 63034, 63058, 63084, 63168, 63218, 63374, 63443, 63510, 63057, 63063, 63493, 63513, 63564, 63612, 63684, 63719, 63812, 63366, 63372, 63026, 63074, 63093, 63099, 63109, 63111, 63112, 63130, 63169, 63175, 63176, 63177, 63178, 63188, 63210, 63223, 63224, 63228, 63229, 63240, 63312, 63333, 63341, 63342, 63389, 63408, 63413, 63428, 63466, 63483, 63487, 63523, 63531, 63532, 63533, 63557, 63566, 63567, 63571, 63596, 63598, 63602, 63614, 63618, 63619, 63632, 63650, 63665, 63672, 63673, 63677, 63732, 63749, 63035, 63041, 63043, 63047, 63062, 63090, 63100, 63128, 63136, 63140, 63141, 63150, 63152, 63160, 63162, 63172, 63173, 63182, 63222, 63238, 63244, 63253, 63258, 63363, 63367, 63370, 63393, 63394, 63126, 63323, 63558, 63080, 63699, 63514, 63388, 63410, 63411, 63723, 63311, 63375, 63507, 63159, 63396, 63122, 63068, 63433, 63001, 63784, 63679, 63409, 63756, 63762, 63434, 63259, 63379, 63277, 63301, 63187, 63464, 63758, 63759, 63098, 63134, 63326, 63355, 63418, 63561, 63562, 63624, 63032, 63036, 63069, 63139, 63437, 63438, 63439, 63610, 63700, 63708, 63709, 63710, 63733, 63738, 63746, 63786, 63103, 63164, 63534, 63563, 63589, 63631, 63127, 63603, 63720, 63482, 63489, 63494, 63498, 63547, 63555, 63106, 63108, 63402, 63475, 63698, 63775, 63776, 63822, 63825, 63273, 63424, 63626, 63397, 63398, 63445, 63006, 63008, 63009, 63015, 63016, 63024, 63030, 63042, 63044, 63049, 63053, 63105, 63135, 63138, 63151, 63153, 63154, 63492, 63352, 63059, 63497, 63681, 63488, 63503, 63722, 63071, 63072, 63294, 63295, 63296, 63297, 63299, 63340, 63361, 63455, 63519, 63724, 63770, 63067, 63174, 63191, 63197, 63449, 63674, 63800, 63798, 63039, 63165, 63318, 63330, 63380, 63440, 63012, 63014, 63018, 63029, 63033, 63087, 63196, 63203, 63204, 63316, 63520, 63587, 63477, 63530, 63740, 63201, 63400, 63401, 63446, 63453, 63478, 63502, 63550, 63597, 63605, 63616, 63704, 63747, 63757, 63780, 63823, 63824, 63833, 63119, 63442, 63461, 63570, 63766, 63767, 63810;  2. Model Number (REF): 782152; UDI-DI: N/A; Serial Numbers: 69304, 69349, 69098, 69101, 69250, 69318, 69321, 69338, 69238, 69239, 69024, 69026, 69034, 69039, 69046, 69081, 69083, 69105, 69151, 69235, 69023, 69037, 69041, 69066, 69112, 69152, 69233, 69302, 69299, 69193, 69194, 69241, 69287, 69320, 69070, 69071, 69106, 69110, 69127, 69161, 69360, 69366, 69044, 69045, 69048, 69116, 69286, 69300, 69351, 69055, 69073, 69075, 69086, 69191, 69207, 69243, 69252, 69258, 69260, 69261, 69262, 69264, 69268, 69270, 69288, 69290, 69295, 69296, 69297, 69000, 69003, 69008, 69010, 69011, 69014, 69015, 69017, 69030, 69147, 69312, 69325, 69326, 69327, 69328, 69329, 69330, 69331, 69332, 69333, 69334, 69289, 69340, 69115, 69200, 69201, 69263, 69154, 69342, 69348, 69170, 69135, 69139, 69197, 69271, 69277, 69133, 69185, 69215, 69234, 69038, 69189, 69053, 69058, 69065, 69078, 69085, 69092, 69103, 69122, 69123, 69169, 69177, 69179, 69216, 69220, 69221, 69224, 69225, 69228, 69229, 69267, 69301, 69305, 69306, 69307, 69313, 69314, 69323, 69343, 69365, 69316, 69027, 69096, 69097, 69186, 69212, 69240, 69254, 69255, 69063, 69064, 69069, 69080, 69095, 69126, 69176, 69315, 69005, 69067, 69175, 69198, 69247, 69294, 69298, 69336;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3241-2026%22", "url": "https://recallledger.net/recalls/device-z-3241-2026-mr-5300-model-number-ref-1-782110-2-782152/"}, {"id": "fda-device-z-3240-2026", "source": "FDA", "category": "device", "recall_number": "Z-3240-2026", "title": "Name recall (Philips North America Llc)", "product": "Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "82", "codes": "1. Intera 1.5T  Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 20431, 18898, 20429, 18669, 18981, 18982, 18734, 18763, 20427, 18842, 18654, 18878, 18566, 18618, 18752, 20409, 18748, 18743, 18657, 20424, 18755, 18908, 18501, 18646, 18768, 18516, 18554, 18616, 18723, 18725, 18784;  2. Intera 1.5T; Model Numbers (REF): 781295; UDI-DI: N/A; Serial Numbers: 30138, 30297, 30314, 30210, 30137, 30173, 30179, 30104, 30105, 30290, 30208, 30051, 30035, 30143, 30109, 30063, 30237, 30135;  3. Intera 1.5T Achieva IT Nova; Model Numbers (REF): (781175); UDI-DI: N/A; Serial Number: 15003;   4. Intera 1.5T Achieva Nova; Model Numbers (REF): 781172; UDI-DI: N/A; Serial Numbers: 12105, 12049, 12079, 12001, 12086, 12099, 12046, 12057, 12081, 12075, 12078, 12106;  5. Intera 1.5T Achieva Nova-Dual; Model Numbers (REF): 781173; UDI-DI: N/A; Serial Numbers: 13006, 13017, 13058, 13012, 13048, 13049;  6. Intera 1.5T Omni/Stellar; Model Numbers (REF): 781104; UDI-DI: N/A; Serial Number: 10403;  7. Intera Achieva 1.5T Pulsar; Model Numbers (REF): 781171; UDI-DI: 884838088108; Serial Numbers: 11044, 11009, 11029, 11043, 11040, 11039, 11090;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3240-2026%22", "url": "https://recallledger.net/recalls/device-z-3240-2026-name-model-number-1-intera-1-5t-781195-2-intera-1-5t-781295/"}, {"id": "fda-device-z-3239-2026", "source": "FDA", "category": "device", "recall_number": "Z-3239-2026", "title": "Ingenia Elition S and Ingenia Elition X recall (Philips North America Llc)", "product": "Ingenia Elition S and Ingenia Elition X;  Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "596", "codes": "1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109;  2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399, 46400, 46201, 46202, 46220, 46225, 46352, 46310, 46234, 46205, 46207, 46209, 46211, 46214, 46215, 46226, 46228, 46235, 46237, 46239, 46240, 46241, 46282, 46281, 46297, 46304, 46317, 46354, 46212, 61010, 46206, 46362, 46393, 46348, 46217, 46289, 46233, 46353, 46213, 46218, 46222, 46384, 46224, 46265, 46286, 46390, 46263, 46307, 46387, 46403;  3. Model Numbers (REF): 782137(S); UDI-DI: 884838108615; Serial Numbers: 64004, 64008, 64024, 64028, 64031, 64046, 64047, 64002, 64003, 64009, 64013, 64034, 64045, 64050, 64030, 64029, 64049, 64051;  4. Model Numbers (REF): 781358(X); UDI-DI: 884838088115; Serial Numbers: 45107, 45142, 45145, 45216, 45241, 45284, 45121, 45257, 45154, 45193, 45253, 45106, 45131, 45259, 45298, 45300, 45302, 45313, 45330, 45344, 45345, 45349, 45352, 45359, 45360, 45363, 45367, 45368, 45370, 45371, 45372, 45377, 45378, 45381, 45390, 45391, 45394, 45396, 45397, 45409, 45410, 45411, 45412, 45416, 45417, 45419, 45421, 45428, 45432, 45434, 45435, 45437, 45439, 45442, 45443, 45444, 45446, 45447, 45448, 45450, 45451, 45456, 45459, 45461, 45463, 45467, 45469, 45470, 45471, 45473, 45474, 45476, 45480, 45265, 45293, 45369, 45159, 45374, 45040, 45065, 45070, 45260, 45319, 45000, 45039, 45047, 45080, 45109, 45137, 45188, 45210, 45262, 45339, 45139, 45025, 45031, 45114, 45151, 45160, 45176, 45248, 45274, 45276, 45282, 45392, 45438, 45441, 45138, 45041, 45046, 45050, 45061, 45064, 45066, 45076, 45077, 45102, 45118, 45141, 45149, 45163, 45170, 45185, 45189, 45211, 45212, 45224, 45250, 45268, 45272, 45280, 45281, 45314, 45323, 45332, 45340, 45295, 45122, 45123, 45169, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45354, 45267, 45085, 45311, 45312, 45156, 45157, 45292, 45009, 45181, 45217, 45289, 45348, 45362, 45219, 45094, 45180, 45067, 45183, 45393, 45408, 45426, 45081, 45095, 45376, 45058, 45140, 45294, 45042, 45195, 45197, 45242, 45350, 45174, 45165, 45382, 45158, 45177, 45153, 45088, 45111, 45128, 45134, 45218, 45002, 45010, 45027, 45051, 45068, 45082, 45087, 45124, 45133, 45147, 45161, 45164, 45178, 45237, 45238, 45245, 45247, 45261, 45269, 45277, 45296, 45315, 45321, 45322, 45337, 45338, 45343, 45353, 45355, 45356, 45357, 45364, 45414, 45429, 45155;  5. Model Numbers (REF): 782107(X); UDI-DI: 884838098336; Serial Numbers: 62016, 62189, 45525, 45551, 45546, 45590, 62158, 62180, 62103, 62104, 62106, 62107, 62108, 62109, 62110, 62111, 62112, 62113, 62114, 62115, 62117, 62118, 62119, 62120, 62122, 62124, 62125, 62126, 62127, 62132, 62133, 62138, 62142, 62162, 62163, 62164, 62167, 62170, 62173, 62176, 62187, 62196, 62200, 62201, 62202, 62203, 62204, 62209, 62210, 62211, 62213, 62216, 62223, 62225, 62226, 62227, 62228, 62230, 62232, 62239, 62243, 62244, 62245, 62247, 45555, 62130, 62018, 62087, 62091, 45568, 62207, 62219, 45523, 45536, 45542, 62214, 45540, 45577, 62046, 62100, 62139, 62217, 45566, 45562, 45567, 45587, 45595, 62012, 62029, 62031, 62128, 62154, 62155, 62166, 62184, 62190, 62205, 62206, 62240, 62254, 62255, 62256, 62264, 62265, 45596, 45599, 62021, 62186, 45594, 45528, 45529, 45538, 45560, 45564, 62024, 62041, 62047, 62048, 62070, 62084, 62137, 62179, 62168, 45501, 45511, 45516, 45517, 45518, 45556, 45565, 62017, 62039, 62090, 62236, 62231, 45554, 62145, 62146, 62224, 62258, 62259, 62260, 62261, 62262, 62263, 62266, 45520, 45583, 62066, 62212, 62038, 62156, 62157, 62215, 62140, 62188, 62148, 45544, 45579, 62035, 62050, 62058, 62059, 62061, 62062, 62065, 62071, 62097, 62134, 45524, 45550, 62042, 45521, 45600, 45504, 45531, 45563, 45570, 62026, 62152, 62183, 62208, 62218, 62241;  6. Model Numbers (REF): 782119(X); UDI-DI: 884838104129; Serial Numbers: 66002, 66001;  7. Model Numbers (REF): 782136(X); UDI-DI: 884838108608; Serial Numbers: 28514, 28576, 28569, 28502, 28536, 28567, 28588, 28613, 28585, 28533, 28544, 28573, 28615, 28629, 28555, 28504, 28516, 28517, 28524, 28531, 28537, 28563, 28575, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28554, 28635, 28636, 28506, 28509, 28565, 28581, 28625, 28628, 28638, 28527, 28550, 28586, 28604, 28616;  8. Model Numbers (REF): 782158(X); UDI-DI: 884838115699; Serial Number: 90017;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3239-2026%22", "url": "https://recallledger.net/recalls/device-z-3239-2026-ingenia-elition-s-and-ingenia-elition-x-model-numbers-ref-1-7813/"}, {"id": "fda-device-z-3238-2026", "source": "FDA", "category": "device", "recall_number": "Z-3238-2026", "title": "Ingenia 3.0T and Ingenia 3.0T CX recall (Philips North America Llc)", "product": "Ingenia 3.0T and Ingenia 3.0T CX;  Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "1447", "codes": "1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, 71928, 71930, 71935, 71944, 71946, 71951, 71952, 71957, 71958, 71973, 71987, 71988, 85010, 85024, 85026, 85028, 85037, 85042, 85048, 85049, 85050, 85061, 85065, 85073, 85075, 85079, 85096, 85098, 85099, 85105, 85111, 85112, 85127, 85141, 85152, 85153, 85160, 85162, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85184, 85198, 85200, 85204, 85218, 85220, 85226, 85230, 85242, 85243, 85247, 85249, 85251, 85259, 85263, 85268, 85269, 85270, 85272, 85280, 85282, 85283, 85284, 85285, 85288, 85290, 85291, 85294, 85300, 85303, 85305, 85309, 85310, 85311, 85313, 85314, 85323, 85325, 85329, 85332, 85333, 85334, 85335, 85336, 85339, 85344, 85345, 85346, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85369, 85370, 85371, 85373, 85374, 85375, 85376, 85380, 85382, 85383, 85384, 85385, 85386, 85387, 85389, 85390, 85392, 85397, 85398, 85399, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85415, 85416, 85417, 85418, 85419, 85420, 85422, 85425, 85426, 85427, 85429, 85430, 85431, 85432, 85433, 85434, 85439, 85440, 85442, 85447, 85448, 85449, 85453, 85454, 85455, 85456, 85457, 85458, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, 71372, 71649, 71581, 71582, 71748, 85143, 71405, 71373, 85265, 71047, 71662, 71678, 71891, 85189, 71267, 71353, 71402, 71457, 85450, 85451, 71474, 71338, 71418, 71924, 71991, 85202, 85306, 71437, 71003, 71020, 71023, 71173, 71192, 71283, 71288, 71298, 71315, 71337, 71359, 71363, 71370, 71396, 71400, 71440, 71501, 71576, 71590, 71603, 71751, 71791, 71838, 71874, 85025, 85161, 85253, 85301, 85319, 85342, 85391, 71346, 71362, 71910, 71983, 85063, 85183, 85205, 85206, 85216, 85341, 71334, 71409, 71476, 85023, 71061, 71106, 71162, 71165, 71181, 71280, 71349, 71351, 71357, 71410, 71428, 71460, 71477, 71512, 71518, 71643, 71677, 71691, 71717, 71743, 71750, 71762, 71763, 71842, 71854, 71900, 71966, 71967, 85122, 85140, 85147, 85149, 85190, 85203, 85210, 85224, 85318, 71367, 71461, 71545, 85241, 85302, 85348, 85372, 85459, 71423, 71177, 71326, 71424, 71681, 71758, 71863, 71892, 85057, 85245, 85246, 85250, 85286, 71001, 71002, 71004, 71007, 71012, 71013, 71014, 71035, 71037, 71039, 71056, 71070, 71093, 71095, 71154, 71155, 71174, 71175, 71183, 71211, 71228, 71268, 71269, 71282, 71341, 71347, 71361, 71401, 71411, 71413, 71416, 71425, 71429, 71450, 71463, 71489, 71498, 71527, 71571, 71587, 71589, 71592, 71635, 71641, 71652, 71655, 71659, 71670, 71676, 71682, 71686, 71694, 71760, 71766, 71767, 71772, 71778, 71801, 71802, 71825, 71844, 71851, 71864, 71869, 71878, 71879, 71880, 71881, 71882, 71897, 71972, 71992, 85022, 85038, 85064, 85069, 85074, 85076, 85083, 85121, 85124, 85217, 85377, 85378, 85381, 85396, 85400, 71086, 71343, 71671, 71679, 85428, 71107, 85166, 71058, 71078, 71176, 71263, 71299, 71307, 71321, 71387, 71575, 71625, 71640, 71799, 71852, 85181, 85187, 85312, 85330, 85365, 71172, 71195, 71790, 71948, 71996, 85004, 85136, 85223, 85317, 85109, 71956, 85232, 85304, 85021, 71159, 71364, 71380, 71563, 71953, 71170, 71296, 71781, 85213, 71097, 71722, 71335, 71919, 85148, 85367, 71302, 85366, 71150, 71188, 71225, 71360, 71634, 71665, 71884, 85009, 71510, 71746, 85018, 71648, 85236, 85260, 85368, 71220, 71227, 71272, 71350, 71451, 71522, 71700, 85012, 85054, 85316, 85388, 85414, 71077, 71204, 71365, 71398, 85091, 71478, 71618, 71826, 71669, 71764, 71833, 71867, 71270, 71051, 71231, 71604, 71650, 71689, 71823, 71895, 85059, 85321, 85340, 71600, 71848, 71305, 71445, 71566, 71018, 71040, 71072, 71189, 71197, 71198, 71224, 71332, 71384, 71434, 71442, 71448, 71486, 71496, 71597, 71623, 71644, 71645, 71703, 71706, 71737, 71752, 71871, 85081, 85114, 85142, 71314, 71583, 71808, 71916, 71291, 71304, 71368, 71371, 71711, 71756, 71822, 71860, 71911, 71931, 71936, 85123, 85125, 85185, 85193, 71333, 71377, 71386, 71524, 71785, 71789, 71986, 85019, 85209, 85295, 85322, 71352, 71426, 71977, 85020, 71215, 71285, 71287, 71308, 71318, 71354, 71459, 71490, 71534, 85101, 71010, 71016, 71022, 71029, 71045, 71062, 71064, 71065, 71071, 71073, 71153, 71187, 71190, 71194, 71200, 71203, 71213, 71275, 71277, 71317, 71319, 71331, 71336, 71369, 71376, 71379, 71382, 71388, 71397, 71399, 71407, 71415, 71444, 71456, 71483, 71495, 71528, 71529, 71569, 71570, 71584, 71599, 71667, 71675, 71680, 71683, 71721, 71732, 71735, 71796, 71805, 71810, 71827, 71829, 71858, 71893, 71914, 71982, 85067, 85094, 85154, 85221, 85275, 85278, 85436, 71436, 85222, 71544;  2. Model Numbers (REF): 781377(3.0T); UDI-DI: 884838009813; Serial Numbers: 42175, 42190, 42221, 42231, 42283, 42291, 42339, 42439, 42466, 42186, 42147, 42171, 42183, 42206, 42213, 42448, 42243, 42251, 42280, 42326, 42343, 42362, 42367, 42380, 42398, 42436, 42444, 42445, 42446, 42452, 42453, 42454, 42458, 42459, 42463, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42560, 42561, 42565, 42570, 42042, 42239, 42178, 42041, 42092, 42005, 42013, 42015, 42021, 42027, 42028, 42061, 42073, 42081, 42082, 42090, 42097, 42107, 42130, 42138, 42141, 42143, 42145, 42216, 42279, 42292, 42315, 42044, 42089, 42232, 42272, 42026, 42047, 42110, 42146, 42191, 42192, 42285, 42364, 42407, 42426, 42136, 42137, 42199, 42275, 42014, 42056, 42074, 42093, 42095, 42103, 42112, 42115, 42121, 42128, 42133, 42161, 42162, 42179, 42203, 42205, 42222, 42233, 42237, 42245, 42249, 42252, 42253, 42257, 42260, 42261, 42262, 42263, 42278, 42282, 42289, 42300, 42309, 42314, 42331, 42333, 42337, 42345, 42347, 42349, 42361, 42378, 42383, 42392, 42412, 42420, 42421, 42422, 42432, 42442, 42428, 42087, 42120, 42170, 42201, 42267, 42401, 42449, 42294, 42019, 42390, 42451, 42135, 42209, 42008, 42236, 42353, 42355, 42455, 42256, 42043, 42438, 42265, 42321, 42018, 42012, 42065, 42079, 42132, 42134, 42176, 42303, 42338, 42399, 42419, 42264, 42131, 42204, 42055, 42220, 42358, 42413, 42001, 42006, 42034, 42036, 42038, 42040, 42045, 42050, 42052, 42053, 42067, 42068, 42076, 42083, 42096, 42099, 42100, 42101, 42102, 42111, 42116, 42117, 42119, 42123, 42150, 42152, 42169, 42177, 42180, 42185, 42214, 42229, 42240, 42241, 42242, 42247, 42266, 42274, 42286, 42298, 42307, 42328, 42334, 42356, 42365, 42368, 42370, 42389, 42400, 42429, 42077, 42066;  3. Model Numbers (REF): 782103(3.0T); UDI-DI: 884838098299; Serial Numbers: 85724, 85667, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85650, 85656, 85657, 85658, 85659, 85660, 85662, 85692, 85710, 85715, 85721, 85722, 85725, 85727, 85729, 85735, 85738, 85739, 85740, 85743, 85745, 85746, 85747, 85748, 85749, 85756, 85696, 85620, 85608, 85614, 85755, 85672, 85673, 85674, 85720, 85730, 85732, 85762, 85693, 85619, 85718, 85600, 85607, 85616, 85617, 85707, 85613, 85611, 85612, 85615, 85703, 85719, 85666, 85664, 85700, 85643, 85644, 85761;  4. Model Numbers (REF): 781271(3.0T CX); UDI-DI: 884838068452; Serial Numbers: 78121, 78150, 78157, 78096, 78012, 78074, 78154, 78161, 78170, 78171, 78172, 78173, 78182, 78183, 78189, 78190, 78196, 78198, 78205, 78210, 78212, 78213, 78216, 78218, 78221, 78225, 78240, 78242, 78243, 78244, 78250, 78251, 78252, 78253, 78256, 78257, 78262, 78263, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78279, 78280, 78281, 78282, 78283, 78284, 78288, 78289, 78291, 78292, 78293, 78294, 78295, 78296, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 78078, 78224, 78098, 78003, 78065, 78070, 78076, 78081, 78087, 78097, 78099, 78101, 78104, 78107, 78126, 78149, 78151, 78181, 78206, 78219, 78264, 78064, 78106, 78187, 78000, 78007, 78010, 78015, 78018, 78019, 78021, 78023, 78029, 78031, 78032, 78038, 78039, 78043, 78048, 78049, 78051, 78062, 78068, 78072, 78082, 78083, 78084, 78088, 78089, 78091, 78095, 78100, 78109, 78111, 78117, 78127, 78129, 78132, 78133, 78139, 78140, 78155, 78203, 78207, 78214, 78222, 78223, 78011, 78013, 78014, 78034, 78044, 78046, 78047, 78058, 78060, 78066, 78071, 78073, 78075, 78077, 78086, 78092, 78102, 78110, 78118, 78120, 78128, 78135, 78137, 78138, 78141, 78142, 78158, 78162, 78164, 78180, 78188, 78193, 78194, 78209, 78215, 78227, 78232, 78234, 78247, 78254, 78255, 78261, 78277, 78290, 78297, 78298, 78299, 78326, 78337, 78004, 78030, 78059, 78156, 78249, 78026, 78022;  5. Model Numbers (REF): 782105(3.0T CX); UDI-DI: 884838098312; Serial Numbers: 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78536, 78537, 78539, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78567, 78570, 78571, 78573, 78574, 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78532, 78535, 78538, 78540, 78541, 78542, 78543, 78544, 78552, 78566, 78568;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3238-2026%22", "url": "https://recallledger.net/recalls/device-z-3238-2026-ingenia-3-0t-and-ingenia-3-0t-cx-model-numbers-ref-1-781342-3-0t/"}, {"id": "fda-device-z-3237-2026", "source": "FDA", "category": "device", "recall_number": "Z-3237-2026", "title": "Ingenia Ambition S and Ingenia Ambition X recall (Philips North America Llc)", "product": "Ingenia Ambition S and Ingenia Ambition X;  Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "922", "codes": "1. Model Numbers (REF): 781359(S); UDI-DI: 884838090057; Serial Numbers: 48053, 48126, 48136, 48144, 48020, 48030, 48155, 48191, 48216, 48218, 48245, 48300, 48183, 48186, 48187, 48222, 48225, 48234, 48240, 48241, 48249, 48269, 48278, 48284, 48288, 48293, 48294, 48299, 48304, 48313, 48317, 48326, 48331, 48051, 48223, 48207, 48028, 48031, 48049, 48050, 48131, 48134, 48242, 48254, 48219, 48000, 48004, 48019, 48032, 48132, 48135, 48145, 48160, 48224, 48244, 48040, 48122, 48039, 48022, 48152, 48012, 48014, 48036, 48037, 48044, 48127, 48151, 48158, 48174, 48184, 48046, 48047, 48055, 48128, 48129, 48153, 48190, 48192, 48194, 48226, 48275, 48181, 48198, 48199, 48200, 48033, 48045, 48001, 48038, 48185, 48238, 48239, 48276, 48010, 48170, 48035, 48172, 48027, 48248, 48146, 48147, 48148, 48163, 48164, 48165, 48169, 48182, 48188, 48271, 48290, 48291, 48297, 48302, 48303, 48308, 48309, 48310, 48321, 48325, 48329, 48337, 48018, 48283, 48177, 48017, 48056, 48250, 48272, 48253, 48268, 48026, 48013, 48052, 48112, 48120, 48130, 48162, 48171, 48179, 48214, 48217, 48233, 48237, 48243, 48252, 48273, 48274, 48286, 48287, 48314, 48322, 48133, 48316;  2. Model Numbers (REF): 782108(S); UDI-DI: 884838098343; Serial Numbers: 48572, 48627, 48581, 48687, 48592, 48652, 48800, 48953, 48544, 48506, 48520, 48521, 48534, 48551, 48781, 48834, 48842, 48843, 48848, 48892, 48712, 48714, 48715, 48810, 48813, 48833, 48883, 48885, 48943, 48947, 48538, 48539, 48556, 48602, 48640, 48808, 48613, 48650, 48502, 48507, 48514, 48540, 48577, 48579, 48580, 48590, 48591, 48612, 48614, 48617, 48620, 48628, 48632, 48638, 48692, 48697, 48698, 48721, 48765, 48818, 48819, 48824, 48503, 48557, 48570, 48595, 48606, 48651, 48706, 48707, 48725, 48729, 48744, 48756, 48773, 48796, 48804, 48815, 48861, 48876, 48898, 48695, 48660, 48734, 48877, 48878, 48879, 48679, 48889, 48529, 48609, 48622, 48658, 48659, 48769, 48774, 48837, 48857, 48864, 48574, 48900, 48541, 48549, 48710, 48865, 48504, 48508, 48513, 48524, 48536, 48537, 48555, 48560, 48571, 48573, 48585, 48593, 48594, 48596, 48597, 48600, 48611, 48624, 48639, 48642, 48644, 48666, 48711, 48762, 48768, 48775, 48778, 48891, 48950, 48522, 48561, 48668, 48686, 48737, 48846, 48852, 48887, 48607, 48519, 48680, 48699, 48738, 48820, 48845, 48860, 48867, 48868, 48869, 48870, 48901, 48942, 48948, 48951, 48958, 48962, 48532, 48533, 48505, 48567, 48671, 48672, 48676, 48801, 48604, 48851, 48515, 48584, 48886, 48674, 48753, 48754, 48782, 48783, 48784, 48785, 48789, 48790, 48791, 48793, 48794, 48807, 48875, 48902, 48945, 48941, 48961, 48550, 48647, 48850, 48610, 48615, 48654, 48728, 48685, 48817, 48500, 48635, 48523, 48535, 48546, 48552, 48562, 48578, 48589, 48645, 48646, 48648, 48649, 48655, 48656, 48665, 48669, 48675, 48700, 48708, 48719, 48748, 48749, 48826, 48827, 48828, 48832, 48855, 48872, 48874, 48888, 48907, 48973, 48661, 48662, 48663, 48724, 48693, 48884, 48525, 48526, 48978;  3. Model Numbers (REF): 782139(S); UDI-DI: 884838108639; Serial Numbers: 29021, 29038, 29000, 29008, 29010, 29011, 29012, 29014, 29016, 29022, 29039, 29040, 29045, 29052, 29072, 29096, 29097, 29105, 29108, 29127, 29130, 29131, 29081, 29090, 29095, 29151, 29054, 29069, 29078, 29115, 29053, 29118, 29139, 29140, 29003, 29015, 29020, 29028, 29033, 29143, 29169, 29013, 29138, 29144, 29062, 29076, 29079, 29126, 29132, 29137, 29153, 29155, 29157, 29158, 29164, 29136, 29150, 29160, 29068, 29070, 29165, 29120, 29057, 29047, 29049, 29133, 29134, 29042, 29043, 29055, 29065, 29122;  4. Model Numbers (REF): 781356(X); UDI-DI: 884838090040; Serial Numbers: 47194, 47040, 47091, 47345, 47361, 47050, 47209, 47254, 47275, 47049, 47357, 47013, 47014, 47015, 47053, 47065, 47082, 47000, 47002, 47017, 47024, 47035, 47047, 47056, 47058, 47074, 47078, 47089, 47192, 47225, 47337, 47226, 47227, 47341, 47307, 47364, 47365, 47372, 47284, 47350, 47057, 47075, 47088, 47174, 47175, 47193, 47052, 47085, 47262, 47328, 47342, 47384, 47064, 47244, 47219, 47220, 47298, 47247, 47329, 47096, 47207, 47283, 47190, 47264, 47034, 47202, 47315, 47332, 47367, 47385, 47016, 47269, 47382, 47352, 47021, 47001, 47032, 47041, 47248, 47255, 47311, 47272, 47306, 47077, 47009, 47080, 47083, 47242, 47245, 47302, 47310, 47312, 47006, 47007, 47011, 47018, 47022, 47025, 47028, 47033, 47044, 47045, 47054, 47060, 47061, 47062, 47066, 47071, 47084, 47090, 47093, 47095, 47176, 47183, 47185, 47196, 47198, 47203, 47204, 47205, 47208, 47210, 47216, 47251, 47280, 47291, 47316, 47323, 47324, 47325, 47330, 47331, 47333, 47335, 47336, 47338, 47339, 47340, 47346, 47370, 47377, 47378, 47380, 47387;  5. Model Numbers (REF): 782109(X); UDI-DI: 884838098350; Serial Numbers: 47531, 47540, 47877, 47878, 47879, 47869, 47519, 47526, 47555, 47584, 47839, 47565, 47644, 47742, 47585, 47582, 47755, 47903, 47928, 47935, 47940, 47713, 47946, 47947, 47944, 47507, 47508, 47610, 47900, 47901, 47527, 47529, 47545, 47640, 47725, 47778, 47855, 47858, 47870, 47532, 47533, 47547, 47548, 47591, 47831, 47843, 47882, 47607, 47583, 47625, 47626, 47627, 47628, 47629, 47630, 47675, 47676, 47786, 47850, 47854, 47868, 47921, 47933, 47509, 47525, 47765, 47902, 47908, 47919, 47504, 47579, 47683, 47688, 47737, 47784, 47808, 47809, 47810, 47822, 47826, 47837, 47846, 47847, 47887, 47905, 47909, 47910, 47936, 47938, 47939, 47511, 47536, 47543, 47561, 47562, 47564, 47646, 47671, 47681, 47694, 47698, 47750, 47603, 47705, 47578, 47819, 47516, 47841, 47907, 47954, 47955, 47956, 47957, 47958, 47959, 47937, 47518, 47716, 47754, 47782, 47783, 47689, 47853, 47952, 47953, 47656, 47867, 47912, 47914, 47798, 47948, 47665, 47557, 47834, 47550, 47513, 47602, 47528, 47768, 47770, 47773, 47804, 47860, 47883, 47889, 47785, 47791, 47934, 47635, 47788, 47906, 47923, 47696, 47747, 47806, 47865, 47535, 47614, 47617, 47651, 47652, 47660, 47661, 47662, 47663, 47718, 47720, 47721, 47727, 47728, 47729, 47730, 47731, 47779, 47851, 47560, 47546, 47563, 47697, 47797, 47811, 47845, 47904, 47566, 47597, 47679, 47695, 47753, 47577, 47701, 47738, 47514, 47632, 47792, 47538, 47554, 47574, 47575, 47576, 47621, 47642, 47659, 47672, 47739, 47740, 47759, 47763, 47771, 47794, 47799, 47802, 47813, 47814, 47823, 47835, 47859, 47861, 47888, 47891, 47896, 47929, 47931, 47950;  6. Model Numbers (REF): 782138(X); UDI-DI: 884838108622; Serial Numbers: 49004, 49049, 49106, 49136, 49063, 49075, 49183, 49197, 49246, 49269, 49272, 49020, 49021, 49022, 49027, 49029, 49030, 49031, 49033, 49034, 49036, 49037, 49038, 49039, 49043, 49055, 49060, 49068, 49069, 49140, 49189, 49190, 49191, 49192, 49194, 49195, 49196, 49202, 49203, 49219, 49221, 49223, 49230, 49251, 49254, 49255, 49045, 49058, 49071, 49130, 49153, 49158, 49180, 49181, 49270, 49145, 49161, 49168, 49156, 49228, 49047, 49098, 49099, 49147, 49148, 49154, 49220, 49222, 49232, 49268, 49206, 49290, 49008, 49009, 49092, 49093, 49094, 49146, 49072, 49080, 49087, 49104, 49105, 49109, 49173, 49210, 49231, 49233;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3237-2026%22", "url": "https://recallledger.net/recalls/device-z-3237-2026-ingenia-ambition-s-and-ingenia-ambition-x-model-numbers-ref-1-78/"}, {"id": "fda-device-z-3236-2026", "source": "FDA", "category": "device", "recall_number": "Z-3236-2026", "title": "Ingenia 1.5T recall (Philips North America Llc)", "product": "Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S;  Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "2038", "codes": "1. Model Numbers (REF): 781315(1.5T); UDI-DI: 884838099715; Serial Numbers: 61019, 61140, 61080, 61067, 61091, 61114, 61028, 61039, 61040, 61041, 61000, 61002, 61003, 61006, 61009, 61017, 61032, 61058, 61065, 61066, 61074, 61075, 61097, 61106, 61124, 61001, 61004, 61011, 61023, 61025, 61026, 61034, 61035, 61042, 61046, 61115, 61078, 61015, 61119, 61005, 61020, 61043, 61085, 61088, 61036, 61052, 61057, 61061, 61068, 61069, 61070, 61072, 61095, 61117, 61125, 61126, 61129, 61130, 61027, 61108, 61109, 61131, 61144, 61107, 61138, 61142, 61102, 61103, 61014, 61018, 61016, 61038, 61073, 61079, 61082, 61084, 61092, 61093, 61096, 61022, 61044, 61049, 61050, 61053;  2. Model Numbers (REF): 781341(1.5T); UDI-DI: 884838055322; Serial Numbers: 87260, 70040, 70229, 70607, 70763, 84030, 84108, 84234, 84257, 84596, 87005, 87146, 70603, 70604, 70605, 70725, 70767, 70768, 70812, 70232, 70367, 70374, 70375, 70764, 70780, 84566, 84621, 84629, 84667, 87214, 87215, 70193, 70485, 70488, 70831, 70832, 70833, 70071, 70311, 84098, 84343, 84765, 70110, 70111, 70161, 70177, 70204, 70244, 70269, 70446, 70448, 70459, 70470, 70612, 70662, 70663, 70664, 70665, 70666, 70667, 70668, 70678, 70691, 70755, 70845, 70864, 70866, 70867, 70868, 70942, 70943, 70969, 84178, 84179, 84180, 84302, 84303, 84330, 84381, 84384, 84385, 84387, 84844, 84976, 87028, 87098, 87124, 87125, 87126, 87135, 87177, 87180, 87206, 87207, 87221, 87222, 87271, 87290, 87297, 84249, 84891, 70286, 70641, 70655, 70712, 70730, 70851, 84649, 84092, 84311, 84730, 84744, 84766, 84890, 84982, 84986, 87151, 87171, 87191, 70974, 70981, 70987, 70997, 84010, 84066, 84082, 84150, 84153, 84197, 84204, 84230, 84242, 84256, 84262, 84287, 84290, 84291, 84310, 84318, 84320, 84321, 84327, 84383, 84389, 84397, 84399, 84411, 84422, 84427, 84496, 84503, 84515, 84531, 84582, 84585, 84588, 84608, 84645, 84673, 84692, 84770, 84810, 84812, 84813, 84822, 84830, 84831, 84833, 84855, 84857, 84859, 84861, 84863, 84872, 84922, 84928, 84943, 84946, 84984, 84990, 84997, 87009, 87029, 87045, 87048, 87054, 87056, 87084, 87109, 87110, 87113, 87114, 87123, 87142, 87174, 87181, 87192, 87201, 87202, 87224, 87227, 87233, 87240, 87241, 87248, 87254, 87257, 87268, 87272, 87274, 87283, 87284, 87291, 87294, 87299, 87300, 87302, 87303, 87305, 87307, 87311, 87312, 87314, 87315, 87317, 87318, 87320, 87326, 87138, 84551, 70654, 84792, 87112, 84195, 70369, 70965, 70333, 70778, 84407, 84408, 84547, 84687, 70250, 70258, 84488, 87141, 84664, 70601, 87008, 70296, 70597, 70818, 70885, 70976, 70991, 84051, 84164, 84165, 84166, 84167, 84175, 84176, 84322, 84323, 84342, 84425, 84471, 84593, 84742, 87139, 87266, 84704, 84705, 70796, 84412, 70598, 84271, 84341, 84474, 84671, 84681, 84807, 84850, 84867, 84910, 84920, 84921, 87076, 70021, 70029, 70129, 70199, 70270, 70277, 70294, 70302, 70381, 70427, 70463, 70464, 70583, 70611, 70617, 70626, 70651, 70673, 70680, 70684, 70692, 70784, 70785, 70799, 70854, 70855, 70870, 70881, 70921, 70929, 70986, 70992, 70993, 84016, 84104, 84116, 84122, 84131, 84155, 84187, 84207, 84228, 84259, 84395, 84404, 84423, 84438, 84453, 84454, 84487, 84544, 84564, 84565, 84574, 84624, 84632, 84654, 84718, 84829, 84914, 84996, 87081, 87100, 87249, 87262, 84801, 84900, 84901, 70599, 70347, 70648, 70797, 84047, 84789, 87111, 70804, 84806, 70119, 70280, 70339, 70361, 70695, 70717, 70773, 70788, 70865, 70897, 70931, 70932, 70933, 70962, 70967, 84070, 84095, 84096, 84241, 84245, 84292, 84298, 84372, 84374, 84375, 84401, 84421, 84455, 84456, 84458, 84477, 84518, 84519, 84520, 84521, 84522, 84523, 84524, 84598, 84657, 84676, 84677, 84678, 84679, 84680, 84693, 84757, 84832, 84948, 84955, 87000, 87050, 87219, 87285, 87319, 84218, 70196, 70334, 70335, 70384, 70423, 70703, 70918, 70919, 84209, 84211, 84216, 84261, 84331, 84494, 84719, 84720, 87276, 87277, 87278, 87279, 87282, 87129, 87131, 87155, 87213, 87281, 70072, 70613, 70934, 70146, 70201, 70281, 70287, 70658, 84015, 87058, 70027, 70144, 70228, 70300, 70585, 70591, 70592, 70702, 70726, 70746, 70765, 70786, 70795, 70798, 70809, 70817, 70823, 70834, 70935, 70946, 70961, 84007, 84081, 84083, 84091, 84124, 84125, 84127, 84135, 84144, 84177, 84220, 84269, 84382, 84413, 84420, 84431, 84491, 84502, 84513, 84530, 84536, 84594, 84604, 84606, 84851, 84864, 84871, 84937, 84952, 84956, 84988, 84994, 84995, 87115, 87165, 87236, 70011, 70013, 70037, 70038, 70039, 70053, 70055, 70056, 70084, 70192, 70203, 70263, 70273, 70299, 70329, 70343, 70379, 70402, 70436, 70460, 70595, 70649, 70682, 70720, 70732, 70734, 70735, 70736, 70738, 70747, 70772, 70774, 70789, 70792, 70800, 70805, 70813, 70825, 70827, 70836, 70848, 70850, 70859, 70861, 70889, 70909, 70920, 70926, 70970, 84008, 84027, 84028, 84032, 84034, 84035, 84052, 84060, 84061, 84062, 84065, 84079, 84099, 84114, 84118, 84149, 84172, 84191, 84194, 84226, 84229, 84233, 84247, 84255, 84266, 84309, 84335, 84357, 84376, 84394, 84396, 84444, 84480, 84492, 84495, 84534, 84535, 84550, 84556, 84583, 84603, 84641, 84647, 84650, 84659, 84666, 84670, 84697, 84706, 84713, 84721, 84722, 84724, 84745, 84747, 84748, 84751, 84775, 84793, 84805, 84818, 84819, 84820, 84839, 84858, 84873, 84879, 84895, 84904, 84918, 84930, 84977, 87001, 87023, 87026, 87038, 87117, 87136, 87175, 87176, 87187, 87190, 87204, 87234, 87235, 87238, 87239, 87242, 87289, 87293, 84231, 84086, 84275, 84826, 84940, 87210, 70238, 70261, 70891, 84661, 84847, 87079, 84349, 84350, 84351, 84352, 84353, 84354, 84355, 84025, 84347, 70128, 70198, 70593, 84490, 87212, 84772, 84854, 87036, 87037, 84716, 70318, 87296, 70930, 84068, 70264, 70708, 70908, 84013, 84089, 84199, 84221, 84250, 84368, 84430, 84571, 84572, 84600, 84602, 84700, 84834, 84862, 84885, 84983, 84443, 84852, 70777, 70262, 70637, 70679, 70714, 70910, 70998, 84138, 84140, 84217, 84278, 84398, 70075, 70947, 70960, 84115, 84148, 84587, 84752, 87143, 87144, 70131, 70481, 70628, 70722, 84145, 70136, 84045, 84046, 70048, 70065, 70066, 70255, 70711, 87078, 87269, 70282, 84611, 70828, 84057, 84288, 84424, 70022, 70371, 70437, 70775, 70830, 84029, 84363, 84573, 84605, 84689, 87003, 87102, 70236, 70271, 84067, 84709, 84113, 84888, 70416, 70945, 84129, 87116, 70140, 70337, 70350, 70351, 70357, 70368, 70401, 70428, 70449, 70486, 70487, 70489, 70490, 70624, 70683, 70686, 70744, 70745, 70811, 70840, 70847, 70900, 70954, 70985, 84021, 84039, 84069, 84097, 84142, 84171, 84198, 84244, 84279, 84305, 84361, 84362, 84428, 84599, 84626, 84637, 84653, 84662, 84717, 84726, 84729, 84738, 84758, 84759, 84796, 84865, 84931, 84934, 84975, 84989, 87024, 87031, 87069, 87071, 87147, 87152, 87153, 87154, 87161, 87172, 87185, 87188, 87208, 87211, 87237, 87244, 87265, 87280, 70194, 70242, 70314, 70697, 70776, 70806, 70871, 70888, 84087, 84258, 84472, 84613, 84746, 84798, 84802, 87035, 87044, 87049, 87082, 87090, 87093, 70759, 70685, 70733, 70915, 84933, 70429, 70982, 84557, 70025, 70434, 70689, 70802, 84402, 84577, 84675, 70123, 70226, 70235, 70251, 70295, 70364, 70383, 70435, 70629, 70656, 70844, 70890, 70927, 70973, 84004, 84224, 84312, 84313, 84332, 84371, 84437, 84546, 84554, 84576, 84584, 84592, 84663, 84740, 84773, 84774, 84896, 87004, 87034, 87039, 87119, 87134, 87253, 70026, 70952, 84470, 70074, 70114, 70306, 70623, 70754, 70869, 84084, 84268, 84315, 87027, 70058, 70426, 70468, 70791, 70849, 84036, 84037, 84616, 84633, 84651, 84827, 84828, 84868, 87226, 70230, 84206, 84214, 84308, 84416, 84479, 84482, 84558, 84620, 84656, 84808, 84809, 84848, 70356, 70358, 70359, 70677, 70057, 70080, 70087, 70097, 70157, 70610, 70693, 70810, 84002, 84003, 84074, 84237, 84239, 84338, 84339, 84367, 84483, 84767, 84849, 84913, 84915, 84960, 84969, 87022, 87086, 87087, 87094, 87095, 87158, 87163, 87259, 70239, 87209, 70085, 70160, 70246, 70348, 70349, 70407, 70723, 70873, 70917, 87101, 70148, 70191, 70297, 70301, 70316, 70440, 70453, 70465, 70482, 70587, 70608, 70770, 70843, 70872, 70887, 70899, 70906, 70914, 70994, 84005, 84038, 84137, 84154, 84208, 84210, 84252, 84293, 84297, 84306, 84325, 84334, 84346, 84377, 84406, 84445, 84690, 84838, 84869, 87083, 87194, 70044, 70049, 70052, 70063, 70076, 70095, 70156, 70190, 70200, 70233, 70292, 70298, 70308, 70312, 70321, 70328, 70403, 70451, 70455, 70606, 70614, 70621, 70627, 70636, 70646, 70650, 70675, 70676, 70694, 70698, 70699, 70700, 70706, 70709, 70719, 70727, 70729, 70752, 70762, 70771, 70779, 70783, 70808, 70819, 70835, 70857, 70863, 70874, 70892, 70893, 70894, 70898, 70903, 70911, 70939, 70951, 70972, 84012, 84026, 84043, 84063, 84075, 84077, 84088, 84134, 84147, 84157, 84168, 84170, 84173, 84174, 84189, 84196, 84200, 84225, 84264, 84274, 84280, 84282, 84283, 84286, 84314, 84316, 84340, 84344, 84400, 84410, 84432, 84434, 84439, 84440, 84441, 84446, 84460, 84462, 84469, 84475, 84481, 84484, 84485, 84498, 84499, 84505, 84506, 84508, 84509, 84514, 84526, 84537, 84538, 84552, 84614, 84627, 84644, 84646, 84674, 84734, 84741, 84791, 84799, 84811, 84816, 84821, 84823, 84824, 84836, 84866, 84889, 84894, 84911, 84929, 84935, 84942, 84970, 84973, 84993, 87017, 87019, 87043, 87055, 87057, 87097, 87103, 87120, 87132, 87133, 87218, 87231, 87245, 70179, 70883, 84251, 84284, 84776, 84777, 84778, 84779, 84780, 84781, 84782, 84783, 70657, 70154, 70710, 87232, 87247;  3. Model Numbers (REF): 781396(1.5T); UDI-DI: 884838009820; Serial Numbers: 41175, 41176, 41007, 41039, 41127, 41157, 41256, 41350, 41132, 41186, 41230, 41268, 41359, 41441, 41521, 41584, 41204, 41449, 41151, 41518, 41524, 41610, 41615, 41617, 41618, 41619, 41509, 41591, 41045, 41108, 41180, 41314, 41366, 41397, 41486, 41519, 41436, 41070, 41351, 41010, 41016, 41029, 41052, 41071, 41084, 41112, 41125, 41131, 41141, 41142, 41160, 41178, 41192, 41210, 41211, 41228, 41240, 41283, 41335, 41338, 41368, 41380, 41381, 41388, 41389, 41395, 41417, 41442, 41454, 41473, 41538, 41540, 41561, 41009, 41050, 41113, 41272, 41480, 41087, 41093, 41096, 41129, 41163, 41184, 41193, 41213, 41217, 41220, 41246, 41257, 41267, 41352, 41365, 41399, 41494, 41502, 41522, 41545, 41049, 41060, 41068, 41074, 41106, 41117, 41124, 41126, 41128, 41133, 41136, 41153, 41243, 41280, 41292, 41298, 41299, 41357, 41408, 41435, 41437, 41452, 41493, 41496, 41507, 41513, 41543, 41544, 41549, 41558, 41559, 41565, 41570, 41571, 41115, 41405, 41560, 41020, 41169, 41188, 41293, 41458, 41466, 41467, 41474, 41013, 41100, 41140, 41190, 41214, 41249, 41301, 41450, 41461, 41304, 41075, 41562, 41164, 41219, 41296, 41331, 41394, 41111, 41594, 41407, 41476, 41477, 41479, 41003, 41162, 41172, 41185, 41191, 41254, 41255, 41498, 41515, 41138, 41259, 41440, 41531, 41329, 41478, 41146, 41318, 41355, 41371, 41376, 41423, 41453, 41548, 41000, 41006, 41015, 41021, 41022, 41028, 41035, 41037, 41044, 41048, 41057, 41059, 41066, 41067, 41077, 41083, 41092, 41094, 41095, 41097, 41098, 41134, 41148, 41149, 41154, 41158, 41166, 41171, 41195, 41197, 41198, 41203, 41205, 41206, 41208, 41209, 41212, 41221, 41222, 41237, 41250, 41251, 41260, 41265, 41278, 41290, 41294, 41305, 41313, 41358, 41406, 41409, 41415, 41418, 41420, 41421, 41426, 41429, 41463, 41481, 41482, 41495, 41511, 41512, 41514, 41517, 41525, 41532, 41551, 41552, 41555, 41569, 41580, 41224, 41238, 41319, 41526, 41118;  4. Model Numbers (REF): 782101(1.5T); UDI-DI: 884838098275; Serial Numbers: 87602, 87644, 87645, 87648, 87649, 87653, 87601, 87605, 87298, 87607, 87608, 87609, 87610, 87612, 87613, 87614, 87617, 87627, 87631, 87632, 87633, 87634, 87635, 87636, 87638, 87639, 87640, 87641, 87642, 87643, 87654, 87655;  5. Model Numbers (REF): 782115(1.5T); UDI-DI: 884838099043; Serial Numbers: 61250, 61281, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61213, 61214, 61280, 61299, 61341, 61292, 61358, 61385, 61266, 61201, 61210, 61212, 61217, 61227, 61350, 61403, 61417, 61264, 61273, 61192, 61193, 61246, 61206, 61208, 61219, 61248, 61249, 61265, 61269, 61328, 61337, 61257, 61425, 61303, 61306, 61316, 61320, 61321, 61348, 61349, 61354, 61355, 61356, 61357, 61360, 61378, 61404, 61419, 61420, 61421, 61332, 61175, 61181, 61182, 61183, 61188, 61199, 61200, 61204, 61218, 61220, 61224, 61268, 61270, 61289, 61295, 61300, 61334, 61338, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61400, 61408, 61409, 61410, 61411, 61413, 61422, 61428, 61177, 61180, 61184, 61185, 61187, 61189, 61191, 61205, 61209, 61221, 61222, 61225, 61229, 61230, 61237, 61243, 61245, 61253, 61262, 61263, 61275, 61279, 61313, 61314, 61315, 61336, 61288, 61352, 61416, 61179, 61258, 61359, 61304, 61380, 61145, 61196, 61381, 61426, 61407, 61415, 61427, 61232, 61223, 61298, 61195, 61226, 61351, 61333, 61339, 61252, 61234, 61203, 61235, 61329, 61241, 61326, 61327, 61176, 61198, 61202, 61211, 61240, 61256, 61283, 61285, 61290, 61293, 61294, 61302, 61406, 61207, 61233, 61242, 61282, 61331, 61342, 61383, 61384, 61310, 61311, 61312, 61259, 61260;  6. Model Numbers (REF): 782140(1.5T); UDI-DI: 884838108646; Serial Numbers: 45607, 45606, 45608, 45609, 45610, 45601;  7. Model Numbers (REF): 781261(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77008, 77000, 77004, 77001, 77019, 77010, 77014, 77007, 77016;  8. Model Numbers (REF): 781262(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77131, 77070, 77124, 77144, 77172, 77074, 77048, 77178, 77031, 77134, 77050, 77051, 77060, 77194, 77034, 77037, 77038, 77057, 77072, 77075, 77078, 77084, 77085, 77086, 77092, 77101, 77110, 77156, 77157, 77111, 77119, 77167, 77183, 77185, 77187, 77188, 77195, 77196, 77198, 77199, 77202, 77052, 77053, 77054, 77055, 77056, 77064, 77065, 77066, 77067, 77068, 77069, 77105, 77125, 77126, 77135, 77136, 77137, 77138, 77139, 77148, 77141, 77030, 77032, 77033, 77036, 77042, 77043, 77044, 77049, 77059, 77061, 77071, 77083, 77087, 77088, 77090, 77091, 77093, 77097, 77100, 77106, 77107, 77115, 77118, 77120, 77121, 77128, 77155, 77161, 77162, 77190, 77140, 77201, 77166, 77045, 77063, 77109, 77117, 77123, 77147, 77113, 77168, 77169, 77122, 77154, 77046, 77130, 77062, 77039, 77040, 77114, 77127, 77160, 77150, 77041, 77193, 77203;  9. Model Numbers (REF): 781347(1.5T S); UDI-DI: 884838068421; Serial Numbers: 81003, 81050, 81051, 81090, 81111, 81151, 81010, 81028, 81030, 81035, 81063, 81106, 81093, 81105, 81116, 81004, 81009, 81011, 81017, 81018, 81019, 81020, 81023, 81024, 81031, 81037, 81041, 81055, 81056, 81060, 81064, 81070, 81074, 81078, 81112, 81115, 81118, 81122, 81138, 81139, 81140, 81146, 81147, 81153, 81156, 81158, 81175, 81184, 81013, 81044, 81005, 81007, 81040, 81047, 81059, 81167, 81170, 81171, 81008, 81108, 81148, 81133, 81164, 81001, 81026, 81086, 81079, 81014, 81061, 81065, 81085, 81091, 81092, 81032, 81043, 81129, 81131, 81149, 81155, 81162, 81165, 81172, 81084, 81087, 81088, 81094, 81095, 81127, 81132, 81174, 81157, 81176, 81071, 81052, 81067, 81038, 81179, 81185, 81117, 81173, 81154, 81025, 81097, 81045, 81075, 81076, 81077, 81096, 81114, 81124, 81126, 81145, 81159, 81152, 81029, 81034, 81042, 81049, 81058, 81080, 81113, 81123, 81128, 81137, 81178;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3236-2026%22", "url": "https://recallledger.net/recalls/device-z-3236-2026-ingenia-1-5t-ingenia-1-5t-cx-and-ingenia-1-5t-s-model-numbers-ref/"}, {"id": "fda-device-z-3235-2026", "source": "FDA", "category": "device", "recall_number": "Z-3235-2026", "title": "Evolution upgrade 1.5T and Evolution upgrade 3.0T recall (Philips North America Llc)", "product": "Evolution upgrade 1.5T and Evolution upgrade 3.0T;  Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "91", "codes": "1. Model Numbers (REF): 782116 (1.5T); UDI-DI: 884838099722; Serial Numbers: 41130, 70284, 41491, 41196, 41520, 70068, 41024, 41025, 41051, 41139, 41144, 41286, 41327, 41349, 41424, 41432, 41433, 70099, 70202, 81073, 41344, 41229, 41457, 41497, 41413, 41080, 41527, 70205, 70589, 81021, 41179, 41189, 70949;   2. Model Numbers (REF): 782148 (1.5T); UDI-DI: 884838108714; Serial Numbers: 41523, 70630, 70966, 84102, 84473, 84825, 41031, 41043, 41085, 41284, 41392, 41553, 70596, 81006, 70644, 41488, 41534, 70454, 41167, 41375, 41446, 70652, 41011, 70590, 70195, 84628;  3. Model Numbers (REF): 782117 (3.0T); UDI-DI: 884838099739; Serial Numbers: 42246, 85713, 42029, 71774, 85668, 85680, 85685, 85694, 42023, 42024, 42078, 42217, 42402, 71348, 71044, 85698, 85146, 42003, 85663, 85677;  4. Model Numbers (REF): 782143 (3.0T); UDI-DI: N/A; Serial Numbers: 71815, 42440, 71389, 85688, 85690, 85649, 42193, 42366, 85683, 85697, 85701, 85708;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3235-2026%22", "url": "https://recallledger.net/recalls/device-z-3235-2026-evolution-upgrade-1-5t-and-evolution-upgrade-3-0t-model-numbers-ref/"}, {"id": "fda-device-z-3234-2026", "source": "FDA", "category": "device", "recall_number": "Z-3234-2026", "title": "Achieva XR recall (Philips North America Llc)", "product": "Achieva XR;  Model Numbers (REF): 1. 781153, 2. 781253;", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "15", "codes": "1. Model Numbers (REF): 781153; UDI-DI: N/A; Serial Numbers: 23035, 23003, 23021, 23028;   2. Model Numbers (REF): 781253; UDI-DI: N/A; Serial Numbers: 35028, 35068, 35083, 35074, 35049, 35004, 35006, 35011, 35015, 35050, 35076;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3234-2026%22", "url": "https://recallledger.net/recalls/device-z-3234-2026-achieva-xr-model-numbers-ref-1-781153-2-781253/"}, {"id": "fda-device-z-3233-2026", "source": "FDA", "category": "device", "recall_number": "Z-3233-2026", "title": "Achieva 3.0T recall (Philips North America Llc)", "product": "Achieva 3.0T;  Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "210", "codes": "1. Model Numbers (REF): 781177; UDI-DI: N/A; Serial Numbers: 17144, 17376, 17448, 24049, 17099, 24138, 24060, 17607, 17079, 17146, 17189, 17379, 17469, 17270, 17432, 17279, 17233, 17295, 17446, 17362, 24068, 24096, 17139, 24037, 24099, 17535, 24079, 17030, 17043, 17056, 17114, 17149, 17161, 17167, 17170, 17179, 17216, 17217, 17235, 17251, 17316, 17319, 17365, 17453, 17494, 17523, 17558, 17561, 24038, 24070, 24089;  2. Model Numbers (REF): 781277; UDI-DI: N/A; Serial Numbers: 34289, 34213, 34276, 34113, 34123, 34239, 34264, 34274, 34285, 34095, 34138, 34305, 34118, 34106, 34159, 34241, 34263, 34139, 34002, 34029, 34034, 34071, 34201;  3. Model Numbers (REF): 781278; UDI-DI: N/A; Serial Numbers: 38326, 38346, 38043, 38098, 38108, 38152, 38157, 38194, 38210, 38212, 38215, 38231, 38233, 38236, 38238, 38240, 38267, 38269, 38270, 38271, 38284, 38312, 38321, 38328, 38332, 38338, 38339, 38340, 38344, 38349, 38367, 38370, 38401, 38402, 38405, 38407, 38408, 38412, 38415, 38420, 38421, 38423, 38425, 38426, 38427, 38430, 38431, 38432, 38433, 38437, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 38288, 38079, 38139, 38228, 38145, 38034, 38251, 38278, 38207, 38061, 38086, 38095, 38115, 38133, 38017, 38064, 38112, 38143, 38160, 38183, 38229, 38256, 38296, 38297, 38315, 38331, 38272, 38322, 38323, 38337, 38345, 38077, 38200, 38268, 38090, 38188, 38093, 38012, 38099, 38003, 38057, 38072, 38085, 38016, 38033, 38091, 38103, 38173, 38341, 38232;  4. Model Numbers (REF): 781344;  UDI-DI: N/A; Serial Numbers: 73005, 73008, 73009, 73006, 73010;  5. Model Numbers (REF): 781345; UDI-DI: N/A; Serial Numbers: 74027, 74035, 74039, 74047, 74052, 74001, 74010, 74026, 74046, 74005, 74007, 74021, 74030, 74040, 74044, 74048, 74032, 74037;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3233-2026%22", "url": "https://recallledger.net/recalls/device-z-3233-2026-achieva-3-0t-model-numbers-ref-1-781177-2-781277-3-781278-4/"}, {"id": "fda-device-z-3232-2026", "source": "FDA", "category": "device", "recall_number": "Z-3232-2026", "title": "Achieva 1.5T recall (Philips North America Llc)", "product": "Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system;  Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);", "reason": "A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;", "states": ["GA"], "nationwide": true, "quantity": "387", "codes": "1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215, 21397, 21431, 21689, 21986, 22021, 22243, 21427, 22117, 22326, 21076, 21104, 21183, 21264, 21272, 21284, 21321, 21334, 21351, 21405, 21455, 21479, 21494, 21508, 21572, 21574, 21589, 21666, 21776, 21805, 21868, 21879, 21935, 21957, 21968, 21993, 22001, 22004, 22066, 22130, 22136, 22155, 22207, 22258;  2. Model Numbers (REF): 781343 (Achieva 1.5T); UDI-DI: 884838055292; Serial Numbers: 72020, 72104, 72137, 72138, 72146, 72157, 72160, 72170, 72171, 72179, 72183, 72185, 72200, 72223, 72233, 72238, 72251, 72269, 72013, 72111, 72113, 72231, 72235, 72270, 72271, 72273, 72286, 72079, 72083, 72109, 72120, 72122, 72123, 72124, 72126, 72139, 72141, 72142, 72147, 72150, 72247, 72007, 72156, 72101, 72116, 72117, 72180, 72197, 72267, 72189, 72008, 72080, 72036, 72052, 72057, 72103, 72134, 72143, 72144, 72145, 72151, 72186, 72199, 72217, 72224, 72227, 72228, 72236, 72253, 72254, 72255, 72256, 72257, 72258, 72259, 72260, 72264, 72278, 72279, 72296, 72297, 72298, 72299, 72304, 72029, 72129, 72153, 72175, 72194, 72207, 72281, 72290, 72301, 72302, 72310, 72311, 72316, 72320, 72321, 72326, 72329, 72075, 72076, 72261, 72022, 72047, 72100, 72154, 72159, 72240, 72285, 72287, 72317, 72324, 72015, 72016, 72023, 72071, 72074, 72205, 72038, 72322, 72053, 72063, 72077, 72118, 72121, 72177, 72188, 72192, 72202, 72203, 72265, 72274, 72288, 72289, 72308, 72313, 72048, 72001, 72058, 72230, 72234, 72102, 72201, 72003, 72040, 72114, 72010, 72049, 72055, 72136, 72148, 72266, 72319, 72222, 72034, 72198, 72220, 72226, 72119, 72168, 72303, 72309, 72312, 72318, 72025, 72066, 72193, 72325, 72327, 72331, 72174, 72082, 72249;  3. Model Numbers (REF): 781283 (Achieva 1.5T Conversion); UDI-DI: N/A; Serial Numbers: 39056, 8989, 10126, 39098, 39108, 39004, 39010, 39028, 39032, 39086, 39094, 39095, 39058, 39091, 39105, 39053, 39073, 39067, 39016, 39025;  4. Model Numbers (REF): 781346 (Achieva 1.5 Conversion);  UDI-DI: N/A; Serial Numbers: 18052, 8361, 8415, 10015, 75008, 5243, 8727, 10172, 10189, 10545, 18737, 75002, 75003, 75004, 75015, 8059, 8757, 8767, 8842, 8883, 8886, 8897, 8946, 8974, 8981, 8990, 10060, 18001, 18710, 75009, 75092, 75095, 75099, 75100, 8069, 8312, 8520, 10006, 10048, 18588, 75000, 75001, 75005, 75031, 75049, 75087, 8371, 8289, 8367, 8740, 10539, 75011, 8351, 8782, 8756, 75010, 75007, 8124, 8020;  5. Model Numbers (REF): 781178 (Achieva 1.5T Initial System); UDI-DI: N/A; Serial Numbers: 20095, 20056, 20230, 20258, 20085, 20094, 20113, 20050, 20072, 20088, 20096, 20252, 20281, 20297, 20307;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3232-2026%22", "url": "https://recallledger.net/recalls/device-z-3232-2026-achieva-1-5t-achieva-1-5t-conversion-and-achieva-1-5t-initial-system/"}, {"id": "fda-device-z-3230-2026", "source": "FDA", "category": "device", "recall_number": "Z-3230-2026", "title": "Medline convenience kits containing Healthmark Instrument Channel Brushes.   SINUS... recall (Medline Industries, LP)", "product": "Medline convenience kits containing Healthmark Instrument Channel Brushes.   SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.", "reason": "Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MN and SD.", "states": ["MN", "SD"], "nationwide": true, "quantity": "90 kits (US)", "codes": "DYNJ48258F    UDI-DI 10198459038334    Lots 24HBR684   25CBS234   25GBH438   25JBC863   26FBU052", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3230-2026%22", "url": "https://recallledger.net/recalls/device-z-3230-2026-medline-convenience-kits-containing-healthmark-instrument-channel-brus/"}, {"id": "fda-device-z-3229-2026", "source": "FDA", "category": "device", "recall_number": "Z-3229-2026", "title": "Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK... recall (Medline Industries, LP)", "product": "Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.", "reason": "Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-10", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MN and SD.", "states": ["MN", "SD"], "nationwide": true, "quantity": "90 kits (US)", "codes": "DYNJ48258D    UDI-DI 10889942563272    Lots 23CBH459   23GBJ128   24ABM400", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3229-2026%22", "url": "https://recallledger.net/recalls/device-z-3229-2026-medline-convenience-kits-containing-healthmark-instrument-channel-brus/"}, {"id": "fda-device-z-3226-2026", "source": "FDA", "category": "device", "recall_number": "Z-3226-2026", "title": "SeaSpine  Mariner Deformity  Product Name: Extended Polyaxial Head recall (SEASPINE ORTHOPEDICS CORPORATION)", "product": "SeaSpine  Mariner Deformity  Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm  REF: MD1-300010-12", "reason": "The proximal thread depth of the spinal device is out of design specification.", "hazard_level": "Class II", "company": "SEASPINE ORTHOPEDICS CORPORATION", "company_location": "Carlsbad, CA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.", "states": ["AL", "CA", "CO", "CT", "FL", "GA", "MA", "MI", "MN", "MO", "NC", "NV", "NY", "OK", "OR", "TN", "TX", "VA"], "nationwide": true, "quantity": "270 units", "codes": "UDI-DI 10889981257248; Affected Lots: TE145060D, TE170356F, TE170556F, TE165793F, TE145059E, TE161254F, TE142282D.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3226-2026%22", "url": "https://recallledger.net/recalls/device-z-3226-2026-seaspine-mariner-deformity-product-name-extended-polyaxial-head-at/"}, {"id": "fda-device-z-3224-2026", "source": "FDA", "category": "device", "recall_number": "Z-3224-2026", "title": "PowerLED 300 Concealed Lighting System recall (Maquet SAS)", "product": "PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm)  Model Numbers: 1. ARD568474114A, 2. ARD567501286;", "reason": "The potential for the device to detach  at the junction between the spring arm and suspension arm and fall causing potential injury.", "hazard_level": "Class II", "company": "Maquet SAS", "company_location": "Orleans Cedex 2, France", "date": "2026-08-07", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "667", "codes": "1. Model Number: ARD568474114A;  UDI-DI: N/A; Serial Numbers: 500190, 500194, 500201, 500203, 500209, 500216, 500218, 500197, 500204, 500210, 500211, 500212, 500213, 500214, 500217, 500206, 500390, 500393, 500397, 500414, 500416, 500417, 500418, 500451, 500266, 500284, 500291, 500293, 500294, 500299, 500300, 500301, 500302, 500306, 500307, 500308, 500117, 500116, 500273, 500274, 500399, 500400, 500402, 500168, 500188, 500192, 500196, 500208, 500219, 500221, 500228, 500233, 500237, 500240, 500247, 500159, 500207, 500215, 500396, 500415, 500419, 500429, 500430, 500433, 500434, 500437, 500439, 500440, 500443, 500478, 500394, 500398, 500403, 500407, 500391, 500404, 500060, 500061, 500062, 500063, 500080, 500081, 500086, 500089, 500094, 500095, 500096, 500099, 500105, 500106, 500111, 500112, 500118, 500119, 500392, 500395, 500405, 500406, 500409, 500427, 500428, 500435, 500436, 500238, 500249, 500251, 500254, 500256, 500258, 500259, 500260, 500261, 500262, 500277, 500278, 500285, 500296, 500304, 500309, 500311, 500312, 500316, 500323, 500328, 500331, 500332, 500338, 500198, 500200, 500067, 500073, 500074, 500076, 500079, 500082, 500069, 500161, 500078, 500051, 500053, 500093, 500100, 500107, 500108, 500113, 500114, 500065, 500070, 500071, 500072, 500075, 500077, 500084, 500085, 500087, 500143, 500145, 500152, 500164, 500167, 500178, 500179, 500253, 500255, 500267, 500268, 500286, 500287, 500292, 500224, 500225, 500229, 500235, 500236, 500128, 500134, 500137, 500148, 500149, 500129, 500173, 500177, 500182, 500184, 500185, 500189, 500195, 500199, 500205, 500169, 500170, 500180, 500142, 500144, 500166, 500172, 500174, 500175, 500181, 500242, 500160, 500162, 500165, 500176, 500157, 500158, 500163, 500171, 500068, 500088, 500131, 500132, 500133, 500151, 500220, 500223, 500226, 500241, 500245, 500248, 500064, 500313, 500315, 500317, 500318, 500320, 500324, 500325, 500326, 500327, 500329, 500330, 500333, 500334, 500335, 500337, 500092, 500097, 500098, 500101, 500102, 500103, 500104, 500109, 500110, 500115, 500120, 500121, 500408, 500359, 500361, 500362, 500363, 500364, 500365, 500368, 500369, 500370, 500372, 500380, 500232, 500239, 500263, 500264, 500269, 500271, 500272, 500373, 500374, 500375, 500386, 500387, 500453, 500454, 500455, 500456, 500461, 500462, 500492, 500493, 500279, 500303, 500305, 500413, 500422, 500425, 500426, 500431, 500438, 500444, 500445, 500446, 500130, 500135, 500136, 500138, 500141, 500146, 500150, 500153, 500154, 500280, 500281, 500282, 500297, 500028, 500029, 500031, 500032, 500033, 500036, 500040, 500041, 500042, 500049, 500056, 500183, 500193, 500257, 500270, 500275, 500276, 500401, 500410, 500411, 500412, 500423, 500424, 500441, 500442, 500447, 500448, 500420, 500421, 500432, 500243, 500037, 500083, 500125, 500126, 500127, 500139, 500140, 500147, 500250, 500252, 500265, 500283, 500288, 500289, 500290, 500295, 500298, 500030, 500034, 500035, 500038, 500039, 500043, 500044, 500045, 500046, 500047, 500048, 500050, 500052, 500054, 500055, 500057, 500227, 500230, 500234, 500244, 500246, 500066, 500222, 500231, 500314, 500319, 500321, 500322, 500336, 500360, 500366, 500367, 500371, 500376, 500377, 500378, 500379, 500381, 500382, 500383, 500384, 500385, 500388, 500186;  2. Model Number: ARD567501286; UDI-DI: 03700712403478; Serial Numbers: 1314H000217400, 4014H000279430, 4014H000279432, 4014H000279433, 4014H000279434, 4014H000279437, 4014H000279438, 4314H000288228, 4314H000288229, 4314H000288232, 4314H000288233, 4314H000288234, 4314H000288237, 4314H000288239, 4314H000288257, 4314H000288258, 4314H000288259, 4714H000296081, 4717H000296095, 1315H000382641, 1715H000392775, 2115H000409030, 2115H000409038, 2115H000409040, 2115H000409062, 2113H000123425, 3613H000150570, 2115H000409063, 3015H000436557, 3015H000436569, 3015H000436571, 2115H000409065, 2115H000409067, 2615H000423256, 3015H000436561, 3015H000436566, 3015H000436570, 1314H000215902, 1314H000215904, 0116H000537022, 0716H000208366, 2816H000647716, 0615H000334882, 0615H000334887, 0615H000334891, 0815H000351763, 0815H000351768, 0815H000351780, 1314H000215893, 1314H000215894, 1314H000215896, 1314H000215900, 1314H000215903, 1314H000215907, 1314H000215885, 2114H000236788, 2613H000132823, 2613H000132825, 2613H000132826, 2613H000132827, 2613H000132828, 2614H000244892, 3613H000150571, 3613H000150572, 4014H000279429, 4014H000279431, 4314H000288230, 4314H000288235, 1314H000215886, 1314H000215895, 1314H000215898, 1314H000215899, 1314H000215908, 2114H000236778, 2114H000236779, 2114H000236787, 2114H000236789, 2114H000236790, 2614H000244886, 2115H000409051, 2115H000409058, 3015H000436556, 3015H000436558, 3015H000436568, 4314H000288231, 1314H000215888, 1314H000215889, 1314H000215906, 1314H000215879, 1314H000215880, 1314H000215881, 1314H000215882, 1314H000215890, 1314H000215892, 1314H000215897, 1314H000215901, 2614H000244885, 2113H000123420, 2113H000123421, 2113H000123423, 2113H000123424, 2113H000123426, 2113H000123427, 2113H000123429, 2613H000132824, 2816H000647710, 2614H000244884, 2614H000244889, 2114H000236777, 2114H000236782, 2114H000236785, 2614H000244877, 2614H000244878, 2614H000244883, 2614H000244890, 1314H000215905, 2115H000409039, 0116H000537017, 0116H000537020, 0116H000537021, 0116H000537023, 0116H000537024, 0116H000537025, 0116H000537026, 0615H000334878, 0615H000334881, 0715H000391839, 0716H000261478, 0716H000561475, 0716H000561479, 0716H000561493, 1314H000217399, 2215H000537018, 2615H000423253, 2816H000647709, 2816H000647712, 2816H000647714, 2916H000647713, 3015H000436560, 3015H000436564, 4314H000288260, 4714H000296097, 1314H000215883, 1314H000215884, 1314H000215887, 0815H000351782, 2115H000409029, 2114H000236780, 2114H000236781, 2114H000236783, 2114H000236784, 2114H000236786, 2614H000244879, 2614H000244880, 2614H000244887, 2614H000244888, 2614H000244891, 2115H000409027, 2115H000409055, 2115H000409032, 2115H000409034, 2115H000409053, 2115H000409064, 2115H000409070, 2615H000423252, 2615H000423254, 3015H000436563, 0116H000537019, 0716H000561481, 3613H000150569, 0615H000334888, 0615H000334889, 0716H000561477, 0716H000561480, 0615H000334883, 0615H000334884, 2115H000409068, 2115H000409069, 2615H000423258, 3015H000436559, 3015H000436562, 3015H000436565, 3015H000436567, 4314H000288236, 4314H000288240, 0615H000334885, 0615H000334886, 0615H000334890, 0815H000351765, 0815H000351767, 0815H000351771, 0815H000351776, 0815H000351777, 0815H000351779, 1314H000215891, 2614H000244881, 2614H000244882, 4014H000279436, 4314H000288238, 4314H000288261, 1813H000118088, 1813H000118093, 2613H000132815, 2613H000132818, 3613H000150533, 3613H000150534, 3613H000150537, 3613H000150538, 3613H000150541, 2613H000132811, 3613H000150544, 3613H000150545, 3613H000150546, 3613H000150547, 3613H000150548, 3613H000150565, 3613H000150566, 3613H000150567, 3613H000150568, 0815H000351774, 4014H000279428, 2115H000409054, 0815H000351773, 1315H000382643, 1315H000382644, 2115H000409028, 2115H000409033, 2115H000409035, 2115H000409036, 2115H000409037, 2115H000409052, 2115H000409056, 2115H000409057, 2115H000409059, 2115H000409060, 2115H000409061, 2816H000647715, 0815H000351775, 0815H000351778, 4014H000279435, 3613H000150535, 3613H000150536, 3613H000150539, 3613H000150540, 3613H000150542, 3613H000150543, 2115H000409031, 0815H000351764, 0815H000351766, 0815H000351769, 0815H000351770, 0815H000351772, 0815H000351781, 1813H000118090, 2113H0001231, 2113H000123428, 2613H000132800, 2613H000132801, 2613H000132802, 2613H000132803, 2613H000132804, 2613H000132806, 2613H000132807, 2613H000132808, 2613H000132809, 2613H000132810, 2613H000132812, 2613H000132813, 2613H000132814, 2813H000132805;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3224-2026%22", "url": "https://recallledger.net/recalls/device-z-3224-2026-powerled-300-concealed-lighting-system-pwd30-sf-w-k3-spring-arm-a2-fc/"}, {"id": "fda-device-z-3220-2026", "source": "FDA", "category": "device", "recall_number": "Z-3220-2026", "title": "Midmark IQvitals Zone recall (Midmark Corporation)", "product": "Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724", "reason": "A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.", "hazard_level": "Class II", "company": "Midmark Corporation", "company_location": "Versailles, OH, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "33 units", "codes": "Model No: 1-200-0360; UDI-DI: 00841709105838; Kit No: 4-000-0724; UDI-DI: 00841709105913;  Kit Serial Number: V2788703 V2788046 V2788016 V2788712 V2789302 V2789846 V2789830 V2789837 V2789808 V2789303 V2789304 V2811103 V2811112 V2862288 V2862275 V2869139 V2866577 V2867451 V2869599 V2868801 V2869154 V2868545 V2866984 V2869980 V2869969 V2868130 V2867433 V2868182 V2924525 V2924566 V2924559 V2924539 V2927525; Zone Serial Number: V2788322 V2787552 V2787555 V2788321 V2788905 V2789498 V2787554 V2789488 V2789499 V2788922 V2787553 V2807891 V2807893 V2837260 V2859050 V2868888 V2862992 V2866942 V2868893 V2868239 V2868840 V2868222 V2866940 V2868892 V2869397 V2867491 V2866963 V2868051 V2923639 V2922999 V2922998 V2923640 V2927201", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3220-2026%22", "url": "https://recallledger.net/recalls/device-z-3220-2026-midmark-iqvitals-zone-automatically-and-noninvasively-measures-systol/"}, {"id": "fda-device-z-3219-2026", "source": "FDA", "category": "device", "recall_number": "Z-3219-2026", "title": "Midmark IQvitals Zone recall (Midmark Corporation)", "product": "Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722", "reason": "A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.", "hazard_level": "Class II", "company": "Midmark Corporation", "company_location": "Versailles, OH, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "20 units", "codes": "Model No: 1-200-0350; UDI-DI: 00841709105821; Kit No: 4-000-0722; UDI-DI: 00841709105906;  Kit Serial Number: V2866143 V2866111 V2866124 V2864892 V2864113 V2864444 V2864120 V2864449 V2864894 V2866626 V2866636 V2871280 V2870561 V2869170 V2870570 V2869930 V2874364 V2897744 V2900961 V2900947; Zone Serial Number: V2864929 V2865546 V2864921 V2864495 V2796056 V2864174 V2858651 V2864142 V2873819 V2866216 V2866187 V2870249 V2870090 V2867500 V2866707 V2869394 V2873111 V2886635 V2873150 V2886126", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3219-2026%22", "url": "https://recallledger.net/recalls/device-z-3219-2026-midmark-iqvitals-zone-automatically-and-noninvasively-measures-systol/"}, {"id": "fda-device-z-3218-2026", "source": "FDA", "category": "device", "recall_number": "Z-3218-2026", "title": "Midmark IQvitals Zone recall (Midmark Corporation)", "product": "Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624", "reason": "A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.", "hazard_level": "Class II", "company": "Midmark Corporation", "company_location": "Versailles, OH, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "153 units", "codes": "Model No: 1-200-0330; UDI-DI: 00841709105807; Kit No: 4-000-0624; UDI-DI: 00841709105883;  Kit Serial Number: V2842901 V2841713 V2841724 V2842133 V2842105 V2841750 V2841701 V2842116 V2842081 V2842097 V2866067 V2871822 V2871211 V2871204 V2871817 V2881636 V2878754 V2878741 V2878759 V2879975 V2879979 V2879564 V2880715 V2880713 V2881270 V2880698 V2880711 V2879544 V2881253 V2882161 V2881704 V2882141 V2881259 V2881258 V2881698 V2881677 V2881684 V2879566 V2882146 V2879551 V2877649 V2877655 V2877673 V2880021 V2878308 V2878306 V2878734 V2877678 V2878299 V2878294 V2880023 V2875958 V2875328 V2877119 V2877065 V2874409 V2877114 V2874415 V2875941 V2875331 V2876441 V2876423 V2874794 V2874786 V2877057 V2877131 V2873684 V2876410 V2876449 V2873677 V2876455 V2888858 V2896346 V2897752 V2896689 V2897157 V2895863 V2899478 V2898923 V2896355 V2898561 V2896708 V2897134 V2896352 V2898573 V2895879 V2899469 V2895878 V2899455 V2898942 V2898200 V2896720 V2898188 V2898192 V2898563 V2898930 V2897759 V2897764 V2897128 V2914273 V2914285 V2914304 V2915752 V2918767 V2915294 V2917735 V2920483 V2919267 V2918780 V2918750 V2920462 V2920473 V2919288 V2919879 V2917216 V2915308 V2918123 V2914243 V2918146 V2916948 V2917204 V2914807 V2915283 V2915770 V2916220 V2915298 V2914786 V2920109 V2919859 V2919892 V2919298 V2919281 V2917241 V2917747 V2918173 V2917727 V2916228 V2916203 V2915760 V2914792 V2914817 V2915785 V2916239 V2916929 V2918139 V2917715 V2916785 V2914256 V2928158 V2928139 V2928117 V2928129 V2928148; Zone Serial Number: L1187570 V2839311 V2840480 V2841440 V2841442 V2839313 V2838889 V2841435 V2839314 V2841486 V2846602 V2845499 V2845501 V2866711 V2845500 V2881442 V2878467 V2878461 V2877997 V2879643 V2879586 V2878874 V2880188 V2880175 V2877380 V2880218 V2880199 V2878949 V2880749 V2881496 V2881388 V2881510 V2877999 V2878828 V2881403 V2881416 V2881439 V2878838 V2881509 V2878895 V2877353 V2877331 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"remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3218-2026%22", "url": "https://recallledger.net/recalls/device-z-3218-2026-midmark-iqvitals-zone-automatically-and-noninvasively-measures-systol/"}, {"id": "fda-device-z-3217-2026", "source": "FDA", "category": "device", "recall_number": "Z-3217-2026", "title": "Midmark IQvitals Zone recall (Midmark Corporation)", "product": "Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622", "reason": "A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.", "hazard_level": "Class II", "company": "Midmark Corporation", "company_location": "Versailles, OH, United States", "date": "2026-08-21", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1 units", "codes": "Model No: 1-200-0320; UDI-DI: 00841709105791; Kit No: 4-000-0622; UDI-DI: 00841709105876;  Kit Serial Number: V2900924; Zone Serial Number: V2899738", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3217-2026%22", "url": "https://recallledger.net/recalls/device-z-3217-2026-midmark-iqvitals-zone-automatically-and-noninvasively-measures-systol/"}, {"id": "fda-device-z-3216-2026", "source": "FDA", "category": "device", "recall_number": "Z-3216-2026", "title": "Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recall (Olympus Corporation of the Americas)", "product": "Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.", "reason": "Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-19", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "International distribution in the country of Japan.", "states": [], "nationwide": false, "quantity": "305 units", "codes": "Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3216-2026%22", "url": "https://recallledger.net/recalls/device-z-3216-2026-olympus-ezdilate-endoscopic-balloon-dilator-wired-guided-11-12-13mm/"}, {"id": "fda-device-z-3215-2026", "source": "FDA", "category": "device", "recall_number": "Z-3215-2026", "title": "Brand Name: Heidelberg Engineering GmbH  Product Name: SPECTRALIS with Flex Module ... recall (Heidelberg Engineering GmbH)", "product": "Brand Name: Heidelberg Engineering GmbH  Product Name: SPECTRALIS with Flex Module  Model/Catalog Number: S3610, S2610, S2000, S1610    multimodal imaging platform optimized for the posterior segment of the eye", "reason": "Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.", "hazard_level": "Class II", "company": "Heidelberg Engineering GmbH", "company_location": "Heidelberg, Germany", "date": "2026-08-06", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.", "states": ["MA"], "nationwide": true, "quantity": "87", "codes": "UDI-DI 04059237000235   Lot Code: Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, Spec-24611", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3215-2026%22", "url": "https://recallledger.net/recalls/device-z-3215-2026-brand-name-heidelberg-engineering-gmbh-product-name-spectralis-with/"}, {"id": "fda-device-z-3214-2026", "source": "FDA", "category": "device", "recall_number": "Z-3214-2026", "title": "Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5 recall (Boston Scientific Corporation)", "product": "Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5;    M001314011  IMAGER II/5/ST/100/038 BX5;    M001314021  IMAGER II/5/ST/65/035 BX 5;    M001314031  IMAGER II/5/ST/100/035 BX 5;    M001314041  IMAGER II/5/BARNH/100/038 BX5;    M001314051  IMAGER II/5/BERN/100/038 BX5;    M001314061  IMAGER II/5/BERN/100/035 BX 5;    M001314081  IMAGER II/5/BERN/40/038 BX5;    M001314101  IMAGER II/5/BERN/65/038 BX5;    M001314141  IMAGER II/5/H1/100/038 BX5;    M001314151  IMAGER II/5/H1/100/035 BX 5;    M001314301  IMAGER II/5/SIM1/65/038 BX5;    M001314321  IMAGER II/5/SIM1/100/038 BX5;    M001314341  IMAGER II/5/SIM2/100/038 BX5;    M001314351  IMAGER II/5/SIM2/100/035 BX 5;    M001314361  IMAGER II/5/SIM3/100/038 BX5;    M001314521  IMAGER II/5/CHGB/65/038 BX5;    M001314581  IMAGER II/5/CONTRA 2/65/038 BX5;    M001314621  IMAGER II/5/C1/65/038 BX5;    M001314661  00AGER II/5/C2/65/038 BX5;    M001314671  IMAGER II/5/C2/65/035 BX 5;    M001314761  IMAGER II/5/MIK/65/038 BX5;    M001314771  IMAGER II/5/MIK/65/035 BX 5;    M001314821  IMAGER II/5/SHK1.0/65/038 BX5;    M001314861  IMAGER II/5/RC2/65/038 BX5;    M001314881  IMAGER II/5/RDC/65/038 BX5", "reason": "Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. 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Bank Gaza Strip, Yemen.", "states": ["GA", "PR"], "nationwide": true, "quantity": "262,686", "codes": "M001314001    UDI-DI 08714729354826    Batches 74B2500089   74C2600048   74E2500888   74G2500942   74H2500390   74K2400624   74K2500754   74L2400920  M001314011    UDI-DI 08714729354833    Batches 74B2500937   74F2500509   74L2400427   74L2400913   74L2500679   74M2400314  M001314021    UDI-DI 08714729354840    Batches 74A2500370   74C2500582   74E2500889   74E2600070   74G2500421   74H2500875   74K2400982   74K2500755   74L2500841  M001314031    UDI-DI 08714729354857    Batches 74B2501237   74D2600727   74F2500968   74M2400317  M001314041    UDI-DI 08714729354864    Batches 74A2500996   74B2600070   74D2501155   74D2600456   74G2500951   74K2401116  M001314051    UDI-DI 08714729354871    Batches 74A2500586   74A2500997   74B2500090   74B2500711   74B2500940   74B2501238   74B2600079   74B2600310   74B2600390   74B2600412   74B2600573   74C2501047   74C2600348   74C2600430   74C2600531   74D2500124   74D2500424   74D2501156   74D2600455   74D2600857   74D2601116   74E2500982   74E2501194   74F2500511   74F2500599   74F2500768   74G2500422   74G2500759   74G2501153   74G2501349   74H2500392   74H2500659   74H2500665   74H2501042   74J2500318   74J2500552   74K2401330   74K2500164   74K2500756   74K2500917   74L2400720   74L2500033   74L2500680   74M2400072   74M2400304   74M2400318   74M2500245  M001314061    UDI-DI 08714729354888    Batches 74A2500044   74A2500587   74A2600261   74A2600415   74B2500091   74B2500488   74B2600080   74B2600895   74C2500053   74C2500583   74C2600350   74D2500125   74D2500426   74D2600575   74E2500201   74E2500293   74E2500981   74E2501195   74F2500969   74G2500778   74G2501350   74H2501041   74J2500085   74K2400625   74K2500759   74L2400041   74L2400411   74L2400418   74L2401248   74L2401259   74L2500681   74L2500831   74L2500939   74M2400303   74M2400305  M001314081    UDI-DI 08714729354901    Batches 74A2500375   74A2600681   74B2500489   74B2600042   74B2600328   74B2600329   74C2500584   74D2500427   74E2500294   74E2501196   74E2600412   74E2600413   74F2500722   74G2500910   74G2500943   74G2501351   74H2500234   74H2501035   74K2401069   74L2400419   74L2400687   74L2500359   74L2500682   74M2400306  M001314101    UDI-DI 08714729354925    Batches 74A2500376   74A2500461   74A2600324   74A2600417   74A2600680   74B2600572   74B2600590   74B2600840   74C2500021   74C2500046   74C2500585   74C2600043   74C2600044   74C2600532   74C2600810   74D2500604   74D2500682   74D2600039   74D2600050   74D2600578   74E2500295   74E2501197   74E2600071   74E2600193   74E2600194   74E2600870   74F2500120   74F2500767   74F2500970   74F2600059   74F2600328   74G2500476   74G2500944   74H2500383   74J2500170   74J2500547   74K2400361   74K2401070   74K2401317   74K2500165   74K2501039   74L2400939   74L2401250   74L2500367   74M2400075   74M2500092   74M2500571  M001314141    UDI-DI 08714729354963    Batches 74A2501084   74A2600685   74B2600078   74B2600575   74D2600457   74G2500945   74K2401113   74M2500705  M001314151    UDI-DI 08714729354970    Batches 74C2500767   74E2600505   74F2500121   74F2500967   74L2401249  M001314301    UDI-DI 08714729355120    Batches 74A2500462   74A2600059   74B2500490   74C2500768   74C2600046   74C2600733   74E2500296   74F2500971   74F2600062   74F2600329   74G2500190   74H2500223   74J2500080   74K2400362   74L2500032   74M2500572  M001314321    UDI-DI 08714729355144    Batches 74A2500588   74B2500491   74B2501240   74B2600539   74C2500769   74D2600571   74F2500122   74G2500191   74G2500947   74H2500235   74L2401251   74M2500706  M001314341    UDI-DI 08714729355168    Batches 74A2500589   74B2500492   74B2600591   74C2500770   74D2500683   74D2600572   74E2500297   74F2500123   74G2501345   74H2500236   74J2500083   74K2401321   74K2500758   74L2400689   74M2400065   74M2500084   74M2500576   74M2500708  M001314351    UDI-DI 08714729355175    Batches 74A2500590   74A2600416   74B2500708   74C2500771   74D2500684   74E2500298   74E2600507   74F2500124   74G2500192   74G2501346   74H2500237   74K2401322   74M2400066   74M2400783   74M2500242  M001314361    UDI-DI 08714729355182    Batches 74F2500125   74M2500709  M001314521    UDI-DI 08714729355342    Batches 74E2500646  M001314581    UDI-DI 08714729355403    Batches 74A2500463   74A2500988   74A2600331   74A2600683   74A2600684   74B2500709   74C2500772   74C2600045   74C2600702   74D2500685   74E2500647   74E2600072   74F2500126   74F2600060   74G2500193   74H2500384   74J2500305   74K2400615   74K2400616   74K2401117   74K2501040   74L2400424   74L2400721   74L2400938   74L2401290   74L2500029   74M2400734   74M2500093  M001314621    UDI-DI 08714729355441    Batches 74A2500990   74A2501085   74A2501087   74D2500686   74E2500301   74E2500648   74F2500127   74H2500225   74J2500306   74K2400617   74K2501041   74L2400722   74L2400915   74L2401253   74L2500370   74M2400078  M001314661    UDI-DI 08714729355489    Batches 74A2500993   74A2501311   74A2600061   74A2600682   74B2500493   74B2500710   74C2500047   74C2500773   74C2600533   74D2500687   74D2500881   74D2600579   74E2500649   74F2500128   74F2500503   74G2500194   74H2500226   74H2500385   74J2500086   74J2500307   74K2400618   74K2500166   74K2501042   74L2400916   74L2401254   74L2500021   74L2500371   74L2500683   74M2400067   74M2400079   74M2500573  M001314671    UDI-DI 08714729355496    Batches 74A2500111   74A2501312   74A2600058   74C2500048   74C2501039   74C2600530   74D2500882   74D2600577   74E2500650   74F2500504   74G2500195   74H2500386   74J2500308   74K2400619   74K2401114   74K2501165   74M2400068   74M2500574  M001314761    UDI-DI 08714729355588    Batches 74A2501313   74C2500774   74E2500651   74E2500882   74F2600061   74G2500224   74K2500753  M001314771    UDI-DI 08714729355595    Batches 74A2501314   74C2500049   74C2600703   74D2500038   74D2500883   74E2500883   74E2600508   74E2600869   74F2500505   74F2600058   74G2500333   74H2500873   74J2500316   74J2500549   74L2400426   74L2500689   74M2400069  M001314821    UDI-DI 08714729355649    Batches 74A2600702   74B2500082   74B2600311   74C2500050   74C2501041   74F2500506   74K2500163   74L2400937  M001314861    UDI-DI 08714729355687    Batches 74C2500051   74L2400936   74M2500086  M001314881    UDI-DI 08714729355700    Batches 74E2500884   74G2500226   74G2500334   74J2500311   74K2400620   74L2500022", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3214-2026%22", "url": "https://recallledger.net/recalls/device-z-3214-2026-imager-ii-angiographic-catheters-m001314001-imager-ii-5-st-65-038/"}, {"id": "fda-device-z-3140-2026", "source": "FDA", "category": "device", "recall_number": "Z-3140-2026", "title": "INCA recall (CooperSurgical, Inc.)", "product": "INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.", "reason": "Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.", "hazard_level": "Class I", "company": "CooperSurgical, Inc.", "company_location": "Trumbull, CT, United States", "date": "2026-08-11", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.", "states": ["CT", "FL", "GA", "IA", "IL", "IN", "MD", "MI", "MS", "NJ", "NY", "OH", "PA", "VA"], "nationwide": true, "quantity": "149 boxes (745 units)", "codes": "1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624.   2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057.   3.  Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623.   4.  Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3140-2026%22", "url": "https://recallledger.net/recalls/device-z-3140-2026-inca-infant-nasal-cannulae-assy-neonatal-nasal-cpap-replacement-set/"}, {"id": "fda-device-z-3139-2026", "source": "FDA", "category": "device", "recall_number": "Z-3139-2026", "title": "INCA recall (CooperSurgical, Inc.)", "product": "INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.", "reason": "Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.", "hazard_level": "Class I", "company": "CooperSurgical, Inc.", "company_location": "Trumbull, CT, United States", "date": "2026-08-11", "report_date": "2026-09-30", "status": "Ongoing", "distribution": "Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.", "states": ["CT", "FL", "GA", "IA", "IL", "IN", "MD", "MI", "MS", "NJ", "NY", "OH", "PA", "VA"], "nationwide": true, "quantity": "2,643 boxes (13,215 units)", "codes": "1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722.   2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621.   3.  Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760.   4.  Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619.   5.  Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3139-2026%22", "url": "https://recallledger.net/recalls/device-z-3139-2026-inca-infant-nasal-cannulae-assy-infant-nasal-cpap-complete-set-sta/"}, {"id": "fda-food-h-1388-2026", "source": "FDA", "category": "food", "recall_number": "H-1388-2026", "title": "Mon Sire Brie recall (Optimus Inc. d/b/a/ Markys Caviar)", "product": "Mon Sire Brie, soft-ripened French cheese, 1 kg, packed in carboard carton and wrapped in plastic parchment paper, 2 units each, Keep Refrigerated", "reason": "The firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes.", "hazard_level": "Class I", "company": "Optimus Inc. d/b/a/ Markys Caviar", "company_location": "Miami Gardens, FL, United States", "date": "2026-08-25", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Florida", "states": ["FL"], "nationwide": false, "quantity": "22 cases (44 units)", "codes": "LOT 00000ZRAA1  EXP 08/15/2026 LOT 00000ZUAD2  EXP 08/18/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1388-2026%22", "url": "https://recallledger.net/recalls/food-h-1388-2026-mon-sire-brie-soft-ripened-french-cheese-1-kg-packed-in-carboard-ca/"}, {"id": "fda-food-h-1387-2026", "source": "FDA", "category": "food", "recall_number": "H-1387-2026", "title": "Hexing Haw Balls candy recall (Tiffany Food Corp)", "product": "Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to eat. Storage: keep in cool and dry place and keep tightly closed in refrigerator after opening.; PRODUCT OF CHINA; UPC 6 920603 810025", "reason": "Unapproved dye Ponceau 4R", "hazard_level": "Class III", "company": "Tiffany Food Corp", "company_location": "Brooklyn, NY, United States", "date": "2026-08-28", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "AZ, NY, CA, FL, GA, IL, MA, MN, NC, NJ, OH, PA, NY, TN, TX, VA", "states": ["AZ", "CA", "FL", "GA", "IL", "MA", "MN", "NC", "NJ", "NY", "OH", "PA", "TN", "TX", "VA"], "nationwide": false, "quantity": "38 cartons", "codes": "Best Before 10/01/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1387-2026%22", "url": "https://recallledger.net/recalls/food-h-1387-2026-hexing-haw-balls-candy-packaged-in-200g-0-44-lb-7-05-oz-clear-plasti/"}, {"id": "fda-food-h-1386-2026", "source": "FDA", "category": "food", "recall_number": "H-1386-2026", "title": "PUMPKIN SPICE NO BAKE COOKIE recall (Best Friends Bakery, LLC)", "product": "PUMPKIN SPICE NO BAKE COOKIE NET WT 3.5 oz. INGREDIENTS: WHOLE GRAIN OATS, MILK, MARGARINE***WATER, SALT, CONTAINS LESS THAN 2% OF THE FOLLOWING: SOY LECITHIN, VEGETABLE MONO & DIGLYCERIDES, POTASSIUM SORBATE***, CITRIC ACID, NATURAL & ARTIFICIAL FLAVOR, BETA CAROTENE, VITAMIN A PALMITATE ADDED, PEANUT BUTTER***VANILLA***PUMPKIN PIE SPICE***GLYCERINE, PAPRIKA OLEORESINM, POTASSIUM SORBATE CONTAINS: EGG, MILK, SOY, WHEAT MADE IN A FACILITY WITH PEANUTS AND TREE NUTS UPC 8 10158 14087 5 Michelle's Bakery 101 Fashion Ave Connelly Springs, NC 28612", "reason": "Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but there are no eggs in the product.", "hazard_level": "Class II", "company": "Best Friends Bakery, LLC", "company_location": "Connelly Springs, NC, United States", "date": "2026-08-17", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Product was shipped to the following states: AL, FL, GA, IN, KY, MI, OH, TN, VA &  WV.", "states": ["AL", "FL", "GA", "IN", "KY", "MI", "OH", "TN", "VA", "WV"], "nationwide": false, "quantity": "1,416/3.5oz cookies", "codes": "Lot 20326", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1386-2026%22", "url": "https://recallledger.net/recalls/food-h-1386-2026-pumpkin-spice-no-bake-cookie-net-wt-3-5-oz-ingredients-whole-grain-o/"}, {"id": "fda-food-h-1380-2026", "source": "FDA", "category": "food", "recall_number": "H-1380-2026", "title": "Organic Triple Berry Blend Strawberries recall (Frutas y Hortalizas del Sur S.A.)", "product": "Organic Triple Berry Blend Strawberries, Blackberries & Blueberries, NET WT 10 OZ (283g), packed in plastic bag, 5 bags per case of 10 OZ each. KEEP FROZEN", "reason": "Potential E. coli O145:H28 Contamination", "hazard_level": "Class I", "company": "Frutas y Hortalizas del Sur S.A.", "company_location": "San Carlos, N/A, Chile", "date": "2026-08-28", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "AR", "states": ["AR"], "nationwide": false, "quantity": "3,026 cases", "codes": "Lot 6 040 01-6 Best by Date Feb 09 2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1380-2026%22", "url": "https://recallledger.net/recalls/food-h-1380-2026-organic-triple-berry-blend-strawberries-blackberries-blueberries-n/"}, {"id": "fda-food-h-1379-2026", "source": "FDA", "category": "food", "recall_number": "H-1379-2026", "title": "PICO DE GALLO-HOT-6/9oz HEB-PICO-HOT-12/14oz recall (NatureBest Pre-Cut & Produce LLc)", "product": "PICO DE GALLO-HOT-6/9oz HEB-PICO-HOT-12/14oz", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184 - 190A26216", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1379-2026%22", "url": "https://recallledger.net/recalls/food-h-1379-2026-pico-de-gallo-hot-6-9oz-heb-pico-hot-12-14oz/"}, {"id": "fda-food-h-1378-2026", "source": "FDA", "category": "food", "recall_number": "H-1378-2026", "title": "HEB-PICO-MEDIUM-12/14oz PICO DE GALLO-MEDIUM-6/14oz PICO DE GALLO-MEDIUM-6/9oz... recall (NatureBest Pre-Cut & Produce LLc)", "product": "HEB-PICO-MEDIUM-12/14oz PICO DE GALLO-MEDIUM-6/14oz PICO DE GALLO-MEDIUM-6/9oz PICO-DE-GALLO-MEDIUM-BGC-1/5# PICO-MEDIUM-SNACK-12/4oz", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "400B26184, 400B26187, 400B26188, 400B26189, 400B26190, 400B26191, 400B26194, 400B26195, 400B26196, 400B26197, 400B26198, 400B26201, 400B26202, 400B26203, 400B26204, 400B26205, 400B26208, 400B26209, 400B26210, 400B26211, 400B26212", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1378-2026%22", "url": "https://recallledger.net/recalls/food-h-1378-2026-heb-pico-medium-12-14oz-pico-de-gallo-medium-6-14oz-pico-de-gallo-medi/"}, {"id": "fda-food-h-1377-2026", "source": "FDA", "category": "food", "recall_number": "H-1377-2026", "title": "HEB-GUAC KIT-MILD-3/57.5oz recall (NatureBest Pre-Cut & Produce LLc)", "product": "HEB-GUAC KIT-MILD-3/57.5oz", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "400B26184, 400B26187, 400B26188, 400B26189, 400B26190, 400B26191, 400B26194, 400B26195, 400B26196, 400B26197, 400B26198, 400B26201, 400B26202, 400B26203, 400B26204, 400B26205, 400B26208, 400B26209, 400B26210, 400B26211, 400B26212", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1377-2026%22", "url": "https://recallledger.net/recalls/food-h-1377-2026-heb-guac-kit-mild-3-57-5oz/"}, {"id": "fda-food-h-1376-2026", "source": "FDA", "category": "food", "recall_number": "H-1376-2026", "title": "NatureBest Mild Cheddar & Jalapeno Stuffed Mushrooms 8oz recall (NatureBest Pre-Cut & Produce LLc)", "product": "NatureBest Mild Cheddar & Jalapeno Stuffed Mushrooms 8oz (227g) HEB SI JAL POP STFFD MUSHRM-6/8oz", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184 - 190A26216", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1376-2026%22", "url": "https://recallledger.net/recalls/food-h-1376-2026-naturebest-mild-cheddar-jalapeno-stuffed-mushrooms-8oz-227g-heb-si/"}, {"id": "fda-food-h-1375-2026", "source": "FDA", "category": "food", "recall_number": "H-1375-2026", "title": "PEPPER-JALAPENO-DC 1/4\"-4/5# PEPPER-JALAPENO-DC 1/4\"-1/5# PEPPER-JALAPENO-SL 1/8\"-1/5#... recall (NatureBest Pre-Cut & Produce LLc)", "product": "PEPPER-JALAPENO-DC 1/4\"-4/5# PEPPER-JALAPENO-DC 1/4\"-1/5# PEPPER-JALAPENO-SL 1/8\"-1/5# PEPPER-JAL/SER-MINCE W/SD-6/5# PEPPER-JALAPENO-DC 3/8\"-4/5# PEPPER-JALAPENO-DC 1/8\"-BG-10# Pepper Jalapeno Destem PEPPER-JALAPENO-WHOLE-1# JALAPENO-DICED-6/3oz HEB-JALAPENO-DICED-8/3oz-SS", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184, 190A26187, 190A26188, 190A26189, 190A26190, 190A26192, 190A26195, 190A26196, 190A26197, 190A26198, 190A26199, 190A26201, 190A26202, 400B26194, 400B26208; 190A26212; 25AG4B, 48315A, ABF399, C5E27F; 190A26184 - 190A26216; 190A26184, 190A26187, 190A26189, 190A26191, 190A26194, 190A26196, 190A26198, 190A26201, 190A26203, 190A26205, 190A26208, 190A26210, 190A26212, 190A26213,  190A26215", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1375-2026%22", "url": "https://recallledger.net/recalls/food-h-1375-2026-pepper-jalapeno-dc-1-4-4-5-pepper-jalapeno-dc-1-4-1-5-pepper-jalap/"}, {"id": "fda-food-h-1374-2026", "source": "FDA", "category": "food", "recall_number": "H-1374-2026", "title": "HEB-PICO-MANGO-12/14oz PICO DE GALLO-MANGO-4/14oz PICO DE GALLO-MANGO-6/14oz recall (NatureBest Pre-Cut & Produce LLc)", "product": "HEB-PICO-MANGO-12/14oz PICO DE GALLO-MANGO-4/14oz PICO DE GALLO-MANGO-6/14oz", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184 - 190A26216", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1374-2026%22", "url": "https://recallledger.net/recalls/food-h-1374-2026-heb-pico-mango-12-14oz-pico-de-gallo-mango-4-14oz-pico-de-gallo-mango/"}, {"id": "fda-food-h-1373-2026", "source": "FDA", "category": "food", "recall_number": "H-1373-2026", "title": "SOUP MIX-6/58oz Tray recall (NatureBest Pre-Cut & Produce LLc)", "product": "SOUP MIX-6/58oz Tray, PPS971 CLR PET 900/cs 32cs/pal, film-sealed (18\" 16 Micron Perserva Wrap 5000/rl), packed in 30# Kale 44ect", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184, 190A26187, 190A26189, 190A26192, 190A26194, 190A26196, 190A26199, 190A26201, 190A26203, 190A26206, 190A26208, 190A26210, 190A26213", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1373-2026%22", "url": "https://recallledger.net/recalls/food-h-1373-2026-soup-mix-6-58oz-tray-pps971-clr-pet-900-cs-32cs-pal-film-sealed-18/"}, {"id": "fda-food-h-1372-2026", "source": "FDA", "category": "food", "recall_number": "H-1372-2026", "title": "PICO DE GALLO-MILD-4oz PICO DE GALLO-MILD-6/14oz PICO DE GALLO-4/5# PICO DE GALLO-1/5#... recall (NatureBest Pre-Cut & Produce LLc)", "product": "PICO DE GALLO-MILD-4oz PICO DE GALLO-MILD-6/14oz PICO DE GALLO-4/5# PICO DE GALLO-1/5# PICO DE GALLO-MILD-1/5#", "reason": "Jalapenos have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "NatureBest Pre-Cut & Produce LLc", "company_location": "Missouri City, TX, United States", "date": "2026-08-05", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Texas and Louisiana", "states": ["LA", "TX"], "nationwide": false, "quantity": "62,856 cases (total)", "codes": "190A26184 - 190A26216", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1372-2026%22", "url": "https://recallledger.net/recalls/food-h-1372-2026-pico-de-gallo-mild-4oz-pico-de-gallo-mild-6-14oz-pico-de-gallo-4-5-pi/"}, {"id": "fda-food-h-1368-2026", "source": "FDA", "category": "food", "recall_number": "H-1368-2026", "title": "BH Bold Chef Salad Kit. Ingredients: Iceberg Lettuce recall (Taylor Fresh Foods Inc)", "product": "BH Bold Chef Salad Kit. Ingredients: Iceberg Lettuce, Pico De Gallo (***Jalapeno Pepper), Jalapeno Ranch Dressing (***Jalapeno Peppers***), Egg, Cucumber, Black Olives *** Carrot, Red Cabbage.", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Florida: 2,560 units", "codes": "Florida: TFFL209, 8/9/2026; TFFL210, 8/10/2026; TFFL211, 8/11/2026; TFFL212, 8/12/2026; TFFL213, 8/13/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1368-2026%22", "url": "https://recallledger.net/recalls/food-h-1368-2026-bh-bold-chef-salad-kit-ingredients-iceberg-lettuce-pico-de-gallo/"}, {"id": "fda-food-h-1367-2026", "source": "FDA", "category": "food", "recall_number": "H-1367-2026", "title": "Pico De Gallo. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo. Ingredients: Tomato, Red Onion, Green Bell Pepper, Tomato Juice (Tomato Juice from Concentrate [Water, Concentrated Juices from Tomatoes], Salt, Vitamin C [Ascorbic Acid]), Lime Juice, Garlic, Salt, Cilantro. Net Wt: 12 oz. Keep Refrigerated.  Distributed By: WAWA Inc., Wawa, PA 19063.", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Kentucky: 285 units", "codes": "Kentucky: TFKY216A, 8/9/2026; TFKY217A, 8/10/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1367-2026%22", "url": "https://recallledger.net/recalls/food-h-1367-2026-pico-de-gallo-ingredients-tomato-red-onion-green-bell-pepper-toma/"}, {"id": "fda-food-h-1366-2026", "source": "FDA", "category": "food", "recall_number": "H-1366-2026", "title": "Fresh Pico Tray. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Fresh Pico Tray. Ingredients: Tomato, Yellow Onion, Jalapeno Pepper, Cilantro. Net Wt: 5 lbs.", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 73 units", "codes": "Tennessee: TFTN2162, 8/18/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1366-2026%22", "url": "https://recallledger.net/recalls/food-h-1366-2026-fresh-pico-tray-ingredients-tomato-yellow-onion-jalapeno-pepper-c/"}, {"id": "fda-food-h-1365-2026", "source": "FDA", "category": "food", "recall_number": "H-1365-2026", "title": "Pico De Gallo Hot. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo Hot. Ingredients: Tomato, Red Onion, Jalapeno Pepper, Lemon Juice, Cilantro, Salt. Net Wt: 2.5 lbs.", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 222 units", "codes": "Tennessee: TFTN2162, 8/18/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1365-2026%22", "url": "https://recallledger.net/recalls/food-h-1365-2026-pico-de-gallo-hot-ingredients-tomato-red-onion-jalapeno-pepper-le/"}, {"id": "fda-food-h-1364-2026", "source": "FDA", "category": "food", "recall_number": "H-1364-2026", "title": "Tomato Salsa Fresca. Ingredients: Tomatoes recall (Taylor Fresh Foods Inc)", "product": "Tomato Salsa Fresca. Ingredients: Tomatoes, Yellow Onion, Red Onion, Cilantro, Jalapeno Pepper, Garlic, Salt, Ground Cumin, Lemon Juice. Net Wt: 4 lbs. Keep Refrigerated.", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 256 units", "codes": "Tennessee: TFTN2162, 8/19/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1364-2026%22", "url": "https://recallledger.net/recalls/food-h-1364-2026-tomato-salsa-fresca-ingredients-tomatoes-yellow-onion-red-onion-c/"}, {"id": "fda-food-h-1363-2026", "source": "FDA", "category": "food", "recall_number": "H-1363-2026", "title": "Salsa Fresca Medium. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Salsa Fresca Medium. Ingredients: Tomato, Yellow Onion, Jalapeno Pepper, Pasteurized Lemon Juice, Garlic, Salt, Cilantro, Ground Cumin. Net Wt: 12 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075080", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 3,360 units; Texas: 2,040 units", "codes": "Illinois: TFIC207, 8/7/2026; TFIC209, 8/9/2026; TFIC211, 8/11/2026. Texas: TFTX209U11, 8/9/2026; TFTX211, 8/11/2026; TFTX213U11, 8/13/2026; TFTX216, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1363-2026%22", "url": "https://recallledger.net/recalls/food-h-1363-2026-salsa-fresca-medium-ingredients-tomato-yellow-onion-jalapeno-peppe/"}, {"id": "fda-food-h-1362-2026", "source": "FDA", "category": "food", "recall_number": "H-1362-2026", "title": "Salsa Verde Mild. Ingredients: Whole Tomatillos recall (Taylor Fresh Foods Inc)", "product": "Salsa Verde Mild. Ingredients: Whole Tomatillos (***), Roasted Poblano Chile, Jalapeno Pepper, Cilantro, Serrano Pepper, Garlic, Salt. Net Wt: 12 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075639", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 1,680 units; Texas: 1,440 units", "codes": "Illinois: TFIC207, 8/7/2026; TFIC209, 8/9/2026; TFIC211, 8/11/2026. Texas: TFTX209U11, 8/9/2026; TFTX211, 8/11/2026; TFTX213U11, 8/13/2026; TFTX216, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1362-2026%22", "url": "https://recallledger.net/recalls/food-h-1362-2026-salsa-verde-mild-ingredients-whole-tomatillos-roasted-poblano/"}, {"id": "fda-food-h-1361-2026", "source": "FDA", "category": "food", "recall_number": "H-1361-2026", "title": "Salsa Roja Medium. Ingredients: Fire Roasted Diced Tomatoes in Juice recall (Taylor Fresh Foods Inc)", "product": "Salsa Roja Medium. Ingredients: Fire Roasted Diced Tomatoes in Juice (***), Yellow Onion, Jalapeno Peppers, Arbol Chile Water Mix (***), Cilantro, Garlic, Salt, Ground Cumin. Net Wt: 12 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075646", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 2,760 units; Texas: 2,040 units", "codes": "Illinois: TFIC207, 8/7/2026; TFIC209, 8/9/2026; TFIC211, 8/11/2026. Texas: TFTX209, 8/9/2026; TFTX211, 8/11/2026; TFTX213U11, 8/13/2026; TFTX216, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1361-2026%22", "url": "https://recallledger.net/recalls/food-h-1361-2026-salsa-roja-medium-ingredients-fire-roasted-diced-tomatoes-in-juice/"}, {"id": "fda-food-h-1360-2026", "source": "FDA", "category": "food", "recall_number": "H-1360-2026", "title": "Pico De Gallo Spicy. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo Spicy. Ingredients: Tomato, Yellow Onion, Serrano Pepper, Jalapeno Pepper, Cilantro, Pasteurized Lime Juice, Salt. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075608", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 3,720 units; Texas: 3,120 units", "codes": "Illinois: TFIC207, 8/7/2026; TFIC209, 8/9/2026; TFIC211, 8/11/2026. Texas: TFTX209, 8/9/2026; TFTX211016, 8/11/2026; TFTX213008, 8/13/2026; TFTX216016, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1360-2026%22", "url": "https://recallledger.net/recalls/food-h-1360-2026-pico-de-gallo-spicy-ingredients-tomato-yellow-onion-serrano-pepper/"}, {"id": "fda-food-h-1359-2026", "source": "FDA", "category": "food", "recall_number": "H-1359-2026", "title": "Pico De Gallo Mild. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo Mild. Ingredients: Tomato, Yellow Onion, Jalapeno Pepper, Cilantro, Pasteurized Lime Juice, Salt. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075097", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 5,760 units; Texas: 3,720 units", "codes": "Illinois: TFIC207, 8/7/2026; TFIC209, 8/9/2026; TFIC211, 8/11/2026. Texas: TFTX209, 8/9/2026; TFTX211016, 8/11/2026; TFTX213008, 8/13/2026; TFTX216016, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1359-2026%22", "url": "https://recallledger.net/recalls/food-h-1359-2026-pico-de-gallo-mild-ingredients-tomato-yellow-onion-jalapeno-pepper/"}, {"id": "fda-food-h-1358-2026", "source": "FDA", "category": "food", "recall_number": "H-1358-2026", "title": "Hot Pico De Gallo. Ingredients: Tomatoes recall (Taylor Fresh Foods Inc)", "product": "Hot Pico De Gallo. Ingredients: Tomatoes, Red Onions, Jalapeno Peppers, Lime Juice Concentrate, Serrano Peppers, Cilantro, Garlic, Salt. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Walmart Inc., Bentonville, AR 72716.  UPC: 681131276351", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Florida: 1,344 units; Kentucky 2,128 units; Texas: 7,168 units", "codes": "Florida: TFFL208, 8/9/2026; TFFL210, 8/10/2026; TFFL212, 8/13/2026. Kentucky: TFKY215B, 8/16/2026; TFKY217B, 8/18/2026. Texas: TFTX208016, 8/8/2026; TFTX209016, 8/9/2026; TFTX210016, 8/10/2026; TFTX212016, 8/12/2026; TFTX215016, 8/15/2026; TFTX216016, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1358-2026%22", "url": "https://recallledger.net/recalls/food-h-1358-2026-hot-pico-de-gallo-ingredients-tomatoes-red-onions-jalapeno-peppers/"}, {"id": "fda-food-h-1357-2026", "source": "FDA", "category": "food", "recall_number": "H-1357-2026", "title": "Mild Pico De Gallo. Ingredients: Tomatoes recall (Taylor Fresh Foods Inc)", "product": "Mild Pico De Gallo. Ingredients: Tomatoes, Red Onions, Lime Juice Concentrate, Jalapeno Peppers, Garlic, Cilantro, Salt. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Walmart Inc., Bentonville, AR 72716.  UPC: 681131276344", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Florida: 3,920 units; Kentucky: 5,264 units; Texas: 19,920 units", "codes": "Florida: TFFL208, 8/9/2026; TFFL210, 8/10/2026; TFFL212, 8/13/2026. Kentucky: TFKY216B, 8/17/2026. Texas: TFTX208016, 8/8/2026; TFTX209016, 8/9/2026; TFTX210016, 8/10/2026; TFTX211016, 8/11/2026; TFTX212016, 8/12/2026; TFTX213, 8/13/2026; TFTX2013016, 8/13/2026; TFTX215016, 8/15/2026; TFTX216016, 8/16/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1357-2026%22", "url": "https://recallledger.net/recalls/food-h-1357-2026-mild-pico-de-gallo-ingredients-tomatoes-red-onions-lime-juice-conc/"}, {"id": "fda-food-h-1356-2026", "source": "FDA", "category": "food", "recall_number": "H-1356-2026", "title": "Pico De Gallo. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno, Cilantro. Net Wt: 16 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223073536", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Texas: 1,704 units", "codes": "Texas: TFTX208016, 8/7/2026; TFTX210016, 8/9/2026; TFTX212016, 8/11/2026; TFTX215016, 8/14/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1356-2026%22", "url": "https://recallledger.net/recalls/food-h-1356-2026-pico-de-gallo-ingredients-tomato-onion-jalapeno-cilantro-net-wt/"}, {"id": "fda-food-h-1355-2026", "source": "FDA", "category": "food", "recall_number": "H-1355-2026", "title": "Pico De Gallo. Ingredients: Tomato recall (Taylor Fresh Foods Inc)", "product": "Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno Pepper, Cilantro, Garlic, Salt, Black Pepper. Net Wt: 7 oz. Keep Refrigerated.  Distributed By: ADUSA Distribution, LLC, Salisbury, NC 28147.  UPC: 688267575778", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Rhode Island: 6,264 units", "codes": "Rhode Island: TFNE210A, 8/9/2026; TFNE212A, 8/11/2026; TFNE213A, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1355-2026%22", "url": "https://recallledger.net/recalls/food-h-1355-2026-pico-de-gallo-ingredients-tomato-onion-jalapeno-pepper-cilantro/"}, {"id": "fda-food-h-1354-2026", "source": "FDA", "category": "food", "recall_number": "H-1354-2026", "title": "Pineapple Mango Salsa Mild. Ingredients: Mango recall (Taylor Fresh Foods Inc)", "product": "Pineapple Mango Salsa Mild. Ingredients: Mango, Pineapple, Pasteurized Lime Juice, Pasteurized Lemon Juice, Jalapeno Pepper, Serrano Pepper, Lime Flavored Zest (***), Lemon Peel (***), Spearmint, Salt. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223075653", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Illinois: 1,056 units; Texas: 1,440 units", "codes": "Illinois: TFIC211, 8/7/2026. Texas: TFTX209U11, 8/7/2026; TFTX211, 8/9/2026; TFTX213U11, 8/11/2026; TFTX216, 8/14/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1354-2026%22", "url": "https://recallledger.net/recalls/food-h-1354-2026-pineapple-mango-salsa-mild-ingredients-mango-pineapple-pasteurized/"}, {"id": "fda-food-h-1353-2026", "source": "FDA", "category": "food", "recall_number": "H-1353-2026", "title": "Mango Pico De Gallo. Ingredients: Mango recall (Taylor Fresh Foods Inc)", "product": "Mango Pico De Gallo. Ingredients: Mango, Red Onion, Tomato, Cilantro, Jalapeno Pepper, Lime Juice. Net Wt: 11 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223073543", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 60 units; Texas: 585 units", "codes": "Tennessee: TFTN2161, 8/13/2026. Texas: TFTX211, 8/8/2026; TFTX213, 8/10/2026; TFTX215U11, 8/12/2026; TFTX216U11, 8/13/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1353-2026%22", "url": "https://recallledger.net/recalls/food-h-1353-2026-mango-pico-de-gallo-ingredients-mango-red-onion-tomato-cilantro/"}, {"id": "fda-food-h-1352-2026", "source": "FDA", "category": "food", "recall_number": "H-1352-2026", "title": "Authentic Guacamole. Ingredients: Guacamole recall (Taylor Fresh Foods Inc)", "product": "Authentic Guacamole. Ingredients: Guacamole, Pico De Gallo. Spec Sheet: Guacamole (Avocado, Pico De Gallo, Lime Juice, Cumin, Salt, Pepper); Pico De Gallo (Cilantro, Jalapeno Pepper, Tomato, Yellow Onion) Net Wt: 13 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223073567", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Texas: 495 units", "codes": "Texas: TFTX211, 8/7/2026; TFTX213, 8/9/2026; TFTX215U11, 8/11/2026; TFTX216U11, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1352-2026%22", "url": "https://recallledger.net/recalls/food-h-1352-2026-authentic-guacamole-ingredients-guacamole-pico-de-gallo-spec-sheet/"}, {"id": "fda-food-h-1351-2026", "source": "FDA", "category": "food", "recall_number": "H-1351-2026", "title": "Spicy Guacamole. Ingredients: Guacamole recall (Taylor Fresh Foods Inc)", "product": "Spicy Guacamole. Ingredients: Guacamole, Pico De Gallo. Spec Sheet: Guacamole (Avocado, Pico De Gallo, Serrano Peper, Lime Juice, Salt, Pepper); Pico De Gallo (Cilantro, Jalapeno Pepper, Tomato, Yellow Onion) Net Wt: 13 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223073574", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 5 units; Texas: 360 units", "codes": "Tennessee: TFTN2171, 8/13/2026. Texas: TFTX211, 8/7/2026; TFTX213, 8/9/2026; TFTX215U11, 8/11/2026; TFTX216U11, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1351-2026%22", "url": "https://recallledger.net/recalls/food-h-1351-2026-spicy-guacamole-ingredients-guacamole-pico-de-gallo-spec-sheet-gu/"}, {"id": "fda-food-h-1350-2026", "source": "FDA", "category": "food", "recall_number": "H-1350-2026", "title": "Fiesta Salad with Shrimp. Ingredients: Salad recall (Taylor Fresh Foods Inc)", "product": "Fiesta Salad with Shrimp. Ingredients: Salad (Romaine Lettuce, Cooked Shrimp *** Pico De Gallo [***Jalapeno Peppers], Fire Roasted Corn, Cooked Black Beans, Lime, Tortilla Strips ***), Creamy Poblano Dressing (***) Net Wt: 11.11 oz. Keep Refrigerated.  Dist. & Sold Exclusively By: Trader Joe's Monrovia, CA 91016.  UPC: 00818377", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Texas: 668 units", "codes": "Texas: TFTX212, 8/7/2026; TFTX213U11, 8/8/2026; TFTX214, 8/9/2026; TFTX215U11, 8/10/2026; TFTX216U11, 8/11/2026; TFTX217U11, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1350-2026%22", "url": "https://recallledger.net/recalls/food-h-1350-2026-fiesta-salad-with-shrimp-ingredients-salad-romaine-lettuce-cooked/"}, {"id": "fda-food-h-1349-2026", "source": "FDA", "category": "food", "recall_number": "H-1349-2026", "title": "Taco Dip. Ingredients: Refried Vegetarian Beans *** Guacamole recall (Taylor Fresh Foods Inc)", "product": "Taco Dip. Ingredients: Refried Vegetarian Beans *** Guacamole (***Pico De Gallo [***Jalapeno Pepper]***), Pico De Gallo (***Jalapeno Pepper), Mild Cheddar Cheese *** Sour Cream *** Black Ripe Olives *** Green Onion, Taco Seasoning Mix *** Net Wt: 20 oz. Keep Refrigerated.  Distributed by: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223073581", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Florida: 260 units; Tennessee: 80 units; Texas: 264 units", "codes": "Florida: TFFL211, 8/7/2026; TFFL212, 8/18/2026; TFFL214, 8/11/2026. Tennessee: TFTN2161, 8/12/2026; TFTN2171, 8/13/2026. Texas: TFTX211, 8/7/2026; TFTX213, 8/9/2026; TFTX215U11, 8/11/2026; TFTX216U11, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1349-2026%22", "url": "https://recallledger.net/recalls/food-h-1349-2026-taco-dip-ingredients-refried-vegetarian-beans-guacamole-pico/"}, {"id": "fda-food-h-1348-2026", "source": "FDA", "category": "food", "recall_number": "H-1348-2026", "title": "Spicy Pimento Cheese Dip. Ingredients: Sharp Cheddar Cheese *** Cream Cheese ***... recall (Taylor Fresh Foods Inc)", "product": "Spicy Pimento Cheese Dip. Ingredients: Sharp Cheddar Cheese *** Cream Cheese *** Piquillo Peppers *** Jalapeno Pepper, Mayonnaise *** Cayenne Pepper Sauce *** Dijon Mustard *** Granulated Garlic, Cayenne Pepper, Pimiento Peppers *** Net Wt: 10 oz. Keep Refrigerated.  Distributed by: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223116448", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Kentucky: 421 units; Texas: 56,028 units", "codes": "Kentucky: TFKY216B, 8/13/2026; TFKY217B, 8/14/2026. Texas: TFTX209, 8/7/2026; TFTX210, 8/8/2026; TFTX211, 8/9/2026; TFTX212, 8/10/2026; TFTX213, 8/11/2026; TFTX214, 8/12/2026; TFTX215, 8/13/2026; TFTX216, 8/14/2026; TFTX217, 8/15/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1348-2026%22", "url": "https://recallledger.net/recalls/food-h-1348-2026-spicy-pimento-cheese-dip-ingredients-sharp-cheddar-cheese-cream/"}, {"id": "fda-food-h-1347-2026", "source": "FDA", "category": "food", "recall_number": "H-1347-2026", "title": "Spicy Jalapeno Jarlsberg Dip. Ingredients: Mayonnaise *** Jarlsberg Cheese *** Red Onion recall (Taylor Fresh Foods Inc)", "product": "Spicy Jalapeno Jarlsberg Dip. Ingredients: Mayonnaise *** Jarlsberg Cheese *** Red Onion, Jalapeno Pepper. Net Wt: 10 oz. Keep Refrigerated.  Distributed By: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223114826", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Kentucky: 832 units; Texas: 59,313 units", "codes": "Kentucky: TFKY216B, 8/13/2026; TFKY217B, 8/14/2026; TFKY218B, 8/15/2026. Texas: TFTX210, 8/7/2026; TFTX211, 8/8/2026; TFTX212, 8/9/2026; TFTX213, 8/10/2026; TFTX214, 8/11/2026; TFTX215, 8/12/2026; TFTX216, 8/13/2026; TFTX217, 8/14/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1347-2026%22", "url": "https://recallledger.net/recalls/food-h-1347-2026-spicy-jalapeno-jarlsberg-dip-ingredients-mayonnaise-jarlsberg-ch/"}, {"id": "fda-food-h-1346-2026", "source": "FDA", "category": "food", "recall_number": "H-1346-2026", "title": "Spicy Roast Beef Sandwich recall (Taylor Fresh Foods Inc)", "product": "Spicy Roast Beef Sandwich (closed-face). Ingredients: Fully Cooked Seasoned Roast Beef Top Round *** Brioche Bun *** Hatch Chile Spread (***Jalapeno Pepper), Red Onion, Fire Roasted Red Pepper Strips*** Net Wt: 8.53 oz. Keep Refrigerated.  Distributed by The Kroger Co. Cincinnati, Ohio 45202.  UPC: 011110678171", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Tennessee: 255 units; Texas: 20,055 units", "codes": "Tennessee: TFTN2171, 8/11/2026. Texas: TFTX211, 8/7/2026; TFTX212, 8/8/2026; TFTX213, 8/9/2026; TFTX214, 8/10/2026; TFTX215, 8/11/2026; TFTX216, 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1346-2026%22", "url": "https://recallledger.net/recalls/food-h-1346-2026-spicy-roast-beef-sandwich-closed-face-ingredients-fully-cooked-sea/"}, {"id": "fda-food-h-1345-2026", "source": "FDA", "category": "food", "recall_number": "H-1345-2026", "title": "Rice & Bean Burrito. Ingredients: Rice recall (Taylor Fresh Foods Inc)", "product": "Rice & Bean Burrito. Ingredients: Rice, Refried Beans, Black Beans, Flame Roasted Corn, Pico De Gallo, Cheese. Net Wt: 12.5 oz. Keep Refrigerated.  Heating Instructions: Microwave: Place in center of the microwave oven. Heat on high for 2-2.5 minutes or 165F. Let rest for 1 minute before serving.  Distributed by: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223082736", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Rhode Island: 638 units", "codes": "Rhode Island: TFNE212A, 8/7/2026; TFNE213A, 8/8/2026; TFNE214A, 8/9/2026; TFNE215A, 8/10/2026; TFNE216A, 8/11/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1345-2026%22", "url": "https://recallledger.net/recalls/food-h-1345-2026-rice-bean-burrito-ingredients-rice-refried-beans-black-beans-fl/"}, {"id": "fda-food-h-1344-2026", "source": "FDA", "category": "food", "recall_number": "H-1344-2026", "title": "Diced Jalapenos. Ingredients: Jalapeno Pepper. Net Wt: 3.75 oz. Keep Refrigerated. ... recall (Taylor Fresh Foods Inc)", "product": "Diced Jalapenos. Ingredients: Jalapeno Pepper. Net Wt: 3.75 oz. Keep Refrigerated.  Distributed by: Taylor Farms Inc., Salinas, CA 93902.  UPC: 030223082712", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Taylor Fresh Foods Inc", "company_location": "Salinas, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: AL, AR, FL, GA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NY, OH, OK, SC, TN, TX, VT, WI, WV. Foreign: Not applicable.", "states": ["AL", "AR", "FL", "GA", "IL", "IN", "KS", "KY", "LA", "MA", "ME", "MI", "MN", "MO", "MS", "NC", "NE", "NH", "NY", "OH", "OK", "SC", "TN", "TX", "VT", "WI", "WV"], "nationwide": false, "quantity": "Rhode Island: 416 units", "codes": "Rhode Island: TFNE210A, 8/9/2026; TFNE213A, 8/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1344-2026%22", "url": "https://recallledger.net/recalls/food-h-1344-2026-diced-jalapenos-ingredients-jalapeno-pepper-net-wt-3-75-oz-keep-r/"}, {"id": "fda-food-h-1343-2026", "source": "FDA", "category": "food", "recall_number": "H-1343-2026", "title": "Mercer's brand 6 ICE CREAM SANDWICHES TO GO recall (Quality Dairy Farms Inc.)", "product": "Mercer's brand 6 ICE CREAM SANDWICHES TO GO; packaged in clear plastic; ice cream sandwiches may be rolled in peanuts which are visible through product packaging  Ingredients: Cream, sugar, nonfat milk, whey, cocoa (alkalized), stabilizer (guar gum, carrageenan), chocolate wafer (wheat flour, sugar, high fructose corn syrup, shortening [partially hydrogenated soybean oil], caramel color, soy flour, corn starch, baking soda, soy lecithin, cocoa, salt, natural vanilla flavor) and/or chocolate chip cookie (Enriched wheat flour [wheat flour, niacin, reduced iron, thiamine, riboflavin, folic acid], palm oil, sugar, chocolate chips [sugar, chocolate liquor, cocoa butter, dextrose, soy lecithin], brown sugar, containers 2% or less of dextrose, salt, leavenings [ammonium bicarbonate, baking soda, sodium acid pyrophosphate], natural flavor) and/or Oreo cookie (unbleached enriched flour (wheat flour, niacin, reduced iron, thiamine mononitrate [vitamin B1], riboflavin [vitamin B2], folic acid), sugar, canola oil, cocoa [processed with alkali], high fructose corn syrup, leavening [baking soda and/or calcium phosphate], salt, soy lecithin, chocolate, artificial flavor.  May contain nuts.  May contain Chocolate Sprinkles (sugar, hydrogenated palm kernel oil, cocoa powder (processed with alkali), corn starch, maltodextrin, cellulose gum, sunflower lecithin, natural and artificial flavor, carnauba wax, vanillin) May contain Carnival Sprinkles (sugar, hydrogenated palm kernel oil, corn starch, sunflower lecithin, FD&C colors (Yellow #6 Lake, Yellow #5 Lake, Blue #1 Lake, Red #40 Lake, Red #3 Dye) maltodextrin, cellulose gum, carnauba wax, vanillin)  Plant #: 36-5692. Boonville, NY  net weight 1.5lb", "reason": "Undeclared peanuts", "hazard_level": "Class II", "company": "Quality Dairy Farms Inc.", "company_location": "Boonville, NY, United States", "date": "2026-08-25", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "NY", "states": ["NY"], "nationwide": false, "quantity": "7 units", "codes": "Codes: 6197 and 6226", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1343-2026%22", "url": "https://recallledger.net/recalls/food-h-1343-2026-mercer-s-brand-6-ice-cream-sandwiches-to-go-packaged-in-clear-plastic/"}, {"id": "fda-food-h-1342-2026", "source": "FDA", "category": "food", "recall_number": "H-1342-2026", "title": "Martina brand Fresh Whole Mangoes recall (Panorama Produce Sales Inc.)", "product": "Martina brand Fresh Whole Mangoes; Individual whole mangoes, variable weight; 9 mangoes per carton box", "reason": "Product may be contaminated with Salmonella", "hazard_level": "Class II", "company": "Panorama Produce Sales Inc.", "company_location": "Mamaroneck, NY, United States", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "CT, NY, NJ, and PA", "states": ["CT", "NJ", "NY", "PA"], "nationwide": false, "quantity": "302 boxes", "codes": "Lot 038, PLU 4584", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1342-2026%22", "url": "https://recallledger.net/recalls/food-h-1342-2026-martina-brand-fresh-whole-mangoes-individual-whole-mangoes-variable/"}, {"id": "fda-food-h-1340-2026", "source": "FDA", "category": "food", "recall_number": "H-1340-2026", "title": "Everything Sprouts Robust Radish Mix recall (Everything Sprouts, LLC)", "product": "Everything Sprouts Robust Radish Mix, Net Wt. 5.0 oz (142 g) UPC 0 87906-00007 5.  Keep Refrigerated.  everythingsprouts.com", "reason": "Sprouts may be contaminated with STEC E. coli and/or Salmonella.", "hazard_level": "Class I", "company": "Everything Sprouts, LLC", "company_location": "Minneapolis, MN, United States", "date": "2026-08-22", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "MN, WI", "states": ["MN", "WI"], "nationwide": false, "quantity": "278.44 lbs.", "codes": "Lot# 223, 226, 230, 233", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1340-2026%22", "url": "https://recallledger.net/recalls/food-h-1340-2026-everything-sprouts-robust-radish-mix-net-wt-5-0-oz-142-g-upc-0-879/"}, {"id": "fda-food-h-1339-2026", "source": "FDA", "category": "food", "recall_number": "H-1339-2026", "title": "Everything Sprouts Crunchy Protein Sprout Mix recall (Everything Sprouts, LLC)", "product": "Everything Sprouts Crunchy Protein Sprout Mix, containing Alfalfa Fenugreek, Cabbage, Mung, Adzuki, Lentils, Green Pea, Net Wt. 5.0 oz (142 g) UPC 0 87906-01018 7.  everythingsprouts.com", "reason": "Sprouts may be contaminated with STEC E. coli and/or Salmonella.", "hazard_level": "Class I", "company": "Everything Sprouts, LLC", "company_location": "Minneapolis, MN, United States", "date": "2026-08-22", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "MN, WI", "states": ["MN", "WI"], "nationwide": false, "quantity": "201.56 pounds", "codes": "Lot# 222, 223, 226, 230", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1339-2026%22", "url": "https://recallledger.net/recalls/food-h-1339-2026-everything-sprouts-crunchy-protein-sprout-mix-containing-alfalfa-fenu/"}, {"id": "fda-food-h-1338-2026", "source": "FDA", "category": "food", "recall_number": "H-1338-2026", "title": "Everything Sprouts Zesty Garlic Mix recall (Everything Sprouts, LLC)", "product": "Everything Sprouts Zesty Garlic Mix, containing Garlic, Onion and Alfalfa Sprouts, Net Wt. 5.0 oz (142 g) UPC 0 87906-00016 7.  everythingsprouts.com", "reason": "Sprouts may be contaminated with STEC E. coli and/or Salmonella.", "hazard_level": "Class I", "company": "Everything Sprouts, LLC", "company_location": "Minneapolis, MN, United States", "date": "2026-08-22", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "MN, WI", "states": ["MN", "WI"], "nationwide": false, "quantity": "163.44 pounds", "codes": "Lot# 222, 223, 225, 226, 230.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1338-2026%22", "url": "https://recallledger.net/recalls/food-h-1338-2026-everything-sprouts-zesty-garlic-mix-containing-garlic-onion-and-alfa/"}, {"id": "fda-food-h-1337-2026", "source": "FDA", "category": "food", "recall_number": "H-1337-2026", "title": "Everything Sprouts and Calco branded Alfalfa Sprouts recall (Everything Sprouts, LLC)", "product": "Everything Sprouts and Calco branded Alfalfa Sprouts, Net Wt. 5.0 oz (142 g) UPC 7 68944-00005 9.  The 5 oz. containers are distributed as single units, or in a tray with 6 - 5oz containers that contains UPC 8 60014-52312 0 label on bottom of tray, or in a try with 12 - 5 oz. containers that contains UPC 8 60014-52311 3 label on bottom of tray.", "reason": "Sprouts may be contaminated with STEC E. coli and/or Salmonella.", "hazard_level": "Class I", "company": "Everything Sprouts, LLC", "company_location": "Minneapolis, MN, United States", "date": "2026-08-22", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "MN, WI", "states": ["MN", "WI"], "nationwide": false, "quantity": "1,830.25 pounds", "codes": "LOT #222, 223, 225, 226, 230", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1337-2026%22", "url": "https://recallledger.net/recalls/food-h-1337-2026-everything-sprouts-and-calco-branded-alfalfa-sprouts-net-wt-5-0-oz/"}, {"id": "fda-food-h-1336-2026", "source": "FDA", "category": "food", "recall_number": "H-1336-2026", "title": "Foods Alive organic moringa leaf powder recall (FOODS ALIVE INC.)", "product": "Foods Alive organic moringa leaf powder, 8oz pouch, UPC 8 91551 00092 8", "reason": "Potential Salmonella contamination", "hazard_level": "Class I", "company": "FOODS ALIVE INC.", "company_location": "Angola, IN, United States", "date": "2026-08-26", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Nationwide US and UAE.  The recalled organic moringa leaf powder was distributed nationwide in retail stores and through online sellers including but not limited to www.foodsalive.com.", "states": [], "nationwide": true, "quantity": "1691 pouches", "codes": "Freshest by 110127", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1336-2026%22", "url": "https://recallledger.net/recalls/food-h-1336-2026-foods-alive-organic-moringa-leaf-powder-8oz-pouch-upc-8-91551-00092/"}, {"id": "fda-drug-d-0866-2026", "source": "FDA", "category": "drug", "recall_number": "D-0866-2026", "title": "Thyroid Tablets recall (VITRUVIAS THERAPEUTICS INC)", "product": "Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.", "reason": "Superpotent Drug", "hazard_level": "Class I", "company": "VITRUVIAS THERAPEUTICS INC", "company_location": "Auburn, AL, United States", "date": "2026-08-21", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "1955 bottles", "codes": "Lot # 504950, Exp Date: 09/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2026%22", "url": "https://recallledger.net/recalls/drug-d-0866-2026-thyroid-tablets-usp-1-2-grain-30-mg-each-tablet-contains-levothy/"}, {"id": "fda-drug-d-0848-2026", "source": "FDA", "category": "drug", "recall_number": "D-0848-2026", "title": "Lidocaine Ointment USP recall (SUN PHARMA /TARO)", "product": "Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5", "reason": "Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).", "hazard_level": "Class II", "company": "SUN PHARMA /TARO", "company_location": "Hawthorne, NY, United States", "date": "2026-08-31", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "65,328 50g jars", "codes": "Lot # AD48154, Exp: 4/30/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0848-2026%22", "url": "https://recallledger.net/recalls/drug-d-0848-2026-lidocaine-ointment-usp-5-speermint-flavor-50-g-jar-rx-only-mfd/"}, {"id": "fda-drug-d-0846-2026", "source": "FDA", "category": "drug", "recall_number": "D-0846-2026", "title": "Fluphenazine HCl Elixir recall (Safecor Health, LLC)", "product": "Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801.  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NDC:  00121-0653-04", "reason": "Failed Stability Specifications", "hazard_level": "Class II", "company": "Safecor Health, LLC", "company_location": "Woburn, MA, United States", "date": "2026-08-13", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Nationwide in the USA.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot#:26080483; Exp :03/13/2027  Lot#:25310327; Exp :08/12/2026  Lot#:25330414; Exp :08/26/2026  Lot#:25430340; Exp :11/22/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0845-2026%22", "url": "https://recallledger.net/recalls/drug-d-0845-2026-fluphenazine-hcl-elixir-usp-15-mg-per-3-ml-delivers-10-ml-oral-el/"}, {"id": "fda-drug-d-0844-2026", "source": "FDA", "category": "drug", "recall_number": "D-0844-2026", "title": "Fluphenazine HCl Elixir recall (Safecor Health, LLC)", "product": "Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801.  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"REF:B12LT  Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)", "product": "REF:B12LT  Ethicon Endo-Surgery, Inc.   XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM", "reason": "Reusable access port system may crack or seperate during use.", "hazard_level": "Class II", "company": "Stryker Sustainability Solutions", "company_location": "Tempe, AZ, United States", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina\t, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of  Israel and Canada.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "2682 units", "codes": "UDI: (01)00885825020897/ Lots: 16029001 16032878  16038822  16041414  16044000  16048542  16052751  16054119  16062169  16062738  16066292 16074632  16087947  16087952  16090650  16098040  16107246  16111434  16115899  16115909  16120868 16130680  16130701  16135456  16136279  16138395  16140432  16140568  16142544  16142619  16159304 16160563  16172080  16176548  16186738  16186874  16187194  16187248  16187457  16197336  16201786 16205783  16205810  16205823  16206753  16220653  16220918  16221448  16221453", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3185-2026%22", "url": "https://recallledger.net/recalls/device-z-3185-2026-ref-b12lt-ethicon-endo-surgery-inc-xcel-bladeless-trocar-w-stabil/"}, {"id": "fda-device-z-3184-2026", "source": "FDA", "category": "device", "recall_number": "Z-3184-2026", "title": "REF:B11LT  Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)", "product": "REF:B11LT  Ethicon Endo-Surgery, Inc.   XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM", "reason": "Reusable access port system may crack or seperate during use.", "hazard_level": "Class II", "company": "Stryker Sustainability Solutions", "company_location": "Tempe, AZ, United States", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina\t, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of  Israel and Canada.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "25746 units", "codes": "UDI: (01)00885825014278/ Lots: 16029055 16032602  16043960  16061865  16070321  16087746  16098637  16110046  16114368  16130717  16135711 16143130  16146135  16151146  16160441  16168393  16176147  16181210  16193613  16193841  16197273 16210637  16225560  16234068  16243073  16255238  16270273  16281198  16288334  16294565  16297693 16298302  16330851  16331282  16343635  16347401  16371411  16371424  16388088  16403183  16403718 16414106  16427432  16431368  16447949  16467342  16477495  16487698  16494506  16500580  16508571 16521742  16532270  16535613  16535744  16548007  16555888  16570108  16574637  16587696  16587715 16590797  16599333  16599403  16604291  16608764  16623439  16633133  16645377  16651357  16652029 16655384  16665681  16674817  16675666  16705350  16705494  16713074  16716790  16721202  16729496 16745595  16746009  16759208  16763700  16774402  16778721  16793395  16796870  16806597  16813889 16818038  16826959  16830829  16841701  16845712  16850270  16854348  16864262  16873298  16882066 16890447  16910583  16911077  16918348  16932643  16932670  16944854  16948846  16954589  16954752 16960057  16973101  16997240  17001744  17028440  17028570  17031601  17041299  17049923  17059628 17066538  17076463  17088783  17095646  17109581  17113435  17135548  17139463  17150688  17151102 17169646  17170177  17204941  17205450  17209368  17209375  17227100  17251065  17254141  17263845 17271186  17271210  17281823  17294417  17299147  17322114  17328034  17341513  17368858  17390430 17403535  17403664  17403934  17425110  17429906  17449215  17469249  17473233  17481923  17505258 17505372  17526291  17540762  17551599  17565554  17581089  17596921  17608897  17609204  17623498 17630896  17655989  17669388  17688040  17691616", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3184-2026%22", "url": "https://recallledger.net/recalls/device-z-3184-2026-ref-b11lt-ethicon-endo-surgery-inc-xcel-bladeless-trocar-w-stabil/"}, {"id": "fda-device-z-3183-2026", "source": "FDA", "category": "device", "recall_number": "Z-3183-2026", "title": "REF:2B5ST  Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)", "product": "REF:2B5ST  Ethicon Endo-Surgery, Inc.   XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM", "reason": "Reusable access port system may crack or seperate during use.", "hazard_level": "Class II", "company": "Stryker Sustainability Solutions", "company_location": "Tempe, AZ, United States", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina\t, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of  Israel and Canada.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "2838 units", "codes": "UDI: (01)00885825017231/ Lots: 16188647 16210212  16243934  16267300  16285639 16285656  16306188  16306231  16364978  16470903 16521533         16547722  16580202  16599810  16637989 16656930         16665550  17005619  17069758  17113276  17117460 17146892  17172722  17389157", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3183-2026%22", "url": "https://recallledger.net/recalls/device-z-3183-2026-ref-2b5st-ethicon-endo-surgery-inc-xcel-bladeless-trocar-w-optivi/"}, {"id": "fda-device-z-3182-2026", "source": "FDA", "category": "device", "recall_number": "Z-3182-2026", "title": "REF:2B5LT  Ethicon Endo-Surgery recall (Stryker Sustainability Solutions)", "product": "REF:2B5LT  Ethicon Endo-Surgery, Inc.   XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM", "reason": "Reusable access port system may crack or seperate during use.", "hazard_level": "Class II", "company": "Stryker Sustainability Solutions", "company_location": "Tempe, AZ, United States", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina\t, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of  Israel and Canada.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "7,5966 units", "codes": "UDI: (01)00885825017248/ Lots: 16029709 16029713 16029905  16038879  16038908 16048968 16048981   16051646  16052906  16053263 16070603 16070983   16074134  16074530  16074759 16092016 16092379   16092572  16104843  16106180 16119023 16119800   16121093  16126431  16126844 16140581 16140608   16140727  16140736  16142688 16160592 16160707   16160912  16161351  16167914 16180911 16188469   16189136  16197549  16210951 16244569 16247119   16247126  16250185  16255569 16267787 16273355   16284965  16303304  16306443 16359846 16360045   16360239  16360667  16364426 16383244 16383259   16384055  16396887  16397027 16427445 16435623   16435843  16436420  16436477 16444099 16444580   16444611  16448679  16448717 16459282 16459305   16459333  16459564  16470988 16488281 16491642   16492270  16492579  16492580 16500270 16500301   16500355  16500477  16508036 16528627 16528847   16531603  16531776  16531851 16552151 16552167   16552179  16552302  16555583 16614437 16614471   16618155  16626048  16637792 16646115 16651856   16652489  16657339  16662201 16682817 16701240   16713799  16713813  16716081 16738446 16746148   16754258  16754364  16759556 16773257 16774058   16774101  16774234  16782321 16800707 16806623   16806634  16806725  16814724 16830838 16841362   16841565  16845689  16854686 16873543 16882583   16883091  16889712  16899476 16911147 16914777   16918170  16918780  16923307 16940703 16944189   16948321  16952138  16952313 16977312 16981100   16981383  16981401  16985146 17001229 17005661   17010282  17010765  17010777 17033172 17035546   17040809  17041439  17045802 17063970 17064018   17080237  17085115  17085162 17108912 17109146   17109620  17112702  17121236 17139503 17139820   17147232  17150268  17150996 17174600 17175063   17175092  17175156  17178723 17185753 17185920   17189274  17189482  17189760 17200395 17200428  17200459   17209470  17209525 17232002 17235037  17235643   17235658  17239757 17251106 17258526  17258722   17258808  17258820 17275106 17289383  17289591   17289995  17294320 17310764 17325423  17325475   17327721  17327882 17341993 17345967  17346016   17353315  17353701 17369590 17369751  17378860   17378873  17378943 17390891 17391078  17391084   17408075  17408145 17420057 17420185  17430762   17431184  17431364 17449546 17456945  17469587   17473527  17473747 17496222 17500265  17511819   17521462  17525917 17541289 17545348  17545353   17551198  17551484 17576887 17608061  17608438   17608799  17614359", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3182-2026%22", "url": "https://recallledger.net/recalls/device-z-3182-2026-ref-2b5lt-ethicon-endo-surgery-inc-xcel-bladeless-trocar-w-optivi/"}, {"id": "fda-device-z-3177-2026", "source": "FDA", "category": "device", "recall_number": "Z-3177-2026", "title": "Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT  Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT... recall (Wilson-Cook Medical Inc.)", "product": "Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT  Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT  Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU  Software Version: N/A  Product Description: Hemostatic device for endoscopic gastrointestinal use  Component: No", "reason": "Due to issue with endoscope adherence and inability to spray powder.  Firm will provide an updated Instruction for Use (IFU).", "hazard_level": "Class II", "company": "Wilson-Cook Medical Inc.", "company_location": "Winston Salem, NC, United States", "date": "2026-08-20", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Brazil, Canada, Canary Island, Chile, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guatemala, Guadeloupe, Guernsey, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jersey, Japan, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Martinique, Mexico, Myanmar, Macau, Monaco, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, El Salvador, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, United Arab Emirates, United Kingdom, and Vietnam.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "121,241 units (U.S.-49240, O.U.S.-72001)", "codes": "Lot Code: RPN: IHEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU  Order Number: G56572, G21049, G24663, G21346  Affected Lot Numbers and MFG/EXP Dates: The information supplied in this letter applies to all lot numbers of Hemospray. UDI: 00827002565722; 00827002210493; 00827002246638; 00827002213463  HEMO-7 Work Order Numbers: W4744012 W4744013 W4744014 W4744015 W4744016 W4744017 W4744103 W4744104 W4744504 W4744506 W4744507 W4744508 W4744509 W4744510 W4744511 W4744575 W4744576 W4744828 W4744829 W4744830 W4744831 W4744832 W4744834 W4744905 W4744906 W4745140 W4745141 W4745142 W4745144 W4745145 W4745146 W4745147 W4745262 W4745263 W4745408 W4745409 W4745411 W4745412 W4745488 W4745489 W4746024 W4746025 W4746026 W4746027 W4746028 W4746029 W4746030 W4746494 W4746495 W4746496 W4746497 W4746498 W4746499 W4746500 W4746639 W4746640 W4746909 W4746910 W4746911 W4746912 W4746913 W4746915 W4747100 W4747374 W4747375 W4747377 W4747378 W4747379 W4747380 W4747381 W4747802 W4747803 W4747805 W4747806 W4747807 W4748859 W4748860 W4748865 W4748866 W4748930 W4748931 W4749220 W4749221 W4749222 W4749223 W4749224 W4749225 W4749226 W4749422 W4749423 W4749736 W4749737 W4749738 W4749739 W4749740 W4749741 W4749742 W4749971 W4749972 W4749995 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W4979472 W4979473 W4979474 W4979475 W4979476 W4979477 W4979478 W4979479 W4979480 W4979925 W4979926 W4979928 W4979929 W4979930 W4980700 W4980701 W4980704 W4980705 W4981177 W4981178 W4981179 W4981180 W4981819 W4981820 W4981821 W4981822 W4981823 W4981824 W4981825 W4981826 W4981827 W4981828 W4981829 W4981832 W4981833 W4981834 W4982707 W4982708 W4982709 W4982710 W4982712 W4982713 W4982716 W4982717 W4982718 W4982719 W4982720 W4982721 W4982722 W4983342 W4983343 W4983344 W4983345 W4983346 W4983347 W4983348 W4983349 W4983350 W4983351 W4984136 W4984137 W4984138 W4984140 W4984141 W4984142 W4984143 W4984144 W4984145 W4984146 W4984149 W4984150 W4984804 W4984805 W4984806 W4984807 W4984808 W4984809 W4984810 W4984811 W4986046 W4986049 W4986050 W4986051 W4986052 W4986055 W4986056 W4986057 W4986058 W4986536 W4986537 W4986538 W4986667 W4986668 W4986669 W4986670 W4986671 W4986672 W4986674 W4986675 W4986676 W4986677 W4986679 W4986680 W4986681 W4987450 W4987451 W4987452 W4987453 W4987454 W4987455 W4987456 W4987457 W4988082 W4988083 W4988084 W4988085 W4988086 W4988087 W4988088 W4988092 W4988093 W4988094 W4988575 W4988576 W4988577 W4988578 W4988793 W4988794 W4988795 W4988796 W4988797 W4988798 W4988799 W4988800 W4988801 W4988802 W4988803 W4988804 W4988805 W4988806 W4988807 W4989801 W4989803 W4989804 W4989805 W4989806 W4989807 W4989809 W4989810 W4989811 W4989812 W4989813 W4990674 W4990885 W4990886 W4990887 W4990888 W4990889 W4990890 W4990891 W4990892 W4990893 W4990894 W4990895 W4990896 W4990897 W4990898 W4990899 W4990900 W4991925 W4991926 W4991927 W4991928 W4991944 W4991947 W4991948 W4991950 W4991951 W4991952 W4991953 W4991954 W4991955 W4992538 W4992539 W4992540 W4992541 W4992542 W4992543 W4992545 W4992546 W4992547 W4992561 W4992976 W4992977 W4992978 W4992979 W4992980 W4992981 W4992982 W4993267 W4993268 W4993412 W4993413 W4993415 W4993416 W4993417 W4993574 W4993575 W4993577 W4993578 W4993579 W4993580 W4993581 W4993582 W4993583 W4993584 W4993585 W4993586 W4993589 W4993590 W4994181 W4994182 W4994254 W4994255 W4994317 W4994318 W4994319 W4994320 W4994321 W4994322 W4994324 W4994325 W4994326 W4994327 W4994328 W4994541 W4994603 W4994604 W4994605 W4994606 W4994607 W4994608 W4994611 W4994612 W4994613 W4994940 W4994941 W4994942 W4994943 W4994944 W4995004 W4995005 W4995251 W4995252 W4995253 W4995254 W4995255 W4995256 W4995258 W4997025 W4997027 W4997028 W4997029 W4997030 W4997031 W4997032 W4997033 W4997467 W4997468 W4997469 W4997470 W4997472 W4997473 W4997474 W4997475 W4997476 W4997816 W4997817 W4997818 W4997819 W4997821 W4998180 W4998182 W4998183 W4998184 W4998185 W4998186 W4998187 W4998551 W4998552 W4998553 W4998554 W4998555 W4998556 W4998737 W4998738 W4998877 W4998878 W4998879 W4998880 W4998881 W4998882 W4998884 W4998885 W4998886 W4999171 W4999172 W4999173 W4999174 W4999175 W4999176 W4999177 W4999179 W4999596 W4999597 W4999598 W4999599 W4999600 W4999601 W4999602 W4999603 W4999604 W4999968 W4999969 W4999970 W4999971 W4999972 W4999973 W4999975 W4999976 W4999977 W5000314 W5000315 W5000316 W5000317 W5000318 W5000319 W5000320 W5000323 W5000676 W5000677 W5000678 W5000679 W5000680 W5000681 W5000682 W5000683 W5000684 W5000685 W5001004 W5001005 W5001006 W5001007 W5001008 W5001009 W5001010 W5001011 W5001012 W5001013 W5001403 W5001404 W5001405 W5001406 W5001407 W5001408 W5001409 W5001410 W5001411 W5001412 W5001605 W5001606 W5001754 W5001755 W5001756 W5001757 W5001758 W5001759 W5001760 W5001761 W5001762 W5001763 W5002183 W5002184 W5002185 W5002186 W5002187 W5002188 W5002189 W5002190 W5002191 W5002192 W5002666 W5002667 W5002668 W5002669 W5002670 W5002671 W5002672 W5002673 W5002674 W5002675 W5002969 W5002970 W5002971 W5002972 W5002973 W5003296 W5003297 W5003298 W5003299 W5003300 W5003301 W5003302 W5003303 W5003304 W5003305 W5003611 W5003612 W5003613 W5003614 W5003615 W5003616 W5003683 W5003684 W5003685 W5003686 W5003687 W5003855 W5003858 W5003859 W5004324 W5004326 W5004327 W5004328 W5004330 W5004331 W5004332 W5004333 W5004549 W5004550 W5004734 W5004735 W5004737 W5004738 W5004740 W5004741 W5004742 W5004743 W5005062 W5005065 W5005067 W5005068 W5005069 W5005070 W5005071 W5005315 W5005316 W5005554 W5005555 W5005558 W5005559 W5005560 W5005561 W5005562 W5005563 W5005691 W5005692 W5005693 W5005722 W5005723 W5005724 W5005828 W5005829 W5005831 W5005832 W5005833 W5005834 W5005835 W5005836 W5005837 W5006132 W5006133 W5006134 W5006293 W5006294 W5006295 W5006296 W5006297 W5006298 W5006301 W5006302 W5006303 W5006304 W5006305 W5006569 W5006570 W5006571 W5006572 W5006858 W5006859 W5006860 W5006861 W5006862 W5006863 W5006865 W5006866 W5007106 W5007107 W5007108 W5007109 W5007116 W5007117 W5007119 W5007153 W5007154 W5007155 W5007156 W5007157 W5007158 W5007259 W5007260 W5007261 W5007405 W5007406 W5007588 W5007589 W5007590 W5007591 W5007593 W5007594 W5007595 W5007596 W5007597 W5007856 W5007857 W5007858 W5007877 W5007989 W5007990 W5007991 W5007993 W5007994 W5007995 W5007996 W5007997 W5007998 W5007999 W5008000 W5008241 W5008242 W5008390 W5008391 W5008392 W5008393 W5008395 W5008396 W5008397 W5008398 W5008399 W5008400 W5008401 W5008646 W5008647 W5008648 W5008652 W5008764 W5008765 W5008766 W5008767 W5008768 W5008769 W5008770 W5008771 W5008772 W5008773 W5008774 W5008775 W5009030 W5009135 W5009137 W5009138 W5009139 W5009140 W5009141 W5009142 W5009143 W5009144 W5009145 W5009147 W5009474 W5009475 W5009476 W5009477 W5009478 W5009479 W5009480 W5009481 W5009482 W5009483 W5009484 W5009552 W5009553 W5009789 W5009790 W5009791 W5009885 W5009886 W5009887 W5009888 W5009890 W5009891 W5009892 W5009893 W5009894 W5009895 W5009896 W5009897 W5010151 W5010152 W5010153 W5010554 W5010555 W5010556 W5010557 W5010558 W5010561 W5010562 W5010563 W5010564 W5010565 W5010773 W5010774 W5010775 W5010794 W5010795 W5010881 W5010882 W5010886 W5010887 W5010888 W5010889 W5010890 W5011145 W5011146 W5011147 W5011229 W5011230 W5011231 W5011232 W5011233 W5011234 W5011235 W5011236 W5011237 W5011238 W5011239 W5011240 W5011606 W5011609 W5011610 W5011611 W5011612 W5011613 W5011614 W5011615 W5014765 W5014766 W5014767 W5014768 W5014769 W5014770 W5014771 W5015174 W5015175 W5015176 W5015177 W5015507 W5015508 W5015509 W5015510 W5015757 W5015969 W5015970 W5015971 W5015972 W5015973 W5015974 W5015977 W5015978 W5015979 W5015980 W5015981 W5015982 W5016393 W5016406 W5016407 W5016408 W5016409 W5016410 W5016411 W5016412 W5016413 W5016414 W5016415 W5016752 W5016753 W5016754 W5016755 W5016756 W5016759 W5016760 W5016761 W5016762 W5016763 W5016764 W5017166 W5017167 W5017191 W5017192 W5017193 W5017194 W5017195 W5017198 W5017199 W5017200 W5017201 W5017202 W5017499 W5017500 W5017501 W5017502 W5017505 W5017506 W5017507 W5017508 W5017976 W5017977 W5017978 W5017979 W5017980 W5017981 W5017982 W5017983 W5017984 W5017985 W5017986 W5017987 W5017988 W5017989 W5017990 W5018372 W5018373 W5018374 W5018375 W5018376 W5018377 W5018378 W5018379 W5018380 W5018381 W5018614 W5018615 W5018768 W5018772 W5018773 W5018774 W5018775 W5018776 W5018777 W5018778 W5018779 W5019934 W5019935 W5019936 W5019937 W5019938 W5019939 W5019940 W5019941 W5020298 W5020299 W5020300 W5020301 W5020302 W5020303 W5020304 W5020305 W5020306 W5020307 W5020719 W5020720 W5020721 W5020722 W5020723 W5020724 W5020725 W5020726 W5020727 W5020728 W5021081 W5021082 W5021083 W5021084 W5021085 W5021086 W5021087 W5021088 W5021346 W5021347 W5021348 W5021349 W5021350 W5021351 W5021352 W5021353 W5021831 W5021832 W5021833 W5021834 W5021835 W5022179 W5022180 W5022181 W5022182 W5022183 W5022184 W5022185 W5022576 W5022577 W5022578 W5022579 W5022580 W5024389 W5024390 W5024391 W5024392 W5024393 W5024394 W5024395 W5024396 W5024397 W5024398 W5024671 W5024672 W5024673 W5024674 W5024675 W5024676 W5025289 W5025290 W5025291 W5025292 W5025456 W5025457 W5025458 W5025459 W5025460 W5025461 W5025462 W5025463 W5025464 W5025465 W5025466 W5025749 W5025750 W5025843 W5025844 W5025845 W5025846 W5025847 W5025848 W5025849 W5025850 W5025851 W5025852 W5025853 W5026290 W5026291 W5026292 W5026293 W5026294 W5026295 W5026296 W5026297 W5026300 W5026301 W5026727 W5026728 W5026729 W5026730 W5026732 W5026733 W5026734 W5026735 W5026736 W5026737 W5026738 W5027125 W5027126 W5027127 W5027128 W5027129 W5027130 W5027131 W5027133 W5027194 W5027481 W5027482 W5027483 W5027484 W5027485 W5027486 W5027487 W5027488 W5027896 W5027897 W5027898 W5027899 W5027900 W5027901 W5027902 W5027903 W5027904 W5027905 W5027906 W5027907 W5028271 W5028272 W5028273 W5028274 W5028275 W5028276 W5028277 W5028278 W5028279 W5028280 W5028612 W5028613 W5028614 W5028615 W5028616 W5028617 W5028618 W5028619 W5028808 W5028809 W5028810 W5028811 W5029291 W5029292 W5029293 W5029294 W5029295 W5029296 W5029297 W5029298 W5029299 W5029300 W5029511 W5029512 W5029645 W5029646 W5029647 W5029648 W5029649 W5029650 W5029651 W5029652 W5029653 W5029654 W5030058 W5030059 W5030060 W5030061 W5030062 W5030063 W5030064 W5030065 W5030066 W5030067 W5030131 W5030132 W5030317 W5030318 W5030319 W5030422 W5030423 W5030424 W5030425 W5030426 W5030427 W5030428 W5030429 W5030430 W5030431 W5030432 W5030733 W5030734 W5030735 W5030738 W5030739 W5030740 W5030741 W5030742 W5031208 W5031209 W5031210 W5031211 W5031212 W5031213 W5031214 W5031215 W5031216 W5031217 W5031609 W5031611 W5031612 W5031613 W5031614 W5031615 W5031616 W5031617 W5031618 W5031936 W5031937 W5031940 W5031941 W5031942 W5031943 W5031944 W5031945 W5032376 W5032377 W5032378 W5032379 W5032380 W5033549 W5033550 W5033551 W5033552 W5033711 W5033712 W5033713 W5033714 W5033715 W5033717 W5033718 W5033719 W5033720 W5033953 W5033954 W5033955 W5033957 W5033958 W5033959 W5033961 W5033962 W5033963 W5034451 W5034452 W5034453 W5034454 W5034457 W5034458 W5034459 W5034468 W5034469 W5034814 W5034815 W5034816 W5034817 W5034818 W5034819 W5034820 W5035281 W5035282 W5035283 W5035284 W5035285 W5035286 W5035287 W5035288 W5035289 W5035290 W5035291 W5035749 W5035750 W5035751 W5035752 W5035753 W5035754 W5035755 W5035756 W5035789 W5035790 W5036027 W5036028 W5036234 W5036237 W5036238 W5036239 W5036240 W5036241 W5036242 W5036243 W5036244 W5036625 W5036626 W5036627 W5036628 W5036629 W5036630 W5036631 W5036632 W5036633 W5036634 W5036635 W5037162 W5037165 W5037166 W5037167 W5037168 W5037169 W5037170 W5037171 W5037172 W5037389 W5037391 W5037393 W5037394 W5037395 W5037701 W5037704 W5037705 W5037706 W5037707 W5038066 W5038067 W5038068 W5038069 W5038070 W5038071 W5038072 W5038073 W5038075 W5038738 W5038739 W5038740 W5038741 W5038742 W5038743 W5038744 W5038746 W5038747 W5038748 W5038987 W5038988 W5038989 W5038990 W5038991 W5038992 W5038993 W5038994 W5038995 W5038997 W5039482 W5039483 W5039484 W5039485 W5039486 W5039487 W5039488 W5039489 W5039490 W5039492 W5039909 W5039910 W5039911 W5039912 W5039913 W5039914 W5039915 W5039916 W5039917 W5039918 W5040065 W5040270 W5040272 W5040273 W5040274 W5040275 W5040276 W5040277 W5040278 W5040279 W5040683 W5040684 W5040685 W5040686 W5040687 W5040690 W5040691 W5040692 W5040693 W5041030 W5041031 W5041032 W5041033 W5041034 W5041035 W5041036 W5041037 W5041039 W5041040 W5041041 W5041444 W5041445 W5041446 W5041447 W5041448 W5041449 W5041450 W5041451 W5041452 W5041453 W5041774 W5041775 W5041776 W5041777 W5041778 W5041779 W5041782 W5041783 W5041784 W5041785 W5042217 W5042218 W5042219 W5042221 W5042222 W5042223 W5042224 W5042225 W5042226 W5042227 W5042228 W5042280 W5042281 W5042587 W5042588 W5042589 W5042590 W5042591 W5042592 W5042593 W5042597 W5042598 W5043985 W5043986 W5043987 W5043988 W5044005 W5044006 W5044007 W5044161 W5044162 W5044163 W5044164 W5044165 W5044166 W5044167 W5044168 W5044170 W5044171 W5044172 W5044517 W5044518 W5044520 W5044521 W5044522 W5044523 W5044524 W5044525 W5044526 W5044733 W5044734 W5044735 W5044736 W5044739 W5044740 W5044741 W5044742 W5044743 W5044744 W5045157 W5045158 W5045159 W5045160 W5045161 W5045162 W5045163 W5045164 W5045167 W5045168 W5045218 W5045219 W5045584 W5045585 W5045586 W5045587 W5045588 W5045589 W5045590 W5045591 W5045592 W5045593 W5045817 W5045818 W5046017 W5046020 W5046021 W5046022 W5046023 W5046024 W5046025 W5046026 W5046028 W5046353 W5046358  HEMO-7-EU Work Order Numbers: W4746023 W4748864 W4752341 W4753452 W4754738 W4756537 W4758709 W4758877 W4759471 W4759472 W4761285 W4762110 W4762111 W4765583 W4778190 W4781472 W4781590 W4781857 W4781858 W4781859 W4781860 W4781861 W4782252 W4782253 W4782256 W4782258 W4783155 W4788605 W4792778 W4795607 W4800644 W4801576 W4803792 W4816445 W4830881 W4844245 W4847501 W4851589 W4887117 W4889216 W4891395 W4892630 W4894979 W4897281 W4899480 W4900433 W4913887 W4915431 W4915858 W4916702 W4916704 W4916801 W4918737 W4920732 W4923241 W4925229 W4926708 W4927127 W4928892 W4929988 W4930746 W4931226 W4932903 W4934879 W4938757 W4941669 W4948572 W4948573 W4948957 W4948958 W4949385 W4949701 W4949702 W4951231 W4951232 W4955032 W4955033 W4955034 W4955035 W4955036 W4955037 W4955038 W4955365  HEMO-10 Work Order Numbers: W4744018 W4744019 W4744505 W4744833 W4744835 W4745143 W4745410 W4745413 W4745414 W4745415 W4746493 W4746908 W4746914 W4747376 W4747804 W4747808 W4748861 W4748862 W4748863 W4749219 W4749735 W4750253 W4750258 W4750613 W4750615 W4750620 W4751073 W4751074 W4751500 W4751505 W4751506 W4751896 W4751902 W4751903 W4752344 W4752345 W4752346 W4753003 W4753455 W4753883 W4753884 W4754327 W4754328 W4754736 W4754737 W4755188 W4755189 W4755651 W4756178 W4756179 W4756859 W4756863 W4757942 W4757954 W4758401 W4758708 W4758876 W4758883 W4759470 W4759474 W4759475 W4759967 W4759968 W4760431 W4760432 W4761291 W4761292 W4761864 W4761865 W4762112 W4762586 W4762959 W4763474 W4763475 W4763476 W4763911 W4763912 W4765578 W4765582 W4766139 W4766585 W4766586 W4767047 W4767048 W4767567 W4767569 W4767791 W4767793 W4768284 W4768285 W4768812 W4768813 W4769284 W4769377 W4769797 W4770235 W4770535 W4770538 W4771159 W4771160 W4771489 W4771495 W4771982 W4772412 W4772413 W4772851 W4772856 W4773258 W4773264 W4773798 W4774156 W4774157 W4774515 W4774519 W4775047 W4775049 W4775564 W4775565 W4775572 W4776376 W4776377 W4776731 W4776735 W4777632 W4777638 W4778191 W4778192 W4778612 W4778614 W4779502 W4779508 W4780015 W4780019 W4780944 W4780945 W4780973 W4780974 W4781477 W4782689 W4782691 W4783152 W4783153 W4783296 W4783297 W4783526 W4784034 W4784039 W4785373 W4785452 W4785766 W4785769 W4785984 W4786260 W4786261 W4786778 W4786779 W4787090 W4787091 W4787623 W4788604 W4789033 W4789039 W4789823 W4789824 W4790339 W4790340 W4790345 W4790346 W4790696 W4790875 W4790876 W4791251 W4791703 W4791704 W4791708 W4791837 W4792719 W4792777 W4792780 W4793466 W4793467 W4794170 W4794623 W4795347 W4795348 W4795606 W4796506 W4796947 W4797332 W4797333 W4797845 W4798245 W4798743 W4798744 W4799204 W4799205 W4799815 W4800182 W4800187 W4800642 W4800643 W4800868 W4800869 W4801582 W4802145 W4802146 W4802559 W4802560 W4803011 W4803433 W4803793 W4803794 W4804384 W4804385 W4804768 W4804769 W4805186 W4805715 W4805716 W4806101 W4806102 W4806280 W4806530 W4807160 W4807166 W4807463 W4807933 W4808332 W4808886 W4809361 W4809366 W4809699 W4809700 W4810031 W4810513 W4810517 W4810518 W4811128 W4811594 W4811595 W4811953 W4811954 W4812314 W4812663 W4812664 W4812665 W4813113 W4813674 W4813675 W4814348 W4814349 W4814694 W4815149 W4815150 W4815725 W4815726 W4815993 W4815997 W4816440 W4816444 W4816737 W4817195 W4817202 W4817204 W4817589 W4817591 W4818010 W4818011 W4818789 W4819287 W4819288 W4819713 W4819714 W4820425 W4820737 W4820743 W4821172 W4821179 W4821552 W4821925 W4821928 W4822274 W4822279 W4822536 W4822964 W4823342 W4823343 W4823349 W4823698 W4823700 W4824137 W4824141 W4824142 W4824408 W4824711 W4824712 W4825127 W4825501 W4825503 W4825504 W4825864 W4826535 W4826536 W4827170 W4827577 W4827578 W4827916 W4827917 W4828265 W4828688 W4829188 W4829593 W4829600 W4829601 W4830163 W4830164 W4830431 W4830436 W4830889 W4832215 W4832216 W4832472 W4832943 W4832944 W4833370 W4833371 W4833766 W4834313 W4834721 W4834722 W4835143 W4835144 W4835498 W4835499 W4836369 W4836374 W4836646 W4837497 W4837498 W4837946 W4838472 W4838473 W4838626 W4839085 W4839450 W4839453 W4839874 W4839875 W4840352 W4840685 W4840686 W4841159 W4841160 W4841614 W4841615 W4841949 W4841950 W4842316 W4842706 W4842707 W4843112 W4843113 W4843519 W4843864 W4843866 W4844250 W4844645 W4845116 W4845117 W4845537 W4845544 W4845885 W4845888 W4846306 W4846307 W4846753 W4846756 W4847502 W4847503 W4847899 W4847900 W4848135 W4848136 W4848708 W4849066 W4849069 W4849592 W4849598 W4849973 W4849974 W4850216 W4850217 W4850218 W4850664 W4851089 W4851090 W4851258 W4851588 W4851593 W4851873 W4852280 W4852281 W4852282 W4852283 W4853103 W4853467 W4853945 W4853946 W4854364 W4854365 W4854697 W4854701 W4855273 W4855274 W4855699 W4855700 W4856113 W4856472 W4856473 W4856897 W4856898 W4857717 W4858447 W4858448 W4858868 W4859527 W4859528 W4859890 W4859893 W4860295 W4860304 W4861385 W4862166 W4868237 W4868644 W4869117 W4869118 W4880835 W4880836 W4881383 W4881384 W4881778 W4881779 W4882285 W4882286 W4882757 W4882758 W4883040 W4883041 W4884094 W4884095 W4884501 W4884502 W4884807 W4884808 W4885227 W4885228 W4885705 W4885706 W4886105 W4886106 W4886702 W4886703 W4887538 W4887539 W4887953 W4887954 W4888366 W4888367 W4888784 W4888785 W4888786 W4889638 W4889639 W4890188 W4890189 W4890569 W4890570 W4891020 W4891024 W4891931 W4891932 W4892418 W4892419 W4893069 W4893070 W4893677 W4894098 W4894099 W4894584 W4894585 W4895438 W4895439 W4895586 W4895587 W4896230 W4896231 W4896275 W4896909 W4896910 W4897703 W4897704 W4898148 W4898149 W4898429 W4898610 W4898611 W4898892 W4899094 W4899095 W4899902 W4899903 W4900220 W4900221 W4901083 W4901084 W4901474 W4901475 W4901476 W4901688 W4901689 W4901886 W4901887 W4902344 W4902596 W4902597 W4903038 W4903197 W4903198 W4903579 W4903580 W4903600 W4904335 W4904336 W4904513 W4904722 W4904723 W4905110 W4905113 W4905381 W4905569 W4905570 W4905854 W4905855 W4905968 W4905969 W4906479 W4906480 W4906954 W4906962 W4907364 W4907368 W4907925 W4907926 W4908231 W4908735 W4908744 W4909104 W4909105 W4909589 W4909590 W4909998 W4909999 W4910366 W4910768 W4910769 W4911041 W4911042 W4911535 W4911536 W4911942 W4911943 W4912065 W4912648 W4912649 W4912650 W4913181 W4913182 W4913183 W4913481 W4913482 W4913486 W4913882 W4913883 W4914208 W4914209 W4914210 W4914483 W4914487 W4914488 W4915015 W4915016 W4915017 W4915432 W4915433 W4915850 W4915854 W4916012 W4916016 W4916017 W4916393 W4916394 W4916703 W4916791 W4916797 W4916802 W4917195 W4917199 W4917557 W4917558 W4918093 W4918097 W4918103 W4918376 W4918377 W4918738 W4918739 W4919110 W4919111 W4919472 W4919473 W4920055 W4920056 W4920057 W4920484 W4920485 W4920733 W4920734 W4921133 W4921134 W4921518 W4921519 W4921994 W4921995 W4921996 W4922579 W4922580 W4923242 W4923243 W4923606 W4923607 W4924017 W4924018 W4924916 W4925731 W4925732 W4926097 W4926284 W4926285 W4926286 W4926287 W4926709 W4926710 W4927128 W4927543 W4927544 W4927552 W4928028 W4928044 W4928520 W4928523 W4928524 W4928887 W4928888 W4928889 W4929316 W4929703 W4929707 W4929994 W4930747 W4931227 W4931589 W4931590 W4931962 W4932125 W4932126 W4932127 W4932128 W4932732 W4932901 W4932902 W4933325 W4933326 W4934463 W4934880 W4934881 W4935293 W4935294 W4935702 W4935703 W4935704 W4935706 W4936087 W4936088 W4936089 W4936090 W4936424 W4936425 W4936426 W4936822 W4937246 W4937247 W4937627 W4937628 W4938241 W4938574 W4938575 W4938758 W4939527 W4940003 W4940004 W4940401 W4940420 W4941667 W4943582 W4943939 W4943940 W4944328 W4944336 W4944957 W4945437 W4945948 W4946183 W4946567 W4946569 W4946570 W4946955 W4947447 W4947448 W4947917 W4947920 W4948128 W4948580 W4948581 W4948964 W4949389 W4949710 W4949711 W4950035 W4950036 W4950872 W4950875 W4951236 W4951908 W4951910 W4951915 W4952301 W4952311 W4952748 W4952754 W4953157 W4953161 W4953162 W4953584 W4953925 W4954250 W4955041 W4955370 W4955972 W4956378 W4956379 W4956380 W4956382 W4956742 W4956743 W4956744 W4956747 W4956748 W4956970 W4956971 W4957330 W4957335 W4957707 W4957990 W4957998 W4957999 W4958492 W4958493 W4958494 W4958495 W4959327 W4959972 W4959973 W4960331 W4960333 W4960646 W4961574 W4961829 W4962825 W4963193 W4963194 W4963546 W4963547 W4964671 W4965028 W4965029 W4965664 W4965665 W4965666 W4966744 W4967021 W4967374 W4967731 W4968156 W4968157 W4968427 W4969895 W4970527 W4970528 W4970533 W4970535 W4971422 W4971423 W4971428 W4974436 W4974573 W4974580 W4974932 W4975277 W4975278 W4976223 W4976466 W4976809 W4976810 W4977137 W4977403 W4977404 W4977694 W4977695 W4977696 W4977698 W4978479 W4978480 W4978488 W4979923 W4979924 W4979927 W4980698 W4980699 W4980702 W4980703 W4981830 W4981831 W4982711 W4982714 W4982715 W4984135 W4984139 W4984147 W4984148 W4986043 W4986044 W4986045 W4986047 W4986048 W4986053 W4986054 W4986673 W4986678 W4988080 W4988081 W4988089 W4988090 W4988091 W4988095 W4988792 W4989799 W4989800 W4989802 W4989808 W4989814 W4990673 W4991945 W4991946 W4991949 W4992537 W4992544 W4992983 W4993411 W4993414 W4993576 W4993587 W4993588 W4994253 W4994323 W4994542 W4994609 W4994610 W4994945 W4995003 W4995257 W4997026 W4997034 W4997471 W4997820 W4998181 W4998549 W4998550 W4998883 W4999178 W4999180 W4999605 W4999974 W5000321 W5000322 W5003856 W5003857 W5004325 W5004329 W5004736 W5004739 W5005063 W5005064 W5005066 W5005556 W5005557 W5005827 W5005830 W5006093 W5006094 W5006299 W5006300 W5006594 W5006595 W5006596 W5006857 W5006864 W5007118 W5007159 W5007262 W5007592 W5007598 W5007878 W5007992 W5008394 W5008645 W5008763 W5009029 W5009031 W5009136 W5009146 W5009473 W5009884 W5009889 W5010559 W5010560 W5010879 W5010880 W5010883 W5010884 W5010885 W5011607 W5011608 W5014764 W5015172 W5015173 W5015505 W5015506 W5015754 W5015755 W5015756 W5015975 W5015976 W5016391 W5016392 W5016416 W5016757 W5016758 W5017196 W5017197 W5017503 W5017504 W5018382 W5018383 W5018769 W5018770 W5018771 W5019164 W5019165 W5019166 W5019167 W5019168 W5019169 W5019170 W5019171 W5019500 W5019501 W5019502 W5019503 W5019504 W5019505 W5019506 W5022581 W5022582 W5022583 W5022584 W5026298 W5026299 W5026731 W5026739 W5026740 W5027132 W5027489 W5027490 W5030057 W5030732 W5030736 W5030737 W5031207 W5031608 W5031610 W5031938 W5031939 W5032371 W5032372 W5032373 W5032374 W5032375 W5032381 W5033716 W5033956 W5033960 W5034455 W5034456 W5034813 W5035757 W5035758 W5036235 W5036236 W5037163 W5037164 W5037390 W5037392 W5037702 W5037703 W5038065 W5038074 W5038745 W5038749 W5038996 W5039491 W5039908 W5040269 W5040271 W5040586 W5040587 W5040609 W5040688 W5040689 W5041038 W5041454 W5041455 W5041780 W5041781 W5042220 W5042594 W5042595 W5042596 W5044169 W5044519 W5044527 W5044737 W5044738 W5045165 W5045166 W5045583 W5045594 W5046018 W5046019 W5046351  HEMO-10-EU Work Order Number: W4780014", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3177-2026%22", "url": "https://recallledger.net/recalls/device-z-3177-2026-brand-name-hemospray-endoscopic-hemostat-product-name-hemospray-end/"}, {"id": "fda-device-z-3176-2026", "source": "FDA", "category": "device", "recall_number": "Z-3176-2026", "title": "Happiest Baby recall (Happiest Baby, Inc)", "product": "Happiest Baby, Inc. SNOO Sleep Sack, X-Large  Model/Catalog Number: S2101-501\tS2101-508-11\tS2101-508-3\tS2101-508-4\tS2101-508-5\tS2101-508-6\tS2101-508-7\tS2101-512\tS2101-513\tS2101-532\tS2101-533\tS2101-534\tS2101-535\tS2101-536\tS2101-541\tS2101-551\tS2102-508-10\tS2102-508-9\tS2103-501\tS2103-502\tS2103-504\tS2103-508-11\tS2103-508-12\tS2103-508-13\tS2103-508-14\tS2103-508-6\tS2103-508-7\tS2103-508-8", "reason": "Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.", "hazard_level": "Class II", "company": "Happiest Baby, Inc", "company_location": "Los Angeles, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "14837", "codes": "All Lots/ No UDI", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3176-2026%22", "url": "https://recallledger.net/recalls/device-z-3176-2026-happiest-baby-inc-snoo-sleep-sack-x-large-model-catalog-number-s2/"}, {"id": "fda-device-z-3175-2026", "source": "FDA", "category": "device", "recall_number": "Z-3175-2026", "title": "Happiest Baby recall (Happiest Baby, Inc)", "product": "Happiest Baby, Inc SNOO Sleep Sack, X-Small   Model/Catalog Number: S2101-101\tS2101-108-6\tS2101-133\tS2102-112\tS2107-101\tS2107-110", "reason": "Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.", "hazard_level": "Class II", "company": "Happiest Baby, Inc", "company_location": "Los Angeles, CA, United States", "date": "2026-08-07", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "1055 units", "codes": "All Lots/UDI: None", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3175-2026%22", "url": "https://recallledger.net/recalls/device-z-3175-2026-happiest-baby-inc-snoo-sleep-sack-x-small-model-catalog-number-s2/"}, {"id": "fda-device-z-3174-2026", "source": "FDA", "category": "device", "recall_number": "Z-3174-2026", "title": "Brand Name: VERIQA recall (PTW FREIBURG)", "product": "Brand Name: VERIQA;  Product Name: RT MonteCarlo 3D v3;  Model/Catalog Number: S070031.520;  Software Version: 3.1.18;", "reason": "When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.", "hazard_level": "Class II", "company": "PTW FREIBURG", "company_location": "Freiburg Im Breisgau, N/A, Germany", "date": "2026-08-04", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of GA, NY and the countries of Austria, Belgium, Switzerland, Czechia, Germany, Spain, France, Netherlands, Norway, Poland, Portugal, Romania, T¿rkiye, Chile, United Arab Emirates, Saudi Arabia, Mexico, Hong Kong, Brazil, Tajikistan, Ecuador, Iran, Thailand, Serbia, South Africa, Kazakhstan, Algeria.", "states": ["GA", "NY"], "nationwide": true, "quantity": "2", "codes": "Model/Catalog Number: S070031.520; UDI-DI: +EPTWS070031Q5200; Software Version 3.1.18;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3174-2026%22", "url": "https://recallledger.net/recalls/device-z-3174-2026-brand-name-veriqa-product-name-rt-montecarlo-3d-v3-model-catalog/"}, {"id": "fda-device-z-3173-2026", "source": "FDA", "category": "device", "recall_number": "Z-3173-2026", "title": "GM Helix Implant recall (Straumann USA LLC)", "product": "GM Helix Implant, REF: 109.984;", "reason": "There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.", "hazard_level": "Class II", "company": "Straumann USA LLC", "company_location": "Andover, MA, United States", "date": "2026-08-12", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;", "states": ["AL", "AZ", "CA", "CO", "FL", "GA", "IL", "KS", "LA", "MA", "MI", "MO", "NC", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "TX", "VA", "WI"], "nationwide": true, "quantity": "216", "codes": "REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3173-2026%22", "url": "https://recallledger.net/recalls/device-z-3173-2026-gm-helix-implant-ref-109-984/"}, {"id": "fda-device-z-3165-2026", "source": "FDA", "category": "device", "recall_number": "Z-3165-2026", "title": "NOxBOXi Nitric Oxide Delivery System. recall (NOXBOX LTD)", "product": "NOxBOXi Nitric Oxide Delivery System.", "reason": "Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.", "hazard_level": "Class II", "company": "NOXBOX LTD", "company_location": "Sittingbourne, N/A, United Kingdom", "date": "2026-08-19", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of Georgia.", "states": ["GA"], "nationwide": true, "quantity": "1,547 units", "codes": "UDI-DI 05060541640009. Identification Number (Serial Number): NM100825 (NI100825), NM100833 (NI100833), NM100839 (NI100839), NM100840 (NI100840), NM100841 (NI100841), NM100847 (NI100847), NM100848 (NI100848), NM100849 (NI100849), NM100850 (NI100850), NM100851 (NI100851), NM100852 (NI100852), NM100855 (NI100855), NM100858 (NI100858), NM100859 (NI100859), NM100861 (NI100861), NM100862 (NI100862), NM100865 (NI100865), NM100866 (NI100866), NM100868 (NI100868), NM100869 (NI100869), NM100872 (NI100872), NM100873 (NI100873), NM100875 (NI100875), NM100876 (NI100876), NM100878 (NI100878), NM100879 (NI100879), NM100880 (NI100880), NM100881 (NI100881), NM100882 (NI100882), NM100883 (NI100883), NM100884 (NI100884), NM100885 (NI100885), NM100886 (NI100886), NM100887 (NI100887), NM100888 (NI100888), NM100895 (NI100895), NM100932 (NI100932), NM100935 (NI100935), NM100942 (NI100942), NM100948 (NI100948), NM100949 (NI100949), NM100953 (NI100953), NM100961 (NI100961), NM100975 (NI100975), NM100976 (NI100976), NM100978 (NI100978), NM100980 (NI100980), NM100983 (NI100983), NM100985 (NI100985), NM100986 (NI100986), NM100987 (NI100987), NM100989 (NI100989), NM100990 (NI100990), NM100991 (NI100991), NM100993 (NI100993), NM100994 (NI100994), NM100996 (NI100996), NM100997 (NI100997), NM100999 (NI100999), NM101001 (NI101001), NM101002 (NI101002), NM101003 (NI101003), NM101004 (NI101004), NM101005 (NI101005), NM101006 (NI101006), NM101008 (NI101008), NM101009 (NI101009), NM101010 (NI101010), NM101011 (NI101011), NM101012 (NI101012), NM101013 (NI101013), NM101014 (NI101014), NM101015 (NI101015), NM101017 (NI101017), NM101018 (NI101018), NM101019 (NI101019), NM101024 (NI101024), NM101026 (NI101026), NM101028 (NI101028), NM101029 (NI101029), NM101030 (NI101030), NM101031 (NI101031), NM101033 (NI101033), NM101034 (NI101034), NM101035 (NI101035), NM101038 (NI101038), NM101039 (NI101039), NM101041 (NI101041), NM101042 (NI101042), NM101044 (NI101044), NM101048 (NI101048), NM101049 (NI101049), NM101052 (NI101052), NM101057 (NI101057), NM101059 (NI101059), NM101060 (NI101060), NM101061 (NI101061), NM101063 (NI101063), NM101065 (NI101065), NM101067 (NI101067), NM101069 (NI101069), NM101071 (NI101071), NM101072 (NI101072), NM101073 (NI101073), NM101077 (NI101077), NM101079 (NI101079), NM101080 (NI101080), NM101081 (NI101081), NM101083 (NI101083), NM101084 (NI101084), NM101086 (NI101086), NM101088 (NI101088), NM101089 (NI101089), NM101090 (NI101090), NM101091 (NI101091), NM101092 (NI101092), NM101093 (NI101093), NM101094 (NI101094), NM101095 (NI101095), NM101099 (NI101099), NM101100 (NI101100), NM101101 (NI101101), NM101105 (NI101105), NM101106 (NI101106), NM101107 (NI101107), NM101108 (NI101108), NM101109 (NI101109), NM101110 (NI101110), NM101111 (NI101111), NM101112 (NI101112), NM101113 (NI101113), NM101114 (NI101114), NM101115 (NI101115), NM101116 (NI101116), NM101117 (NI101117), NM101125 (NI101125), NM101130 (NI101130), NM101131 (NI101131), NM101132 (NI101132), NM101133 (NI101133), NM101134 (NI101134), NM101135 (NI101135), NM101136 (NI101136), NM101137 (NI101137), NM101138 (NI101138), NM101141 (NI101141), NM101142 (NI101142), NM101144 (NI101144), NM101145 (NI101145), NM101146 (NI101146), NM101147 (NI101147), NM101148 (NI101148), NM101149 (NI101149), NM101150 (NI101150), NM101151 (NI101151), NM101153 (NI101153), NM101154 (NI101154), NM101155 (NI101155), NM101156 (NI101156), NM101158 (NI101158), NM101159 (NI101159), NM101160 (NI101160), NM101161 (NI101161), NM101162 (NI101162), NM101163 (NI101163), NM101164 (NI101164), NM101165 (NI101165), NM101167 (NI101167), NM101168 (NI101168), NM101170 (NI101170), NM101173 (NI101173), NM101174 (NI101174), NM101175 (NI101175), NM101176 (NI101176), NM101177 (NI101177), NM101178 (NI101178), NM101179 (NI101179), NM101180 (NI101180), NM101181 (NI101181), NM101182 (NI101182), NM101183 (NI101183), NM101184 (NI101184), NM101190 (NI101190), NM101191 (NI101191), NM101192 (NI101192), NM101199 (NI101199), NM101202 (NI101202), NM101204 (NI101204), NM101205 (NI101205), NM101207 (NI101207), NM101208 (NI101208), NM101209 (NI101209), NM101211 (NI101211), NM101212 (NI101212), NM101213 (NI101213), NM101214 (NI101214), NM101215 (NI101215), NM101216 (NI101216), NM101217 (NI101217), NM101218 (NI101218), NM101219 (NI101219), NM101220 (NI101220), NM101221 (NI101221), NM101222 (NI101222), NM101223 (NI101223), NM101224 (NI101224), NM101225 (NI101225), NM101227 (NI101227), NM101228 (NI101228), NM101229 (NI101229), NM101230 (NI101230), NM101231 (NI101231), NM101232 (NI101232), NM101233 (NI101233), NM101234 (NI101234), NM101236 (NI101236), NM101237 (NI101237), NM101241 (NI101241), NM101243 (NI101243), NM101244 (NI101244), NM101245 (NI101245), NM101246 (NI101246), NM101249 (NI101249), NM101250 (NI101250), NM101251 (NI101251), NM101252 (NI101252), NM101253 (NI101253), NM101254 (NI101254), NM101255 (NI101255), NM101256 (NI101256), NM101257 (NI101257), NM101258 (NI101258), NM101259 (NI101259), NM101263 (NI101263), NM101264 (NI101264), NM101265 (NI101265), NM101266 (NI101266), NM101268 (NI101268), NM101270 (NI101270), NM101271 (NI101271), NM101273 (NI101273), NM101278 (NI101278), NM101282 (NI101282), NM101284 (NI101284), NM101285 (NI101285), NM101286 (NI101286), NM101287 (NI101287), NM101288 (NI101288), NM101289 (NI101289), NM101292 (NI101292), NM101294 (NI101294), NM101295 (NI101295), NM101297 (NI101297), NM101298 (NI101298), NM101299 (NI101299), NM101300 (NI101300), NM101301 (NI101301), NM101303 (NI101303), NM101305 (NI101305), NM101307 (NI101307), NM101308 (NI101308), NM101309 (NI101309), NM101313 (NI101313), NM101314 (NI101314), NM101317 (NI101317), NM101321 (NI101321), NM101322 (NI101322), NM101323 (NI101323), NM101324 (NI101324), NM101326 (NI101326), NM101327 (NI101327), NM101328 (NI101328), NM101329 (NI101329), NM101330 (NI101330), NM101331 (NI101331), NM101333 (NI101333), NM101335 (NI101335), NM101336 (NI101336), NM101337 (NI101337), NM101338 (NI101338), NM101340 (NI101340), NM101342 (NI101342), NM101344 (NI101344), NM101346 (NI101346), NM101347 (NI101347), NM101349 (NI101349), NM101350 (NI101350), NM101351 (NI101351), NM101353 (NI101353), NM101354 (NI101354), NM101355 (NI101355), NM101356 (NI101356), NM101357 (NI101357), NM101359 (NI101359), NM101360 (NI101360), NM101361 (NI101361), NM101368 (NI101368), NM101372 (NI101372), NM101373 (NI101373), NM101376 (NI101376), NM101377 (NI101377), NM101379 (NI101379), NM101380 (NI101380), NM101381 (NI101381), NM101384 (NI101384), NM101386 (NI101386), NM101387 (NI101387), NM101388 (NI101388), NM101390 (NI101390), NM101392 (NI101392), NM101393 (NI101393), NM101394 (NI101394), NM101395 (NI101395), NM101396 (NI101396), NM101402 (NI101402), NM101404 (NI101404), NM101405 (NI101405), NM101406 (NI101406), NM101407 (NI101407), NM101408 (NI101408), NM101409 (NI101409), NM101410 (NI101410), NM101411 (NI101411), NM101412 (NI101412), NM101413 (NI101413), NM101414 (NI101414), NM101415 (NI101415), NM101416 (NI101416), NM101423 (NI101423), NM101425 (NI101425), NM101426 (NI101426), NM101428 (NI101428), NM101429 (NI101429), NM101430 (NI101430), NM101431 (NI101431), NM101432 (NI101432), NM101433 (NI101433), NM101434 (NI101434), NM101435 (NI101435), NM101436 (NI101436), NM101437 (NI101437), NM101439 (NI101439), NM101441 (NI101441), NM101442 (NI101442), NM101443 (NI101443), NM101444 (NI101444), NM101446 (NI101446), NM101448 (NI101448), NM101449 (NI101449), NM101451 (NI101451), NM101452 (NI101452), NM101454 (NI101454), NM101456 (NI101456), NM101457 (NI101457), NM101459 (NI101459), NM101460 (NI101460), NM101461 (NI101461), NM101462 (NI101462), NM101463 (NI101463), NM101464 (NI101464), NM101467 (NI101467), NM101468 (NI101468), NM101469 (NI101469), NM101472 (NI101472), NM101473 (NI101473), NM101474 (NI101474), NM101475 (NI101475), NM101478 (NI101478), NM101479 (NI101479), NM101482 (NI101482), NM101483 (NI101483), NM101484 (NI101484), NM101485 (NI101485), NM101486 (NI101486), NM101487 (NI101487), NM101489 (NI101489), NM101490 (NI101490), NM101491 (NI101491), NM101492 (NI101492), NM101496 (NI101496), NM101505 (NI101505), NM101506 (NI101506), NM101508 (NI101508), NM101509 (NI101509), NM101512 (NI101512), NM101514 (NI101514), NM101515 (NI101515), NM101516 (NI101516), NM101520 (NI101520), NM101521 (NI101521), NM101522 (NI101522), NM101524 (NI101524), NM101525 (NI101525), NM101526 (NI101526), NM101527 (NI101527), NM101529 (NI101529), NM101530 (NI101530), NM101532 (NI101532), NM101533 (NI101533), NM101540 (NI101540), NM101550 (NI101550), NM101551 (NI101551), NM101552 (NI101552), NM101553 (NI101553), NM101554 (NI101554), NM101557 (NI101557), NM101560 (NI101560), NM101563 (NI101563), NM101565 (NI101565), NM101566 (NI101566), NM101569 (NI101569), NM101570 (NI101570), NM101572 (NI101572), NM101573 (NI101573), NM101574 (NI101574), NM101575 (NI101575), NM101576 (NI101576), NM101577 (NI101577), NM101578 (NI101578), NM101579 (NI101579), NM101581 (NI101581), NM101584 (NI101584), NM101585 (NI101585), NM101588 (NI101588), NM101590 (NI101590), NM101591 (NI101591), NM101592 (NI101592), NM101593 (NI101593), NM101594 (NI101594), NM101595 (NI101595), NM101596 (NI101596), NM101597 (NI101597), NM101598 (NI101598), NM101599 (NI101599), NM101600 (NI101600), NM101601 (NI101601), NM101602 (NI101602), NM101604 (NI101604), NM101605 (NI101605), NM101606 (NI101606), NM101607 (NI101607), NM101608 (NI101608), NM101609 (NI101609), NM101610 (NI101610), NM101611 (NI101611), NM101612 (NI101612), NM101613 (NI101613), NM101614 (NI101614), NM101615 (NI101615), NM101616 (NI101616), NM101617 (NI101617), NM101620 (NI101620), NM101622 (NI101622), NM101623 (NI101623), NM101624 (NI101624), NM101625 (NI101625), NM101626 (NI101626), NM101627 (NI101627), NM101628 (NI101628), NM101629 (NI101629), NM101635 (NI101635), NM101636 (NI101636), NM101638 (NI101638), NM101639 (NI101639), NM101640 (NI101640), NM101641 (NI101641), NM101643 (NI101643), NM101644 (NI101644), NM101645 (NI101645), NM101651 (NI101651), NM101654 (NI101654), NM101655 (NI101655), NM101656 (NI101656), NM101657 (NI101657), NM101658 (NI101658), NM101659 (NI101659), NM101660 (NI101660), NM101662 (NI101662), NM101664 (NI101664), NM101665 (NI101665), NM101666 (NI101666), NM101667 (NI101667), NM101668 (NI101668), NM101669 (NI101669), NM101670 (NI101670), NM101671 (NI101671), NM101672 (NI101672), NM101674 (NI101674), NM101675 (NI101675), NM101676 (NI101676), NM101677 (NI101677), NM101678 (NI101678), NM101679 (NI101679), NM101680 (NI101680), NM101681 (NI101681), NM101682 (NI101682), NM101683 (NI101683), NM101684 (NI101684), NM101685 (NI101685), NM101686 (NI101686), NM101687 (NI101687), NM101688 (NI101688), NM101689 (NI101689), NM101690 (NI101690), NM101691 (NI101691), NM101692 (NI101692), NM101693 (NI101693), NM101694 (NI101694), NM101695 (NI101695), NM101696 (NI101696), NM101697 (NI101697), NM101699 (NI101699), NM101700 (NI101700), NM101703 (NI101703), NM101704 (NI101704), NM101705 (NI101705), NM101706 (NI101706), NM101707 (NI101707), NM101708 (NI101708), NM101709 (NI101709), NM101710 (NI101710), NM101711 (NI101711), NM101712 (NI101712), NM101713 (NI101713), NM101714 (NI101714), NM101715 (NI101715), NM101716 (NI101716), NM101717 (NI101717), NM101718 (NI101718), NM101719 (NI101719), NM101720 (NI101720), NM101721 (NI101721), NM101722 (NI101722), NM101723 (NI101723), NM101724 (NI101724), NM101726 (NI101726), NM101727 (NI101727), NM101729 (NI101729), NM101731 (NI101731), NM101732 (NI101732), NM101733 (NI101733), NM101735 (NI101735), NM101736 (NI101736), NM101737 (NI101737), NM101739 (NI101739), NM101740 (NI101740), NM101742 (NI101742), NM101743 (NI101743), NM101744 (NI101744), NM101746 (NI101746), NM101747 (NI101747), NM101748 (NI101748), NM101749 (NI101749), NM101750 (NI101750), NM101751 (NI101751), NM101753 (NI101753), NM101756 (NI101756), NM101759 (NI101759), NM101760 (NI101760), NM101761 (NI101761), NM101763 (NI101763), NM101765 (NI101765), NM101766 (NI101766), NM101767 (NI101767), NM101768 (NI101768), NM101769 (NI101769), NM101770 (NI101770), NM101771 (NI101771), NM101775 (NI101775), NM101776 (NI101776), NM101777 (NI101777), NM101778 (NI101778), NM101781 (NI101781), NM101782 (NI101782), NM101783 (NI101783), NM101784 (NI101784), NM101787 (NI101787), NM101791 (NI101791), NM101793 (NI101793), NM101794 (NI101794), NM101795 (NI101795), NM101796 (NI101796), NM101797 (NI101797), NM101798 (NI101798), NM101799 (NI101799), NM101804 (NI101804), NM101805 (NI101805), NM101806 (NI101806), NM101807 (NI101807), NM101808 (NI101808), NM101809 (NI101809), NM101810 (NI101810), NM101811 (NI101811), NM101812 (NI101812), NM101813 (NI101813), NM101814 (NI101814), NM101815 (NI101815), NM101816 (NI101816), NM101817 (NI101817), NM101818 (NI101818), NM101819 (NI101819), NM101820 (NI101820), NM101821 (NI101821), NM101822 (NI101822), NM101823 (NI101823), NM101824 (NI101824), NM101825 (NI101825), NM101826 (NI101826), NM101828 (NI101828), NM101829 (NI101829), NM101831 (NI101831), NM101832 (NI101832), NM101834 (NI101834), NM101835 (NI101835), NM101836 (NI101836), NM101837 (NI101837), NM101838 (NI101838), NM101840 (NI101840), NM101841 (NI101841), NM101842 (NI101842), NM101843 (NI101843), NM101844 (NI101844), NM101845 (NI101845), NM101846 (NI101846), NM101848 (NI101848), NM101849 (NI101849), NM101851 (NI101851), NM101854 (NI101854), NM101857 (NI101857), NM101859 (NI101859), NM101861 (NI101861), NM101862 (NI101862), NM101864 (NI101864), NM101865 (NI101865), NM101867 (NI101867), NM101868 (NI101868), NM101869 (NI101869), NM101872 (NI101872), NM101873 (NI101873), NM101874 (NI101874), NM101875 (NI101875), NM101876 (NI101876), NM101878 (NI101878), NM101879 (NI101879), NM101880 (NI101880), NM101881 (NI101881), NM101882 (NI101882), NM101883 (NI101883), NM101884 (NI101884), NM101885 (NI101885), NM101886 (NI101886), NM101887 (NI101887), NM101889 (NI101889), NM101890 (NI101890), NM101891 (NI101891), NM101892 (NI101892), NM101895 (NI101895), NM101896 (NI101896), NM101898 (NI101898), NM101899 (NI101899), NM101901 (NI101901), NM101902 (NI101902), NM101903 (NI101903), NM101904 (NI101904), NM101905 (NI101905), NM101906 (NI101906), NM101907 (NI101907), NM101908 (NI101908), NM101909 (NI101909), NM101910 (NI101910), NM101912 (NI101912), NM101913 (NI101913), NM101914 (NI101914), NM101916 (NI101916), NM101919 (NI101919), NM101920 (NI101920), NM101922 (NI101922), NM101924 (NI101924), NM101925 (NI101925), NM101926 (NI101926), NM101928 (NI101928), NM101936 (NI101936), NM101937 (NI101937), NM101939 (NI101939), NM101940 (NI101940), NM101941 (NI101941), NM101942 (NI101942), NM101943 (NI101943), NM101944 (NI101944), NM101945 (NI101945), NM101946 (NI101946), NM101947 (NI101947), NM101948 (NI101948), NM101952 (NI101952), NM101953 (NI101953), NM101954 (NI101954), NM101955 (NI101955), NM101956 (NI101956), NM101957 (NI101957), NM101958 (NI101958), NM101959 (NI101959), NM101960 (NI101960), NM101961 (NI101961), NM101962 (NI101962), NM101963 (NI101963), NM101964 (NI101964), NM101965 (NI101965), NM101966 (NI101966), NM101967 (NI101967), NM101968 (NI101968), NM101970 (NI101970), NM101971 (NI101971), NM101972 (NI101972), NM101973 (NI101973), NM101974 (NI101974), NM101975 (NI101975), NM101976 (NI101976), NM101977 (NI101977), NM101978 (NI101978), NM101979 (NI101979), NM101981 (NI101981), NM101982 (NI101982), NM101983 (NI101983), NM101984 (NI101984), NM101985 (NI101985), NM101986 (NI101986), NM101987 (NI101987), NM101988 (NI101988), NM101989 (NI101989), NM101990 (NI101990), NM101991 (NI101991), NM101992 (NI101992), NM101993 (NI101993), NM101994 (NI101994), NM101995 (NI101995), NM101996 (NI101996), NM101997 (NI101997), NM101998 (NI101998), NM101999 (NI101999), NM102000 (NI102000), NM102001 (NI102001), NM102002 (NI102002), NM102003 (NI102003), NM102004 (NI102004), NM102006 (NI102006), NM102007 (NI102007), NM102008 (NI102008), NM102009 (NI102009), NM102010 (NI102010), NM102011 (NI102011), NM102012 (NI102012), NM102013 (NI102013), NM102014 (NI102014), NM102015 (NI102015), NM102017 (NI102017), NM102018 (NI102018), NM102019 (NI102019), NM102020 (NI102020), NM102021 (NI102021), NM102023 (NI102023), NM102024 (NI102024), NM102025 (NI102025), NM102026 (NI102026), NM102027 (NI102027), NM102028 (NI102028), NM102031 (NI102031), NM102032 (NI102032), NM102033 (NI102033), NM102035 (NI102035), NM102036 (NI102036), NM102037 (NI102037), NM102038 (NI102038), NM102040 (NI102040), NM102043 (NI102043), NM102044 (NI102044), NM102045 (NI102045), NM102046 (NI102046), NM102047 (NI102047), NM102048 (NI102048), NM102049 (NI102049), NM102051 (NI102051), NM102052 (NI102052), NM102053 (NI102053), NM102055 (NI102055), NM102056 (NI102056), NM102057 (NI102057), NM102059 (NI102059), NM102060 (NI102060), NM102061 (NI102061), NM102062 (NI102062), NM102063 (NI102063), NM102065 (NI102065), NM102067 (NI102067), NM102068 (NI102068), NM102069 (NI102069), NM102070 (NI102070), NM102071 (NI102071), NM102072 (NI102072), NM102074 (NI102074), NM102075 (NI102075), NM102076 (NI102076), NM102077 (NI102077), NM102078 (NI102078), NM102079 (NI102079), NM102081 (NI102081), NM102082 (NI102082), NM102083 (NI102083), NM102086 (NI102086), NM102089 (NI102089), NM102090 (NI102090), NM102091 (NI102091), NM102092 (NI102092), NM102093 (NI102093), NM102094 (NI102094), NM102095 (NI102095), NM102096 (NI102096), NM102097 (NI102097), NM102098 (NI102098), NM102099 (NI102099), NM102102 (NI102102), NM102103 (NI102103), NM102104 (NI102104), NM102105 (NI102105), NM102106 (NI102106), NM102107 (NI102107), NM102108 (NI102108), NM102109 (NI102109), NM102110 (NI102110), NM102111 (NI102111), NM102113 (NI102113), NM102114 (NI102114), NM102115 (NI102115), NM102116 (NI102116), NM102117 (NI102117), NM102118 (NI102118), NM102119 (NI102119), NM102120 (NI102120), NM102121 (NI102121), NM102123 (NI102123), NM102124 (NI102124), NM102125 (NI102125), NM102126 (NI102126), NM102127 (NI102127), NM102128 (NI102128), NM102129 (NI102129), NM102131 (NI102131), NM102132 (NI102132), NM102133 (NI102133), NM102134 (NI102134), NM102135 (NI102135), NM102136 (NI102136), NM102137 (NI102137), NM102138 (NI102138), NM102139 (NI102139), NM102140 (NI102140), NM102141 (NI102141), NM102142 (NI102142), NM102144 (NI102144), NM102145 (NI102145), NM102146 (NI102146), NM102147 (NI102147), NM102148 (NI102148), NM102149 (NI102149), NM102150 (NI102150), NM102152 (NI102152), NM102155 (NI102155), NM102160 (NI102160), NM102161 (NI102161), NM102163 (NI102163), NM102164 (NI102164), NM102165 (NI102165), NM102166 (NI102166), NM102167 (NI102167), NM102168 (NI102168), NM102169 (NI102169), NM102170 (NI102170), NM102171 (NI102171), NM102172 (NI102172), NM102173 (NI102173), NM102174 (NI102174), NM102175 (NI102175), NM102176 (NI102176), NM102177 (NI102177), NM102180 (NI102180), NM102182 (NI102182), NM102183 (NI102183), NM102184 (NI102184), NM102186 (NI102186), NM102188 (NI102188), NM102189 (NI102189), NM102190 (NI102190), NM102191 (NI102191), NM102192 (NI102192), NM102193 (NI102193), NM102194 (NI102194), NM102195 (NI102195), NM102196 (NI102196), NM102197 (NI102197), NM102198 (NI102198), NM102199 (NI102199), NM102200 (NI102200), NM102205 (NI102205), NM102206 (NI102206), NM102208 (NI102208), NM102209 (NI102209), NM102212 (NI102212), NM102213 (NI102213), NM102214 (NI102214), NM102215 (NI102215), NM102216 (NI102216), NM102219 (NI102219), NM102221 (NI102221), NM102222 (NI102222), NM102226 (NI102226), NM102227 (NI102227), NM102228 (NI102228), NM102230 (NI102230), NM102231 (NI102231), NM102232 (NI102232), NM102233 (NI102233), NM102234 (NI102234), NM102235 (NI102235), NM102237 (NI102237), NM102238 (NI102238), NM102239 (NI102239), NM102240 (NI102240), NM102241 (NI102241), NM102244 (NI102244), NM102245 (NI102245), NM102246 (NI102246), NM102247 (NI102247), NM102249 (NI102249), NM102250 (NI102250), NM102253 (NI102253), NM102254 (NI102254), NM102255 (NI102255), NM102256 (NI102256), NM102259 (NI102259), NM102263 (NI102263), NM102265 (NI102265), NM102266 (NI102266), NM102268 (NI102268), NM102269 (NI102269), NM102270 (NI102270), NM102271 (NI102271), NM102272 (NI102272), NM102273 (NI102273), NM102274 (NI102274), NM102275 (NI102275), NM102276 (NI102276), NM102277 (NI102277), NM102278 (NI102278), NM102279 (NI102279), NM102280 (NI102280), NM102281 (NI102281), NM102282 (NI102282), NM102283 (NI102283), NM102284 (NI102284), NM102285 (NI102285), NM102286 (NI102286), NM102287 (NI102287), NM102288 (NI102288), NM102290 (NI102290), NM102291 (NI102291), NM102292 (NI102292), NM102293 (NI102293), NM102295 (NI102295), NM102296 (NI102296), NM102297 (NI102297), NM102298 (NI102298), NM102299 (NI102299), NM102300 (NI102300), NM102304 (NI102304), NM102305 (NI102305), NM102306 (NI102306), NM102307 (NI102307), NM102308 (NI102308), NM102309 (NI102309), NM102310 (NI102310), NM102311 (NI102311), NM102327 (NI102327), NM102329 (NI102329), NM102330 (NI102330), NM102331 (NI102331), NM102332 (NI102332), NM102338 (NI102338), NM102339 (NI102339), NM102340 (NI102340), NM102341 (NI102341), NM102342 (NI102342), NM102343 (NI102343), NM102345 (NI102345), NM102346 (NI102346), NM102347 (NI102347), NM102349 (NI102349), NM102350 (NI102350), NM102351 (NI102351), NM102355 (NI102355), NM102356 (NI102356), NM102357 (NI102357), NM102358 (NI102358), NM102359 (NI102359), NM102360 (NI102360), NM102361 (NI102361), NM102362 (NI102362), NM102363 (NI102363), NM102364 (NI102364), NM102366 (NI102366), NM102377 (NI102377), NM102380 (NI102380), NM102381 (NI102381), NM102383 (NI102383), NM102384 (NI102384), NM102385 (NI102385), NM102387 (NI102387), NM102389 (NI102389), NM102390 (NI102390), NM102391 (NI102391), NM102392 (NI102392), NM102393 (NI102393), NM102394 (NI102394), NM102395 (NI102395), NM102396 (NI102396), NM102397 (NI102397), NM102398 (NI102398), NM102399 (NI102399), NM102400 (NI102400), NM102402 (NI102402), NM102403 (NI102403), NM102404 (NI102404), NM102405 (NI102405), NM102406 (NI102406), NM102407 (NI102407), NM102408 (NI102408), NM102410 (NI102410), NM102411 (NI102411), NM102413 (NI102413), NM102414 (NI102414), NM102415 (NI102415), NM102417 (NI102417), NM102418 (NI102418), NM102422 (NI102422), NM102423 (NI102423), NM102424 (NI102424), NM102425 (NI102425), NM102426 (NI102426), NM102427 (NI102427), NM102428 (NI102428), NM102429 (NI102429), NM102431 (NI102431), NM102432 (NI102432), NM102433 (NI102433), NM102434 (NI102434), NM102435 (NI102435), NM102436 (NI102436), NM102437 (NI102437), NM102438 (NI102438), NM102444 (NI102444), NM102445 (NI102445), NM102447 (NI102447), NM102463 (NI102463), NM102466 (NI102466), NM102467 (NI102467), NM102472 (NI102472), NM102473 (NI102473), NM102474 (NI102474), NM102475 (NI102475), NM102476 (NI102476), NM102477 (NI102477), NM102478 (NI102478), NM102479 (NI102479), NM102480 (NI102480), NM102481 (NI102481), NM102482 (NI102482), NM102483 (NI102483), NM102484 (NI102484), NM102485 (NI102485), NM102486 (NI102486), NM102487 (NI102487), NM102488 (NI102488), NM102489 (NI102489), NM102490 (NI102490), NM102492 (NI102492), NM102494 (NI102494), NM102495 (NI102495), NM102496 (NI102496), NM102497 (NI102497), NM102498 (NI102498), NM102499 (NI102499), NM102500 (NI102500), NM102501 (NI102501), NM102502 (NI102502), NM102503 (NI102503), NM102504 (NI102504), NM102506 (NI102506), NM102507 (NI102507), NM102509 (NI102509), NM102510 (NI102510), NM102511 (NI102511), NM102512 (NI102512), NM102513 (NI102513), NM102517 (NI102517), NM102518 (NI102518), NM102519 (NI102519), NM102520 (NI102520), NM102522 (NI102522), NM102525 (NI102525), NM102528 (NI102528), NM102530 (NI102530), NM102531 (NI102531), NM102535 (NI102535), NM102536 (NI102536), NM102537 (NI102537), NM102538 (NI102538), NM102539 (NI102539), NM102540 (NI102540), NM102541 (NI102541), NM102542 (NI102542), NM102543 (NI102543), NM102544 (NI102544), NM102545 (NI102545), NM102546 (NI102546), NM102547 (NI102547), NM102548 (NI102548), NM102550 (NI102550), NM102551 (NI102551), NM102552 (NI102552), NM102553 (NI102553), NM102554 (NI102554), NM102555 (NI102555), NM102556 (NI102556), NM102557 (NI102557), NM102558 (NI102558), NM102560 (NI102560), NM102561 (NI102561), NM102562 (NI102562), NM102563 (NI102563), NM102564 (NI102564), NM102565 (NI102565), NM102566 (NI102566), NM102567 (NI102567), NM102568 (NI102568), NM102569 (NI102569), NM102570 (NI102570), NM102571 (NI102571), NM102574 (NI102574), NM102575 (NI102575), NM102576 (NI102576), NM102577 (NI102577), NM102578 (NI102578), NM102579 (NI102579), NM102580 (NI102580), NM102581 (NI102581), NM102582 (NI102582), NM102583 (NI102583), NM102584 (NI102584), NM102585 (NI102585), NM102586 (NI102586), NM102587 (NI102587), NM102588 (NI102588), NM102590 (NI102590), NM102591 (NI102591), NM102592 (NI102592), NM102593 (NI102593), NM102594 (NI102594), NM102595 (NI102595), NM102596 (NI102596), NM102597 (NI102597), NM102598 (NI102598), NM102599 (NI102599), NM102600 (NI102600), NM102601 (NI102601), NM102602 (NI102602), NM102604 (NI102604), NM102605 (NI102605), NM102606 (NI102606), NM102607 (NI102607), NM102608 (NI102608), NM102610 (NI102610), NM102611 (NI102611), NM102613 (NI102613), NM102614 (NI102614), NM102615 (NI102615), NM102616 (NI102616), NM102617 (NI102617), NM102618 (NI102618), NM102619 (NI102619), NM102620 (NI102620), NM102621 (NI102621), NM102622 (NI102622), NM102623 (NI102623), NM102624 (NI102624), NM102625 (NI102625), NM102627 (NI102627), NM102628 (NI102628), NM102629 (NI102629), NM102630 (NI102630), NM102631 (NI102631), NM102632 (NI102632), NM102634 (NI102634), NM102635 (NI102635), NM102637 (NI102637), NM102638 (NI102638), NM102639 (NI102639), NM102640 (NI102640), NM102641 (NI102641), NM102642 (NI102642), NM102643 (NI102643), NM102645 (NI102645), NM102647 (NI102647), NM102648 (NI102648), NM102649 (NI102649), NM102651 (NI102651), NM102652 (NI102652), NM102653 (NI102653), NM102655 (NI102655), NM102656 (NI102656), NM102657 (NI102657), NM102658 (NI102658), NM102659 (NI102659), NM102660 (NI102660), NM102661 (NI102661), NM102662 (NI102662), NM102663 (NI102663), NM102664 (NI102664), NM102665 (NI102665), NM102666 (NI102666), NM102667 (NI102667), NM102668 (NI102668), NM102669 (NI102669), NM102670 (NI102670), NM102671 (NI102671), NM102672 (NI102672), NM102673 (NI102673), NM102674 (NI102674), NM102675 (NI102675), NM102676 (NI102676), NM102680 (NI102680), NM102681 (NI102681), NM102683 (NI102683), NM102684 (NI102684), NM102685 (NI102685), NM102686 (NI102686), NM102687 (NI102687), NM102688 (NI102688), NM102689 (NI102689), NM102691 (NI102691), NM102692 (NI102692), NM102693 (NI102693), NM102695 (NI102695), NM102696 (NI102696), NM102697 (NI102697), NM102698 (NI102698), NM102699 (NI102699), NM102700 (NI102700), NM102701 (NI102701), NM102702 (NI102702), NM102703 (NI102703), NM102704 (NI102704), NM102705 (NI102705), NM102706 (NI102706), NM102707 (NI102707), NM102708 (NI102708), NM102709 (NI102709), NM102710 (NI102710), NM102711 (NI102711), NM102713 (NI102713), NM102714 (NI102714), NM102715 (NI102715), NM102717 (NI102717), NM102720 (NI102720), NM102722 (NI102722), NM102724 (NI102724), NM102725 (NI102725), NM102726 (NI102726), NM102727 (NI102727), NM102728 (NI102728), NM102729 (NI102729), NM102730 (NI102730), NM102731 (NI102731), NM102732 (NI102732), NM102733 (NI102733), NM102734 (NI102734), NM102735 (NI102735), NM102736 (NI102736), NM102737 (NI102737), NM102738 (NI102738), NM102739 (NI102739), NM102740 (NI102740), NM102741 (NI102741), NM102742 (NI102742), NM102743 (NI102743), NM102744 (NI102744), NM102745 (NI102745), NM102746 (NI102746), NM102747 (NI102747), NM102748 (NI102748), NM102751 (NI102751), NM102752 (NI102752), NM102753 (NI102753), NM102755 (NI102755), NM102756 (NI102756), NM102757 (NI102757), NM102758 (NI102758), NM102759 (NI102759), NM102760 (NI102760), NM102762 (NI102762), NM102763 (NI102763), NM102764 (NI102764), NM102765 (NI102765), NM102766 (NI102766), NM102767 (NI102767), NM102768 (NI102768), NM102769 (NI102769), NM102770 (NI102770), NM102771 (NI102771), NM102772 (NI102772), NM102773 (NI102773), NM102774 (NI102774), NM102776 (NI102776), NM102777 (NI102777), NM102778 (NI102778), NM102781 (NI102781), NM102783 (NI102783), NM102784 (NI102784), NM102785 (NI102785), NM102786 (NI102786), NM102789 (NI102789), NM102790 (NI102790), NM102791 (NI102791), NM102792 (NI102792), NM102793 (NI102793), NM102794 (NI102794), NM102795 (NI102795), NM102798 (NI102798), NM102799 (NI102799), NM102800 (NI102800), NM102801 (NI102801), NM102802 (NI102802), NM102803 (NI102803), NM102804 (NI102804), NM102805 (NI102805), NM102806 (NI102806), NM102807 (NI102807), NM102808 (NI102808), NM102809 (NI102809), NM102810 (NI102810), NM102811 (NI102811), NM102812 (NI102812), NM102813 (NI102813), NM102814 (NI102814), NM102815 (NI102815), NM102816 (NI102816), NM102817 (NI102817), NM102818 (NI102818), NM102819 (NI102819), NM102821 (NI102821), NM102823 (NI102823), NM102824 (NI102824), NM102825 (NI102825), NM102828 (NI102828), NM102830 (NI102830), NM102832 (NI102832), NM102833 (NI102833), NM102834 (NI102834), NM102836 (NI102836), NM102837 (NI102837), NM102838 (NI102838), NM102839 (NI102839), NM102840 (NI102840), NM102841 (NI102841), NM102842 (NI102842), NM102843 (NI102843), NM102844 (NI102844), NM102845 (NI102845), NM102846 (NI102846), NM102847 (NI102847), NM102848 (NI102848), NM102849 (NI102849), NM102850 (NI102850), NM102851 (NI102851), NM102852 (NI102852), NM102853 (NI102853), NM102854 (NI102854), NM102855 (NI102855), NM102856 (NI102856), NM102858 (NI102858), NM102859 (NI102859), NM102860 (NI102860), NM102861 (NI102861), NM102862 (NI102862), NM102863 (NI102863), NM102865 (NI102865), NM102866 (NI102866), NM102868 (NI102868), NM102870 (NI102870), NM102871 (NI102871), NM102872 (NI102872), NM102873 (NI102873), NM102874 (NI102874), NM102876 (NI102876), NM102877 (NI102877), NM102878 (NI102878), NM102879 (NI102879), NM102880 (NI102880), NM102881 (NI102881), NM102882 (NI102882), NM102883 (NI102883), NM102884 (NI102884), NM102885 (NI102885), NM102886 (NI102886), NM102887 (NI102887), NM102888 (NI102888), NM102889 (NI102889), NM102890 (NI102890), NM102891 (NI102891), NM102892 (NI102892), NM102893 (NI102893), NM102894 (NI102894), NM102897 (NI102897), NM102898 (NI102898), NM102899 (NI102899), NM102900 (NI102900), NM102901 (NI102901), NM102902 (NI102902), NM102904 (NI102904), NM102905 (NI102905), NM102906 (NI102906), NM102907 (NI102907), NM102908 (NI102908), NM102910 (NI102910), NM102911 (NI102911), NM102913 (NI102913), NM102914 (NI102914), NM102915 (NI102915), NM102916 (NI102916), NM102917 (NI102917), NM102918 (NI102918), NM102919 (NI102919), NM102920 (NI102920), NM102921 (NI102921), NM102922 (NI102922), NM102923 (NI102923), NM102926 (NI102926), NM102927 (NI102927), NM102928 (NI102928), NM102929 (NI102929), NM102930 (NI102930), NM102931 (NI102931), NM102932 (NI102932), NM102933 (NI102933), NM102934 (NI102934), NM102935 (NI102935), NM102936 (NI102936), NM102937 (NI102937), NM102939 (NI102939), NM102942 (NI102942), NM102944 (NI102944), NM102947 (NI102947), NM102950 (NI102950), NM102955 (NI102955), NM102957 (NI102957), NM102958 (NI102958), NM102961 (NI102961), NM102962 (NI102962), NM102963 (NI102963), NM102964 (NI102964), NM102966 (NI102966), NM102967 (NI102967), NM102968 (NI102968), NM102970 (NI102970), NM102973 (NI102973), NM102977 (NI102977), NM102979 (NI102979), NM102986 (NI102986), NM102987 (NI102987), NM102989 (NI102989), NM102990 (NI102990), NM102991 (NI102991), NM102992 (NI102992), NM102996 (NI102996), NM102997 (NI102997), NM102998 (NI102998), NM102999 (NI102999), NM103001 (NI103001), NM103002 (NI103002), NM103003 (NI103003), NM103007 (NI103007), NM103011 (NI103011), NM103012 (NI103012), NM103014 (NI103014), NM103016 (NI103016), NM103017 (NI103017), NM103018 (NI103018), NM103019 (NI103019), NM103020 (NI103020), NM103021 (NI103021), NM103022 (NI103022), NM103023 (NI103023), NM103024 (NI103024), NM103074 (NI103074), NM103079 (NI103079), NM103082 (NI103082), NM103083 (NI103083), NM103084 (NI103084), NM103085 (NI103085), NM103087 (NI103087), NM103088 (NI103088), NM103089 (NI103089), NM103091 (NI103091), NM103093 (NI103093), NM103094 (NI103094), NM103095 (NI103095), NM103104 (NI103104), NM103116 (NI103116), NM103117 (NI103117), NM103120 (NI103120), NM103122 (NI103122), NM103123 (NI103123), NM103126 (NI103126), NM103127 (NI103127), NM103131 (NI103131), NM103136 (NI103136), NM103139 (NI103139), NM103144 (NI103144), NM103145 (NI103145), NM103146 (NI103146), NM103147 (NI103147), NM103148 (NI103148), NM103151 (NI103151), NM103152 (NI103152), NM103153 (NI103153), NM103155 (NI103155), NM103157 (NI103157), NM103159 (NI103159), NM103168 (NI103168), NM103170 (NI103170), NM103181 (NI103181), NM103182 (NI103182), NM103183 (NI103183), NM103189 (NI103189), NM103196 (NI103196), NM103203 (NI103203), NM103204 (NI103204), NM103208 (NI103208), NM103215 (NI103215), NM103220 (NI103220).", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3165-2026%22", "url": "https://recallledger.net/recalls/device-z-3165-2026-noxboxi-nitric-oxide-delivery-system/"}, {"id": "fda-device-z-3154-2026", "source": "FDA", "category": "device", "recall_number": "Z-3154-2026", "title": "Haylard UNIV IMAGING 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"https://recallledger.net/recalls/device-z-3154-2026-haylard-univ-imaging-biopsy-trucustom-model-item-number-kit-varv/"}, {"id": "fda-device-z-3153-2026", "source": "FDA", "category": "device", "recall_number": "Z-3153-2026", "title": "Haylard BASIC BIOPSY TRAY recall (AVID Medical, Inc.)", "product": "Haylard BASIC BIOPSY TRAY;   Model/Item Number (Kit): PM415;", "reason": "Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.", "hazard_level": "Class I", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: IL, NC, VA, WY;", "states": ["IL", "NC", "VA", "WY"], "nationwide": false, "quantity": "240 kits", "codes": "Model/Item Number (Kit): PM415; UDI-DI: 10809160322154; Kit Lots: 1652485, 1656642, 1667835, 1676219, 1682251, 1691940; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3153-2026%22", "url": "https://recallledger.net/recalls/device-z-3153-2026-haylard-basic-biopsy-tray-model-item-number-kit-pm415/"}, {"id": "fda-device-z-3152-2026", "source": "FDA", "category": "device", "recall_number": "Z-3152-2026", "title": "Haylard CONTINUOUS NERVE BLOCK TRAY recall (AVID Medical, Inc.)", "product": "Haylard CONTINUOUS NERVE BLOCK TRAY;   Model/Item Number (Kit): BMCN001-05;", "reason": "Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.", "hazard_level": "Class I", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: IL, NC, VA, WY;", "states": ["IL", "NC", "VA", "WY"], "nationwide": false, "quantity": "80 kits", "codes": "Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3152-2026%22", "url": "https://recallledger.net/recalls/device-z-3152-2026-haylard-continuous-nerve-block-tray-model-item-number-kit-bmcn00/"}, {"id": "fda-device-z-3151-2026", "source": "FDA", "category": "device", "recall_number": "Z-3151-2026", "title": "Haylard 18G SINGLE SHOT EPI TRAY recall (AVID Medical, Inc.)", "product": "Haylard 18G SINGLE SHOT EPI TRAY;   Model/Item Number (Kit): DPGE002-02;", "reason": "Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.", "hazard_level": "Class I", "company": "AVID Medical, Inc.", "company_location": "Toano, VA, United States", "date": "2026-08-10", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: IL, NC, VA, WY;", "states": ["IL", "NC", "VA", "WY"], "nationwide": false, "quantity": "1640 kits", "codes": "Model/Item Number (Kit): DPGE002-02; UDI-DI: 10809160410325; Kit Lots: 1641713, 1641714, 1659697, 1668209; Recalled Sodium Chloride Ampule Lot: AB4003;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3151-2026%22", "url": "https://recallledger.net/recalls/device-z-3151-2026-haylard-18g-single-shot-epi-tray-model-item-number-kit-dpge002-0/"}, {"id": "fda-device-z-3150-2026", "source": "FDA", "category": "device", "recall_number": "Z-3150-2026", "title": "Impella Optical Controller recall (Abiomed, Inc.)", "product": "Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;", "reason": "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.", "hazard_level": "Class I", "company": "Abiomed, Inc.", "company_location": "Danvers, MA, United States", "date": "2026-08-12", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: Nationwide Distribution.  International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;", "states": [], "nationwide": true, "quantity": "4100 units (2785 US, 1315 OUS) 11 10", "codes": "1. Optical, AIC, Impella Connect, Packaged, AU;  Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753;  2. Optical, AIC, Impella Connect, Packaged, CA;  Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802;  3. Optical, AIC, Impella Connect, Packaged, EU;  Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012, IC12015, IC12447, IC12483, IC12814, IC13029, IC13030, IC13031, IC9010, IC9011, IC9949, IC9950, IC10146, IC10180, IC10371, IC10372, IC10396, IC10397, IC10665, IC10670, IC10671, IC10673, IC10721, IC10772, IC10828, IC10835, IC11072, IC11116, IC11119, IC11132, IC11138, IC11140, IC11146, IC11679, IC11706, IC11712, IC11713, IC11721, IC11878, IC11951, IC11958, IC11967, IC11969, IC11978, IC11986, IC11992, IC11997, IC12260, IC12261, IC12446, IC12454, IC12458, IC12459, IC12463, IC12465, IC12466, IC12544, IC12546, IC12555, IC12565, IC12566, IC12586, IC12593, IC12594, IC12595, IC12596, IC12666, IC12670, IC12744, IC12747, IC12749, IC12750, IC12761, IC12764, IC12771, IC12810, IC12822, IC12828, IC12845, IC12929, IC13034, IC13035, IC13041, IC13047, IC13053, IC13118, IC13122, IC13135, IC13199, IC13226, IC13245, IC13246, IC13360, IC13364, IC13627, IC13635, IC13640, IC13642, IC12768, IC13023, IC13322, IC9071, IC9073, IC10126, IC10139, IC10169, IC10174, IC10392, IC10556, IC10558, IC10628, IC10632, IC10674, IC10677, IC10678, IC10680, IC11215, IC11217, IC11219, IC11220, IC11281, IC11283, IC11289, IC11358, IC11879, IC11904, IC11911, IC11930, IC11945, IC11952, IC11959, IC11960, IC11961, IC11966, IC11970, IC11973, IC11974, IC11976, IC11989, IC11991, IC12195, IC12206, IC12210, IC12213, IC12216, IC12217, IC12257, IC12258, IC12262, IC12265, IC12267, IC12269, IC12270, IC12272, IC12273, IC12274, IC12276, IC12277, IC12307, IC12309, IC12310, IC12319, IC12455, IC12456, IC12457, IC12467, IC12481, IC12484, IC12485, IC12488, IC12491, IC12494, IC12548, IC12551, IC12553, IC12765, IC12767, IC12812, IC12816, IC12824, IC12835, IC12942, IC12951, IC13177, IC13192, IC13291, IC13298, IC13328, IC13329, IC13330, IC13331, IC13352, IC13354, IC13363, IC13365, IC13366, IC13628, IC13636, IC9726, IC9727, IC9729, IC9730, IC9761, IC9830, IC9959, IC9965, IC10154, IC10159, IC10171, IC10175, IC10394, IC10400, IC10938, IC10952, IC11305, IC11715, IC11722, IC12001, IC12220, IC12221, IC12524, IC12542, IC12671, IC12672, IC8840, IC9252, IC9757, IC9759, IC10779, IC10782, IC10181, IC10184, IC10185, IC10186, IC10326, IC10360, IC10369, IC10540, IC10541, IC10544, IC10551, IC10555, IC10559, IC10627, IC10639, IC10679, IC10682, IC10707, IC10710, IC10711, IC10713, IC10809, IC11007, IC11010, IC11011, IC11090, IC11221, IC11223, IC11234, IC11363, IC11368, IC11717, IC11718, IC11719, IC11910, IC11913, IC11931, IC11948, IC11949, IC11955, IC11980, IC11983, IC12259, IC12263, IC12264, IC12266, IC12281, IC12282, IC12290, IC12311, IC12314, IC12486, IC12490, IC12496, IC12497, IC12576, IC12577, IC12695, IC12696, IC12697, IC12698, IC12699, IC12700, IC12702, IC12703, IC12704, IC12753, IC12754, IC12755, IC12756, IC12757, IC12802, IC12809, IC13069, IC13072, IC13120, IC13121, IC13133, IC13134, IC13136, IC13138, IC13165, IC13213, IC13248, IC13249, IC13281, IC13282, IC13293, IC13297, IC13371, IC13372, IC13565, IC13638, IC13639, IC13643, IC13645, IC13650, IC13653, IC8821, IC8822, IC8823, IC8825, IC8826, IC9002A, IC9015, IC9023, IC9024, IC9051, IC9052, IC9072, IC9076, IC9077, IC9078, IC9106, IC9107, IC9108, IC9109, IC9110, IC9111, IC9112, IC9113, IC9114, IC9115, IC9169, IC9171, IC9176, IC9216, IC9217, IC9251, IC9253, IC9257, IC9260, IC9342, IC9345, IC9352, IC9424, IC9427, IC9762, IC9763, IC9764, IC9765, IC9766, IC9824, IC9945, IC9948, IC13709, IC13710, IC13711, IC13712, IC10123, IC10124, IC10127, IC10138, IC10140, IC10141, IC10142, IC10143, IC10144, IC10148, IC10152, IC10155, IC10157, IC10158, IC10161, IC10166, IC10173, IC10176, IC10256, IC10257, IC10258, IC10259, IC10260, IC10261, IC10262, IC10263, IC10264, IC10265, IC10329, IC10347, IC10370, IC10389, IC10393, IC10395, IC10398, IC10401, IC10404, IC10408, IC10415, IC10416, IC10423, IC10424, IC10425, IC10433, IC10434, IC10437, IC10438, IC10439, IC10440, IC10442, IC10468, IC10506, IC10510, IC10542, IC10543, IC10552, IC10591, IC10621, IC10633, IC10634, IC10635, IC10636, IC10638, IC10720, IC10738, IC10767, IC10768, IC10778, IC10781, IC10819, IC10858, IC10870, IC10883, IC10884, IC10898, IC10909, IC10917, IC10919, IC10939, IC10943, IC10944, IC10945, IC10947, IC10948, IC10949, IC10953, IC10954, IC10955, IC11003, IC11004, IC11005, IC11009, IC11095, IC11120, IC11122, IC11124, IC11127, IC11133, IC11136, IC11137, IC11141, IC11142, IC11149, IC11193, IC11209, IC11214, IC11224, IC11225, IC11226, IC11228, IC11233, IC11235, IC11277, IC11278, IC11279, IC11280, IC11286, IC11287, IC11288, IC11322, IC11328, IC11332, IC11334, IC11360, IC11361, IC11364, IC11367, IC11699, IC11705, IC11707, IC11708, IC11709, IC11710, IC11711, IC11900, IC11909, IC11928, IC11929, IC11934, IC11937, IC11942, IC11943, IC11946, IC11947, IC11950, IC11953, IC11954, IC11956, IC11957, IC11962, IC11963, IC11971, IC11975, IC11977, IC11981, IC11984, IC11985, IC11987, IC11988, IC11993, IC11995, IC12002, IC12014, IC12208, IC12212, IC12219, IC12222, IC12223, IC12271, IC12275, IC12280, IC12287, IC12289, IC12291, IC12308, IC12312, IC12313, IC12320, IC12442, IC12451, IC12453, IC12464, IC12470, IC12487, IC12493, IC12495, IC12523, IC12536, IC12538, IC12541, IC12550, IC12554, IC12556, IC12558, IC12567, IC12568, IC12574, IC12575, IC12585, IC12590, IC12591, IC12597, IC12640, IC12648, IC12667, IC12668, IC12673, IC12751, IC12759, IC12760, IC12763, IC12805, IC12807, IC12811, IC12821, IC12827, IC12829, IC12833, IC12834, IC12854, IC12865, IC12939, IC12940, IC12941, IC12944, IC12946, IC12947, IC12948, IC13003, IC13026, IC13036, IC13081, IC13097, IC13098, IC13100, IC13101, IC13103, IC13104, IC13105, IC13106, IC13107, IC13119, IC13137, IC13178, IC13183, IC13186, IC13292, IC13295, IC13296, IC13318, IC13319, IC13321, IC13332, IC13353, IC13355, IC13359, IC13367, IC13369, IC13370, IC13374, IC13731, IC13741, IC13751, IC13752, IC13762, IC13775, IC13777, IC13778, IC13779, IC13780, IC13806, IC8818, IC8819, IC8820, IC8824, IC8827, IC8836, IC8837, IC8838, IC8839, IC8841, IC8842, IC8865, IC8866, IC8868, IC8869, IC8870, IC8871, IC8872, IC8873, IC8874, IC8876, IC8898, IC8899, IC8900, IC8901, IC8902, IC8910, IC8911, IC8912, IC8913, IC8914, IC9000A, IC9001A, IC9003A, IC9004A, IC9009, IC9012, IC9013, IC9014, IC9016, IC9017, IC9019, IC9020, IC9021, IC9022, IC9039, IC9050, IC9069, IC9070, IC9075, IC9167, IC9168, IC9170, IC9172, IC9173, IC9174, IC9175, IC9179, IC9180, IC9189, IC9190, IC9191, IC9193, IC9194, IC9215, IC9254, IC9255, IC9256, IC9258, IC9259, IC9281, IC9330, IC9343, IC9389, IC9396, IC9398, IC9401, IC9425, IC9426, IC9429, IC9552, IC9553, IC9554, IC9555, IC9556, IC9643, IC9687, IC9689, IC9692, IC9693, IC9758, IC9760, IC9828, IC9868, IC9942, IC9944, IC9951, IC9954, IC9955, IC9956, IC9957, IC9958, IC9960, IC9966, IC9967, IC9968, IC12826, IC12831, IC13629, IC13647, IC9192, IC10560, IC10590, IC10698, IC10706, IC10773, IC10775, IC10799, IC10820, IC10885, IC10886, IC10890, IC10891, IC10892, IC10916, IC10920, IC10921, IC10940, IC10942, IC10946, IC10951, IC11074, IC11121, IC11229, IC11240, IC11302, IC11366, IC11714, IC11716, IC11914, IC11915, IC11964, IC11965, IC11968, IC11998, IC12000, IC12215, IC12218, IC12284, IC12288, IC12443, IC12444, IC12445, IC12452, IC12545, IC12552, IC12587, IC12762, IC12803, IC12815, IC12931, IC13017, IC13024, IC13091, IC13092, IC13099, IC13108, IC13109, IC13187, IC13294, IC9420, IC9428, IC9430, IC9431, IC9690, IC9827, IC9962, IC9964, IC10125, IC10156, IC10167, IC10168, IC10172, IC10183, IC10950, IC11999, IC12278, IC12480, IC12543, IC12766, IC12830, IC12933, IC13191, IC13247, IC13320, IC13356, IC13113, IC13127, IC13180, IC13193, IC10402, IC10403, IC10441, IC10505, IC10507, IC10508, IC10675, IC10676, IC12801, IC12808, IC9399, IC9402, IC9623, IC9626, IC9644, IC9645, IC9647, IC10153, IC10160, IC10580, IC10629, IC10887, IC10889, IC11006, IC11321, IC11323, IC11324, IC11326, IC11330, IC11331, IC11726, IC12013, IC12224, IC12549, IC12649, IC12786, IC12988, IC13020, IC13102, IC13132, IC13181, IC13184, IC9403, IC9404, IC9624, IC9646, IC9896, IC9946, IC9728, IC13142, IC13143, IC13144, IC13146, IC13148, IC13150, IC13151, IC13156, IC13157, IC13158;  4. Optical, AIC, Impella Connect, Packaged, JP;  Product Code: 0042-0040-JP; UDI-DI: 00813502011814; Serial Numbers: IC10016, IC10018, IC10019, IC10020, IC10021, IC10022, IC10068, IC10107, IC10119, IC10120, IC10272, IC10273, IC10274, IC10275, IC10276, IC10280, IC10290, IC10354, IC10355, IC10356, IC10357, IC10359, IC10363, IC10368, IC10405, IC10409, IC10413, IC10426, IC10427, IC10503, IC10504, IC10536, IC10537, IC10538, IC10539, IC10563, IC10583, IC10699, IC10700, IC10705, IC10806, IC10807, IC10810, IC10869, IC10906, IC10907, IC10928, IC10930, IC10931, IC10932, IC11088, IC11192, IC11195, IC11218, IC11253, IC11339, IC11340, IC11370, IC11376, IC11378, IC11405, IC11417, IC11453, IC11454, IC11459, IC11499, IC11570, IC11623, IC11636, IC11666, IC11672, IC11678, IC11687, IC11689, IC11690, IC11694, IC11720, IC11725, IC11727, IC11738, IC11743, IC11750, IC11751, IC11777, IC11778, IC12026, IC12028, IC12029, IC12030, IC12031, IC12404, IC12405, IC12434, IC12437, IC12438, IC12515, IC12516, IC12517, IC12518, IC12609, IC12610, IC12612, IC12613, IC12614, IC12617, IC12618, IC12619, IC12620, IC12752, IC12769, IC12775, IC12776, IC12841, IC12843, IC12846, IC12849, IC12852, IC12853, IC13258, IC13259, IC13324, IC13326, IC13392, IC13393, IC8196, IC8197, IC8237, IC8238, IC8239, IC8240, IC8241, IC8245, IC8246, IC8298, IC8299, IC8301, IC8302, IC8303, IC8304, IC8306, IC8309, IC8310, IC8364, IC8369, IC8370, IC8371, IC8372, IC8374, IC8375, IC8491, IC8492, IC8523, IC8524, IC8526, IC8531, IC8571, IC8573, IC8583, IC8595, IC8597, IC8599, IC8601, IC8619, IC8626, IC8666, IC8670, IC8679, IC8680, IC8681, IC8682, IC8684, IC8685, IC8687, IC8731, IC8732, IC8733, IC8734, IC8735, IC8779, IC8780, IC8782, IC8784, IC8785, IC8886, IC8887, IC8888, IC8889, IC8890, IC8892, IC8893, IC8894, IC8896, IC8897, IC8915, IC8916, IC8917, IC8918, IC8919, IC8921, IC8922, IC8923, IC8924, IC8927, IC8937, IC9125, IC9126, IC9127, IC9128, IC9129, IC9130, IC9131, IC9132, IC9134, IC9135, IC9136, IC9137, IC9138, IC9139, IC9140, IC9288, IC9289, IC9290, IC9291, IC9292, IC9294, IC9295, IC9298, IC9321, IC9322, IC9323, IC9325, IC9326, IC9329, IC9331, IC9332, IC9411, IC9462, IC9463, IC9485, IC9489, IC9490, IC9491, IC9492, IC9494, IC9495, IC9496, IC9497, IC9498, IC9499, IC9540, IC9559, IC9560, IC9561, IC9562, IC9563, IC9580, IC9694, IC9702, IC9703, IC9704, IC9705, IC9707, IC9708, IC9709, IC9786, IC9787, IC9790, IC9791, IC9811, IC9838, IC9894, IC9923, IC9925, IC9926, IC9927, IC9928, IC9929, IC9930, IC9931;  5. Optical, AIC, Impella Connect, Packaged, UK;  Product Code: 0042-0040-UK; UDI-DI: 00813502012484; Serial Numbers: IC10008, IC10011, IC10025, IC10240, IC10241, IC10592, IC10593, IC10598, IC10601, IC11196, IC11197, IC11198, IC11640, IC11642, IC11645, IC11646, IC12714, IC12717, IC12725, IC12727, IC12728, IC9990, IC12255, IC10164, IC10165, IC12315, IC12318, IC12561, IC12563, IC12726, IC13338, IC10224, IC10225, IC10788, IC10789, IC10790, IC10792, IC10793, IC11723, IC11724, IC12256, IC12716, IC12718, IC13235, IC11682, IC11683;  6. Optical, AIC, Impella Connect, Packaged, US;  Product Code: 0042-0040-US; UDI-DI: 00813502011401; Serial Numbers: IC10000, IC10001, IC10002, IC10003, IC10004, IC10005, IC10006, IC10007, IC10009, IC10010, IC10026, IC10027, IC10028, IC10029, IC10030, IC10031, IC10036, IC10038, IC10041, IC10042, IC10045, IC10046, IC10047, IC10048, IC10050, IC10051, IC10052, IC10053, IC10054, IC10055, IC10056, IC10057, IC10058, IC10059, IC10060, IC10061, IC10062, IC10065, IC10067, IC10069, IC10070, IC10071, IC10072, IC10073, IC10074, IC10075, IC10076, IC10077, IC10078, IC10079, IC10080, IC10081, IC10082, IC10083, IC10084, IC10085, IC10086, IC10087, IC10088, IC10089, IC10090, IC10091, IC10092, IC10093, IC10094, IC10095, IC10096, IC10097, IC10098, IC10099, IC10100, IC10101, IC10104, IC10110, IC10111, IC10112, IC10113, IC10114, IC10115, IC10116, IC10117, IC10118, IC10128, IC10129, IC10130, IC10131, IC10132, IC10133, IC10134, IC10135, IC10136, IC10137, IC10147, IC10151, IC10187, IC10188, IC10189, IC10190, IC10191, IC10192, IC10193, IC10194, IC10195, IC10196, IC10197, IC10198, IC10199, IC10200, IC10201, IC10202, IC10203, IC10204, IC10205, IC10206, IC10207, IC10208, IC10209, IC10210, IC10211, IC10212, IC10213, IC10214, IC10215, IC10216, IC10217, IC10218, IC10219, IC10220, IC10221, IC10222, IC10223, IC10226, IC10227, IC10228, IC10229, IC10230, IC10231, IC10232, IC10233, IC10235, IC10237, IC10242, IC10246, IC10247, IC10248, IC10249, IC10250, IC10251, IC10252, IC10253, IC10254, IC10255, IC10266, IC10269, IC10271, IC10277, IC10279, IC10282, IC10283, IC10284, IC10285, IC10286, IC10287, IC10288, IC10289, IC10291, IC10292, IC10293, IC10294, IC10295, IC10296, IC10297, IC10298, IC10299, IC10301, IC10303, IC10304, IC10307, IC10308, IC10309, IC10310, IC10311, IC10313, IC10314, IC10315, IC10316, IC10317, IC10321, IC10322, IC10323, IC10324, IC10325, IC10327, IC10328, IC10330, IC10331, IC10332, IC10333, IC10334, IC10335, IC10336, IC10337, IC10339, IC10340, IC10342, IC10343, IC10344, IC10345, IC10346, IC10348, IC10349, IC10350, IC10351, IC10352, IC10358, IC10361, IC10373, IC10374, IC10375, IC10376, IC10377, IC10378, IC10379, IC10380, IC10381, IC10383, IC10384, IC10385, IC10386, IC10390, IC10391, IC10407, IC10410, IC10412, IC10418, IC10420, IC10421, IC10422, IC10428, IC10429, IC10430, IC10431, IC10432, IC10435, IC10436, IC10443, IC10444, IC10445, IC10446, IC10447, IC10448, IC10449, IC10450, IC10451, IC10452, IC10453, IC10454, IC10455, IC10459, IC10461, IC10462, IC10466, IC10470, IC10471, IC10472, IC10474, IC10475, IC10476, IC10477, IC10478, IC10479, IC10480, IC10481, IC10482, IC10484, IC10485, IC10486, IC10487, IC10509, IC10511, IC10512, IC10514, IC10515, IC10516, IC10519, IC10520, IC10521, IC10522, IC10523, IC10524, IC10525, IC10526, IC10527, IC10528, IC10529, IC10530, IC10531, IC10532, IC10533, IC10534, IC10535, IC10545, IC10546, IC10548, IC10549, IC10550, IC10553, IC10554, IC10557, IC10561, IC10562, IC10564, IC10565, IC10566, IC10567, IC10568, IC10569, IC10570, IC10571, IC10572, IC10578, IC10581, IC10582, IC10596, IC10597, IC10599, IC10600, IC10602, IC10603, IC10604, IC10605, IC10606, IC10607, IC10608, IC10609, IC10610, IC10611, IC10612, IC10613, IC10614, IC10615, IC10616, IC10617, IC10618, IC10619, IC10620, IC10622, IC10623, IC10624, IC10625, IC10626, IC10637, IC10642, IC10643, IC10644, IC10647, IC10653, IC10654, IC10655, IC10656, IC10657, IC10658, IC10659, IC10660, IC10661, IC10662, IC10669, IC10684, IC10685, IC10687, IC10688, IC10690, IC10691, IC10692, IC10693, IC10694, IC10695, IC10696, IC10697, IC10704, IC10708, IC10709, IC10712, IC10714, IC10715, IC10716, IC10717, IC10718, IC10719, IC10722, IC10723, IC10724, IC10725, IC10726, IC10728, IC10729, IC10730, IC10731, IC10732, IC10733, IC10734, IC10736, IC10737, IC10739, IC10740, IC10741, IC10742, IC10743, IC10744, IC10745, IC10746, IC10749, IC10750, IC10751, IC10752, IC10753, IC10754, IC10756, IC10757, IC10758, IC10759, IC10760, IC10763, IC10764, IC10769, IC10770, IC10774, IC10776, IC10777, IC10783, IC10787, IC10791, IC10795, IC10796, IC10800, IC10811, IC10812, IC10813, IC10814, IC10815, IC10816, IC10817, IC10818, IC10821, IC10822, IC10823, IC10824, IC10825, IC10826, IC10830, IC10831, IC10832, IC10833, IC10838, IC10839, IC10842, IC10845, IC10847, IC10848, IC10850, IC10852, IC10855, IC10856, IC10857, IC10859, IC10860, IC10861, IC10873, IC10875, IC10876, IC10877, IC10878, IC10879, IC10880, IC10881, IC10888, IC10895, IC10897, IC10899, IC10900, IC10901, IC10908, IC10910, IC10911, IC10912, IC10913, IC10915, IC10918, IC10922, IC10923, IC10924, IC10925, IC10926, IC10927, IC10929, IC10934, IC10935, IC10936, IC10937, IC10941, IC10957, IC10958, IC10959, IC10962, IC10971, IC10972, IC10974, IC10975, IC10978, IC10980, IC10981, IC10982, IC10998, IC10999, IC11001, IC11002, IC11008, IC11012, IC11013, IC11014, IC11016, IC11017, IC11018, IC11021, IC11022, IC11024, IC11030, IC11031, IC11032, IC11033, IC11034, IC11035, IC11036, IC11037, IC11038, IC11039, IC11040, IC11041, IC11042, IC11043, IC11044, IC11045, IC11046, IC11047, IC11051, IC11052, IC11053, IC11054, IC11056, IC11058, IC11059, IC11060, IC11062, IC11063, IC11064, IC11065, IC11066, IC11068, IC11069, IC11070, IC11073, IC11075, IC11076, IC11077, IC11078, IC11079, IC11080, IC11081, IC11082, IC11085, IC11087, IC11092, IC11093, IC11094, IC11096, IC11103, IC11106, IC11107, IC11108, IC11109, IC11117, IC11129, IC11139, IC11147, IC11150, IC11154, IC11155, IC11156, IC11157, IC11158, IC11159, IC11160, IC11161, IC11163, IC11164, IC11165, IC11166, IC11167, IC11168, IC11169, IC11170, IC11173, IC11175, IC11176, IC11178, IC11179, IC11180, IC11181, IC11184, IC11185, IC11187, IC11188, IC11189, IC11191, IC11194, IC11200, IC11203, IC11205, IC11206, IC11207, IC11208, IC11241, IC11242, IC11243, IC11244, IC11245, IC11246, IC11247, IC11249, IC11251, IC11268, IC11269, IC11270, IC11271, IC11272, IC11273, IC11274, IC11275, IC11276, IC11284, IC11285, IC11290, IC11291, IC11292, IC11293, IC11294, IC11295, IC11296, IC11297, IC11298, IC11310, IC11312, IC11313, IC11314, IC11315, IC11316, IC11318, IC11319, IC11320, IC11327, IC11333, IC11335, IC11347, IC11348, IC11349, IC11350, IC11351, IC11352, IC11353, IC11354, IC11355, IC11356, IC11357, IC11359, IC11362, IC11371, IC11373, IC11374, IC11375, IC11380, IC11381, IC11382, IC11383, IC11384, IC11385, IC11386, IC11387, IC11388, IC11389, IC11390, IC11391, IC11392, IC11394, IC11395, IC11396, IC11397, IC11398, IC11402, IC11403, IC11406, IC11408, IC11409, IC11411, IC11412, IC11415, IC11418, IC11419, IC11420, IC11421, IC11422, IC11423, IC11424, IC11425, IC11426, IC11427, IC11428, IC11429, IC11430, IC11431, IC11432, IC11433, IC11434, IC11435, IC11437, IC11438, IC11439, IC11443, IC11446, IC11447, IC11452, IC11457, IC11458, IC11460, IC11461, IC11464, IC11465, IC11466, IC11467, IC11469, IC11471, IC11473, IC11474, IC11477, IC11478, IC11479, IC11480, IC11481, IC11482, IC11484, IC11486, IC11488, IC11492, IC11493, IC11495, IC11503, IC11510, IC11511, IC11512, IC11513, IC11514, IC11518, IC11519, IC11521, IC11522, IC11523, IC11524, IC11525, IC11526, IC11528, IC11529, IC11530, IC11531, IC11532, IC11533, IC11534, IC11535, IC11536, IC11537, IC11538, IC11539, IC11540, IC11549, IC11550, IC11551, IC11552, IC11555, IC11556, IC11557, IC11558, IC11559, IC11560, IC11561, IC11563, IC11564, IC11565, IC11567, IC11568, IC11569, IC11572, IC11573, IC11574, IC11581, IC11582, IC11583, IC11584, IC11585, IC11586, IC11597, IC11606, IC11609, IC11610, IC11613, IC11614, IC11615, IC11617, IC11618, IC11621, IC11622, IC11624, IC11625, IC11626, IC11627, IC11628, IC11629, IC11631, IC11632, IC11633, IC11634, IC11635, IC11637, IC11638, IC11639, IC11641, IC11644, IC11654, IC11662, IC11680, IC11684, IC11686, IC11692, IC11695, IC11696, IC11697, IC11700, IC11702, IC11704, IC11753, IC11754, IC11755, IC11756, IC11757, IC11758, IC11759, IC11760, IC11761, IC11762, IC11763, IC11764, IC11765, IC11766, IC11767, IC11768, IC11769, IC11770, IC11773, IC11774, IC11776, IC11779, IC11781, IC11783, IC11784, IC11785, IC11786, IC11787, IC11788, IC11790, IC11791, IC11792, IC11793, IC11795, IC11796, IC11797, IC11798, IC11799, IC11800, IC11801, IC11802, IC11803, IC11804, IC11805, IC11806, IC11807, IC11808, IC11809, IC11810, IC11811, IC11812, IC11813, IC11814, IC11815, IC11816, IC11817, IC11818, IC11821, IC11822, IC11823, IC11824, IC11825, IC11826, IC11827, IC11828, IC11829, IC11830, IC11831, IC11832, IC11833, IC11834, IC11835, IC11836, IC11837, IC11838, IC11839, IC11840, IC11841, IC11842, IC11843, IC11844, IC11845, IC11846, IC11847, IC11848, IC11849, IC11850, IC11851, IC11852, IC11853, IC11854, IC11856, IC11857, IC11860, IC11861, IC11862, IC11863, IC11864, IC11866, IC11868, IC11869, IC11870, IC11871, IC11872, IC11873, IC11874, IC11875, IC11876, IC11877, IC11881, IC11882, IC11883, IC11884, IC11885, IC11886, IC11887, IC11888, IC11889, IC11890, IC11891, IC11892, IC11894, IC11896, IC11897, IC11898, IC11899, IC11901, IC11902, IC11903, IC11905, IC11906, IC11907, IC11908, IC11912, IC11916, IC11917, IC11918, IC11919, IC11920, IC11921, IC11923, IC11925, IC11926, IC11927, IC11932, IC11933, IC11935, IC11936, IC11938, IC11939, IC11940, IC11944, IC11979, IC11982, IC11990, IC11994, IC11996, IC12003, IC12004, IC12005, IC12006, IC12007, IC12009, IC12010, IC12011, IC12016, IC12017, IC12018, IC12019, IC12020, IC12021, IC12022, IC12023, IC12024, IC12025, IC12033, IC12034, IC12035, IC12036, IC12037, IC12038, IC12039, IC12040, IC12041, IC12042, IC12044, IC12045, IC12046, IC12047, IC12048, IC12049, IC12050, IC12051, IC12052, IC12053, IC12055, IC12056, IC12057, IC12058, IC12059, IC12060, IC12061, IC12062, IC12064, IC12065, IC12066, IC12070, IC12072, IC12073, IC12074, IC12075, IC12076, IC12077, IC12078, IC12079, IC12080, IC12081, IC12082, IC12083, IC12084, IC12085, IC12086, IC12087, IC12088, IC12089, IC12090, IC12091, IC12092, IC12093, IC12094, IC12095, IC12096, IC12097, IC12098, IC12099, IC12100, IC12102, IC12103, IC12104, IC12105, IC12106, IC12107, IC12109, IC12110, IC12111, IC12112, IC12113, IC12114, IC12115, IC12116, IC12117, IC12118, IC12119, IC12120, IC12121, IC12122, IC12124, IC12125, IC12126, IC12128, IC12129, IC12130, IC12131, IC12132, IC12133, IC12134, IC12135, IC12136, IC12137, IC12138, IC12139, IC12140, IC12141, IC12142, IC12143, IC12144, IC12145, IC12146, IC12147, IC12148, IC12149, IC12150, IC12152, IC12153, IC12154, IC12155, IC12156, IC12157, IC12158, IC12159, IC12160, IC12161, IC12162, IC12164, IC12165, IC12166, IC12167, IC12168, IC12169, IC12170, IC12171, IC12172, IC12173, IC12174, IC12175, IC12176, IC12177, IC12178, IC12179, IC12180, IC12181, IC12182, IC12183, IC12184, IC12185, IC12186, IC12188, IC12189, IC12190, IC12191, IC12192, IC12193, IC12194, IC12196, IC12197, IC12198, IC12199, IC12200, IC12201, IC12202, IC12203, IC12204, IC12205, IC12207, IC12209, IC12211, IC12225, IC12226, IC12227, IC12228, IC12229, IC12230, IC12231, IC12232, IC12233, IC12234, IC12235, IC12236, IC12237, IC12238, IC12239, IC12240, IC12241, IC12242, IC12243, IC12244, IC12246, IC12247, IC12249, IC12250, IC12251, IC12252, IC12253, IC12254, IC12268, IC12283, IC12285, IC12286, IC12292, IC12293, IC12294, IC12295, IC12296, IC12297, IC12298, IC12299, IC12300, IC12301, IC12302, IC12303, IC12304, IC12305, IC12306, IC12347, IC12348, IC12349, IC12350, IC12351, IC12352, IC12353, IC12354, IC12355, IC12356, IC12357, IC12358, IC12360, IC12361, IC12362, IC12363, IC12364, IC12365, IC12366, IC12367, IC12368, IC12369, IC12370, IC12371, IC12372, IC12373, IC12374, IC12375, IC12376, IC12377, IC12381, IC12382, IC12383, IC12384, IC12385, IC12386, IC12387, IC12388, IC12389, IC12390, IC12391, IC12396, IC12399, IC12400, IC12406, IC12426, IC12428, IC12430, IC12433, IC12435, IC12436, IC12440, IC12441, IC12448, IC12449, IC12450, IC12460, IC12461, IC12462, IC12468, IC12469, IC12472, IC12473, IC12474, IC12475, IC12476, IC12477, IC12478, IC12557, IC12592, IC12601, IC12602, IC12611, IC12621, IC12622, IC12623, IC12624, IC12625, IC12626, IC12628, IC12629, IC12630, IC12631, IC12632, IC12633, IC12634, IC12635, IC12636, IC12637, IC12638, IC12639, IC12641, IC12642, IC12643, IC12644, IC12645, IC12646, IC12647, IC12650, IC12651, IC12652, IC12653, IC12654, IC12655, IC12656, IC12658, IC12659, IC12660, IC12669, IC12676, IC12677, IC12678, IC12679, IC12680, IC12681, IC12682, IC12683, IC12684, IC12685, IC12686, IC12687, IC12688, IC12689, IC12690, IC12691, IC12692, IC12693, IC12694, IC12701, IC12705, IC12706, IC12707, IC12708, IC12709, IC12710, IC12711, IC12712, IC12729, IC12730, IC12731, IC12732, IC12733, IC12734, IC12735, IC12736, IC12737, IC12738, IC12739, IC12740, IC12741, IC12742, IC12743, IC12745, IC12746, IC12748, IC12777, IC12778, IC12779, IC12780, IC12781, IC12782, IC12783, IC12784, IC12785, IC12787, IC12788, IC12790, IC12791, IC12792, IC12793, IC12794, IC12795, IC12796, IC12797, IC12798, IC12799, IC12800, IC12806, IC12836, IC12842, IC12847, IC12848, IC12850, IC12851, IC12860, IC12861, IC12862, IC12863, IC12868, IC12871, IC12872, IC12873, IC12874, IC12875, IC12876, IC12877, IC12878, IC12879, IC12880, IC12886, IC12887, IC12893, IC12896, IC12897, IC12898, IC12899, IC12901, IC12902, IC12903, IC12904, IC12906, IC12907, IC12908, IC12909, IC12910, IC12911, IC12912, IC12913, IC12916, IC12918, IC12919, IC12920, IC12921, IC12922, IC12927, IC12928, IC12932, IC12934, IC12945, IC12967, IC12972, IC12979, IC12985, IC12986, IC12987, IC12989, IC12992, IC12995, IC12997, IC12998, IC13004, IC13005, IC13006, IC13007, IC13008, IC13009, IC13010, IC13012, IC13014, IC13015, IC13016, IC13018, IC13019, IC13025, IC13028, IC13032, IC13033, IC13043, IC13044, IC13050, IC13052, IC13054, IC13055, IC13056, IC13058, IC13067, IC13068, IC13073, IC13074, IC13075, IC13076, IC13124, IC13125, IC13126, IC13128, IC13129, IC13131, IC13141, IC13161, IC13162, IC13163, IC13164, IC13166, IC13173, IC13175, IC13179, IC13185, IC13189, IC13194, IC13195, IC13196, IC13217, IC13222, IC13224, IC13314, IC13316, IC13317, IC13361, IC13373, IC13375, IC13376, IC13377, IC13378, IC13379, IC13380, IC13381, IC13382, IC13383, IC13384, IC13385, IC13386, IC13387, IC13388, IC13389, IC13410, IC13411, IC13412, IC13413, IC13415, IC13416, IC13417, IC13418, IC13419, IC13420, IC13421, IC13427, IC13428, IC13429, IC13430, IC13431, IC13432, IC13433, IC13434, IC13435, IC13437, IC13438, IC13439, IC13440, IC13441, IC13442, IC13454, IC13456, IC13470, IC13472, IC13473, IC13474, IC13475, IC13476, IC13477, IC13478, IC13481, IC13483, IC13485, IC13488, IC13490, IC13491, IC13492, IC13495, IC13496, IC13497, IC13498, IC13501, IC13502, IC13506, IC13507, IC13508, IC13509, IC13510, IC13511, IC13512, IC13513, IC13514, IC13515, IC13516, IC13517, IC13519, IC13521, IC13533, IC13534, IC13535, IC13536, IC13537, IC13538, IC13543, IC13548, IC13549, IC13551, IC13552, IC13553, IC13554, IC13555, IC13556, IC13557, IC13558, IC13559, IC13562, IC13563, IC13564, IC13571, IC13572, IC13573, IC13575, IC13578, IC13589, IC13591, IC13592, IC13593, IC13594, IC13595, IC13596, IC13597, IC13598, IC13599, IC13600, IC13601, IC13602, IC13603, IC13604, IC13605, IC13606, IC13607, IC13608, IC13609, IC13610, IC13619, IC13620, IC13621, IC13622, IC13623, IC13624, IC13625, IC13626, IC13631, IC13632, IC13634, IC13637, IC13648, IC13649, IC13651, IC13652, IC13654, IC13655, IC13656, IC13657, IC13658, IC13659, IC13660, IC13661, IC13662, IC13664, IC13665, IC13666, IC13668, IC13669, IC13670, IC13671, IC13672, IC13673, IC13674, IC13675, IC13676, IC13680, IC13685, IC13692, IC13693, IC13694, IC13695, IC13697, IC13699, IC13700, IC13701, IC13704, IC13734, IC13736, IC13737, IC13738, IC13739, IC13740, IC13742, IC13743, IC13744, IC13745, IC13746, IC13747, IC13754, IC13755, IC13756, IC13757, IC13758, IC13759, IC13760, IC13765, IC13770, IC13771, IC13772, IC13773, IC13830, IC13831, IC13832, IC7182, IC7183, IC7184, IC7185, IC7186, IC7187, IC7188, IC7189, IC7190, IC7191, IC7339, IC7340, IC7341, IC7342, IC7343, IC7519, IC7520, IC7521, IC7560, IC7562, IC7563, IC7565, IC7566, IC7567, IC7568, IC7569, IC7571, IC7572, IC7631, IC7632, IC7633, IC7634, IC7635, IC7641, IC7643, IC7656, IC7684, IC7685, IC7696, IC7697, IC7698, IC7766, IC7767, IC7768, IC7769, IC7770, IC7831, IC7832, IC7833, IC7834, IC7835, IC7840, IC7841, IC7842, IC7843, IC7844, IC7845, IC7856, IC7857, IC7858, IC7859, IC7870, IC7871, IC7872, IC7873, IC7874, IC7875, IC7876, IC7881, IC7891, IC7892, IC7895, IC7907, IC7909, IC7912, IC7913, IC7914, IC7915, IC7916, IC7917, IC7918, IC7921, IC7923, IC7924, IC7925, IC7936, IC7938, IC7948, IC7949, IC7950, IC7951, IC7952, IC7960, IC7961, IC7962, IC7963, IC7986, IC7987, IC7988, IC7989, IC7990, IC7991, IC7992, IC7993, IC7994, IC7995, IC7997, IC7998, IC7999, IC8000, IC8001, IC8005, IC8007, IC8009, IC8010, IC8014, IC8015, IC8017, IC8018, IC8019, IC8020, IC8021, IC8022, IC8023, IC8024, IC8025, IC8027, IC8028, IC8030, IC8033, IC8036, IC8038, IC8039, IC8042, IC8043, IC8044, IC8045, IC8086, IC8087, IC8088, IC8089, IC8090, IC8091, IC8092, IC8093, IC8094, IC8095, IC8096, IC8097, IC8098, IC8099, IC8100, IC8108, IC8109, IC8110, IC8111, IC8112, IC8135, IC8136, IC8137, IC8138, IC8139, IC8140, IC8141, IC8142, IC8143, IC8144, IC8148, IC8149, IC8150, IC8151, IC8152, IC8154, IC8155, IC8156, IC8163, IC8176, IC8177, IC8178, IC8179, IC8180, IC8181, IC8182, IC8183, IC8184, IC8185, IC8191, IC8192, IC8193, IC8194, IC8195, IC8198, IC8199, IC8200, IC8211, IC8212, IC8213, IC8214, IC8215, IC8216, IC8231, IC8232, IC8233, IC8234, IC8235, IC8236, IC8247, IC8265, IC8270, IC8271, IC8272, IC8273, IC8274, IC8275, IC8286, IC8287, IC8288, IC8289, IC8290, IC8291, IC8292, IC8293, IC8305, IC8307, IC8312, IC8313, IC8314, IC8317, IC8318, IC8319, IC8320, IC8321, IC8322, IC8323, IC8324, IC8325, IC8326, IC8327, IC8328, IC8329, IC8330, IC8346, IC8347, IC8348, IC8349, IC8350, IC8351, IC8352, IC8353, IC8354, IC8355, IC8356, IC8357, IC8358, IC8359, IC8360, IC8361, IC8362, IC8363, IC8365, IC8366, IC8367, IC8380, IC8382, IC8383, IC8384, IC8385, IC8386, IC8390, IC8391, IC8392, IC8393, IC8394, IC8398, IC8399, IC8406, IC8407, IC8408, IC8411, IC8412, IC8413, IC8414, IC8415, IC8416, IC8417, IC8418, IC8429, IC8430, IC8431, IC8432, IC8433, IC8434, IC8435, IC8436, IC8437, IC8438, IC8440, IC8452, IC8453, IC8454, IC8455, IC8456, IC8458, IC8459, IC8460, IC8464, IC8466, IC8468, IC8469, IC8470, IC8471, IC8472, IC8473, IC8474, IC8475, IC8477, IC8478, IC8479, IC8480, IC8481, IC8483, IC8484, IC8485, IC8497, IC8500, IC8507, IC8508, IC8510, IC8517, IC8518, IC8519, IC8520, IC8521, IC8522, IC8528, IC8529, IC8530, IC8532, IC8533, IC8534, IC8535, IC8536, IC8537, IC8538, IC8539, IC8546, IC8552, IC8553, IC8562, IC8564, IC8566, IC8598, IC8602, IC8603, IC8604, IC8611, IC8613, IC8615, IC8617, IC8618, IC8620, IC8624, IC8627, IC8631, IC8632, IC8633, IC8634, IC8635, IC8636, IC8637, IC8638, IC8656, IC8667, IC8668, IC8669, IC8671, IC8672, IC8673, IC8674, IC8675, IC8676, IC8678, IC8688, IC8689, IC8695, IC8702, IC8709, IC8710, IC8711, IC8712, IC8713, IC8715, IC8716, IC8717, IC8718, IC8719, IC8720, IC8721, IC8722, IC8724, IC8730, IC8738, IC8742, IC8743, IC8744, IC8745, IC8746, IC8747, IC8756, IC8757, IC8758, IC8759, IC8760, IC8766, IC8769, IC8770, IC8771, IC8772, IC8773, IC8776, IC8777, IC8778, IC8783, IC8786, IC8787, IC8789, IC8790, IC8791, IC8793, IC8794, IC8795, IC8796, IC8797, IC8798, IC8799, IC8800, IC8801, IC8802, IC8803, IC8804, IC8805, IC8806, IC8807, IC8808, IC8809, IC8810, IC8828, IC8829, IC8830, IC8831, IC8832, IC8833, IC8834, IC8835, IC8847, IC8848, IC8849, IC8850, IC8851, IC8852, IC8853, IC8862, IC8867, IC8878, IC8879, IC8881, IC8882, IC8883, IC8884, IC8885, IC8903, IC8904, IC8905, IC8906, IC8907, IC8908, IC8909, IC8925, IC8926, IC8928, IC8934, IC8935, IC8936, IC8938, IC8939, IC8940, IC8941, IC8942, IC8943, IC8944, IC8945, IC8946, IC8947, IC8948, IC8949, IC8950, IC8951, IC8952, IC8953, IC8954, IC8955, IC8956, IC8957, IC8958, IC8959, IC8960, IC8961, IC8962, IC8963, IC8964, IC8965, IC8966, IC8967, IC8968, IC8969, IC8970, IC8971, IC8972, IC8973, IC8974, IC8975, IC8976, IC8977, IC8978, IC8979, IC8981, IC8992, IC8993, IC8994, IC8995, IC8996, IC8997, IC8998, IC8999, IC9026, IC9029, IC9030, IC9032, IC9033, IC9034, IC9035, IC9037, IC9038, IC9040, IC9041, IC9042, IC9043, IC9044, IC9045, IC9046, IC9047, IC9048, IC9049, IC9068, IC9074, IC9079, IC9080, IC9081, IC9082, IC9083, IC9084, IC9086, IC9087, IC9088, IC9089, IC9097, IC9098, IC9099, IC9100, IC9101, IC9102, IC9103, IC9104, IC9116, IC9117, IC9118, IC9119, IC9120, IC9121, IC9122, IC9123, IC9124, IC9141, IC9142, IC9143, IC9144, IC9145, IC9146, IC9147, IC9148, IC9149, IC9150, IC9151, IC9152, IC9153, IC9154, IC9155, IC9156, IC9157, IC9158, IC9159, IC9160, IC9161, IC9162, IC9164, IC9165, IC9166, IC9184, IC9185, IC9186, IC9187, IC9188, IC9195, IC9196, IC9197, IC9198, IC9199, IC9204 , IC9205, IC9206, IC9207, IC9208, IC9209, IC9210, IC9211, IC9212, IC9213, IC9214, IC9218, IC9219, IC9220, IC9221, IC9222, IC9223, IC9224, IC9225, IC9226, IC9227, IC9231, IC9232, IC9243, IC9244, IC9245, IC9246, IC9247, IC9248, IC9249, IC9250, IC9266, IC9267, IC9268, IC9269, IC9270, IC9271, IC9272, IC9273, IC9274, IC9275, IC9276, IC9277, IC9278, IC9279, IC9280, IC9282, IC9283, IC9284, IC9285, IC9286, IC9287, IC9300, IC9301, IC9302, IC9303, IC9304, IC9305, IC9306, IC9307, IC9308, IC9309, IC9310, IC9311, IC9312, IC9313, IC9314, IC9315, IC9316, IC9317, IC9318, IC9319, IC9327, IC9333, IC9334, IC9335, IC9337, IC9338, IC9339, IC9350, IC9351, IC9353, IC9355, IC9357, IC9359, IC9360, IC9361, IC9362, IC9373, IC9374, IC9375, IC9376, IC9377, IC9378, IC9379, IC9380, IC9381, IC9382, IC9405, IC9406, IC9408, IC9409, IC9410, IC9412, IC9418, IC9421, IC9422, IC9423, IC9451, IC9452, IC9453, IC9454, IC9455, IC9456, IC9457, IC9458, IC9460, IC9461, IC9465, IC9466, IC9467, IC9468, IC9469, IC9470, IC9471, IC9472, IC9473, IC9474, IC9475, IC9476, IC9477, IC9478, IC9479, IC9480, IC9481, IC9482, IC9483, IC9484, IC9486, IC9488, IC9493, IC9510, IC9511, IC9512, IC9513, IC9514, IC9515, IC9516, IC9517, IC9518, IC9519, IC9520, IC9521, IC9522, IC9523, IC9524, IC9525, IC9526, IC9527, IC9528, IC9530, IC9532, IC9533, IC9534, IC9535, IC9536, IC9537, IC9538, IC9539, IC9541, IC9542, IC9543, IC9544, IC9545, IC9546, IC9547, IC9548, IC9549, IC9550, IC9551, IC9567, IC9571, IC9572, IC9573, IC9574, IC9575, IC9576, IC9577, IC9578, IC9579, IC9582, IC9583, IC9585, IC9586, IC9587, IC9588, IC9589, IC9594, IC9596, IC9597, IC9598, IC9606, IC9607, IC9608, IC9609, IC9611, IC9612, IC9613, IC9614, IC9617, IC9618, IC9619, IC9620, IC9621, IC9625, IC9649, IC9650, IC9651, IC9652, IC9653, IC9654, IC9655, IC9656, IC9657, IC9658, IC9659, IC9660, IC9661, IC9662, IC9663, IC9665, IC9666, IC9667, IC9668, IC9669, IC9670, IC9671, IC9672, IC9673, IC9675, IC9676, IC9677, IC9678, IC9679, IC9680, IC9681, IC9682, IC9683, IC9684, IC9685, IC9686, IC9688, IC9691, IC9697, IC9698, IC9699, IC9700, IC9701, IC9710, IC9711, IC9712, IC9713, IC9714, IC9715, IC9716, IC9717, IC9718, IC9719, IC9720, IC9721, IC9722, IC9723, IC9724, IC9725, IC9731, IC9733, IC9734, IC9735, IC9736, IC9737, IC9738, IC9739, IC9740, IC9741, IC9742, IC9743, IC9747, IC9748, IC9749, IC9750, IC9751, IC9752, IC9753, IC9754, IC9755, IC9756, IC9768, IC9769, IC9770, IC9771, IC9772, IC9774, IC9775, IC9776, IC9778, IC9779, IC9792, IC9794, IC9795, IC9806, IC9807, IC9808, IC9809, IC9810, IC9812, IC9823, IC9825, IC9826, IC9829, IC9831, IC9836, IC9837, IC9839, IC9840, IC9841, IC9842, IC9843, IC9844, IC9845, IC9846, IC9847, IC9848, IC9849, IC9850, IC9851, IC9852, IC9853, IC9854, IC9855, IC9856, IC9857, IC9858, IC9859, IC9860, IC9861, IC9862, IC9863, IC9864, IC9869, IC9870, IC9871, IC9872, IC9873, IC9874, IC9875, IC9876, IC9877, IC9878, IC9879, IC9880, IC9881, IC9882, IC9883, IC9884, IC9885, IC9886, IC9887, IC9888, IC9899, IC9900, IC9903, IC9904, IC9906, IC9907, IC9909, IC9910, IC9911, IC9912, IC9913, IC9914, IC9916, IC9917, IC9918, IC9920, IC9924, IC9932, IC9933, IC9934, IC9935, IC9936, IC9937, IC9938, IC9939, IC9940, IC9941, IC9963, IC9975, IC9976, IC9977, IC9978, IC9979, IC9980, IC9982, IC9983, IC9984, IC9985, IC9986, IC9987, IC9988, IC9991, IC9992, IC9993, IC9994, IC9995, IC9997, IC9999, IC11516, IC11819, IC12615, IC12627, IC13313, IC13315, IC13696, IC10547, IC10844, IC11055, IC11089, IC11091, IC11097, IC11151, IC11152, IC11494, IC12245, IC12248, IC13505, IC13560, IC13630, IC13633, IC8880, IC9036, IC9464;  7. Product Code: 0042-0040-KR; UDI-DI: 00813502013160; Serial Numbers: IC13611, IC13612, IC13613, IC13614, IC13615, IC13616, IC13722, IC13723, IC13724, IC13725;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3150-2026%22", "url": "https://recallledger.net/recalls/device-z-3150-2026-impella-optical-controller-automated-impella-controller-impella-conn/"}, {"id": "fda-device-z-3149-2026", "source": "FDA", "category": "device", "recall_number": "Z-3149-2026", "title": "Impella Optical Controller with the below product descriptions and corresponding... recall (Abiomed, Inc.)", "product": "Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.", "reason": "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.", "hazard_level": "Class I", "company": "Abiomed, Inc.", "company_location": "Danvers, MA, United States", "date": "2026-08-12", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: Nationwide Distribution.  International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;", "states": [], "nationwide": true, "quantity": "1422 units (487 US, 935 OUS)", "codes": "1. Impella Optical Controller, Packaged, AU;  Product Code: 0042-0010-AU; UDI-DI: 00813502010930; Serial Numbers: IC5130, IC5131;   2. Impella Optical Controller, Packaged, EU;  Product Code: 0042-0010-EU; UDI-DI: 00813502010961; Serial Numbers: IC12955, IC12978, IC13013, IC13027, IC13042, IC13202, IC13223, IC13228, IC6947, IC6948, IC7625, IC7740, IC7741, IC8064, IC8065, IC8157, IC8158, IC8419, IC8727, IC7937, IC7940, IC9356, IC9363, IC9365, IC9369, IC9370, IC9371, IC9832, IC9833, IC5409, IC7794, IC7795, IC7796, IC7798, IC7799, IC7800, IC7945, IC7946, IC8069, IC8070, IC8263, IC8337, IC8341, IC8343, IC8441, IC8445, IC8447, IC8448, IC8449, IC8451, IC8861, IC9025, IC9028, IC9366, IC9799, IC8476A, IC9181A, IC13190, IC13205, IC9031, IC9094, IC9801, IC9865, IC9867, IC9973, IC7825, IC9095, IC8032, IC8126, IC8629, IC8630, IC8640, IC8641, IC9364, IC9368, IC9804, IC9805, IC9834, IC9835, IC8388, IC8751, IC9501, IC9972, IC10035, IC7629, IC7636, IC8164, IC8683, IC5592, IC6277, IC7046, IC7637, IC7638, IC7639, IC7640, IC7762, IC7763, IC7764, IC7765, IC8013, IC8057, IC8058, IC8128, IC8130, IC8131, IC8132, IC8387, IC8401, IC8402, IC8560, IC8621, IC8623, IC8748, IC8750, IC8752, IC8763, IC8814, IC9092, IC9432, IC11485, IC12328, IC12329, IC12332, IC12334, IC12346, IC13037, IC13038, IC8714, IC8775, IC8812, IC9005A, IC9006A, IC9008, IC9093, IC9096, IC9299, IC9783, IC9784, IC9961, IC7231, IC5037, IC5038, IC11162, IC11498, IC12326, IC12984, IC13239, IC13797, IC8488, IC8494, IC8503, IC8514, IC8588, IC8589, IC8642, IC8646, IC11691, IC4946, IC4947, IC4948, IC4949, IC4950, IC4951, IC4952, IC4953, IC4954, IC4955, IC4957, IC4958, IC4959, IC4960, IC4961, IC5039, IC5040, IC5041, IC5044, IC5045, IC5076, IC5077, IC5078, IC5079, IC5080, IC5081, IC5082, IC5084, IC5085, IC5096, IC5097, IC5098, IC5099, IC5100, IC5101, IC5102, IC5103, IC5104, IC5105, IC5106, IC5107, IC5108, IC5109, IC5110, IC5111, IC5112, IC5113, IC5114, IC5115, IC5126, IC5127, IC5128, IC5132, IC5133, IC5134, IC5135, IC5136, IC5137, IC5138, IC5139, IC5140, IC5141, IC5142, IC5143, IC5144, IC5145, IC5156, IC5157, IC5158, IC5159, IC5160, IC5161, IC5162, IC5163, IC5164, IC5233, IC5234, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5281, IC5283, IC5284, IC5285, IC5350, IC5355, IC5376, IC5377, IC5378, IC5383, IC5396, IC5397, IC5399, IC5400, IC5401, IC5402, IC5403, IC5404, IC5407, IC5408, IC5410, IC5411, IC5412, IC5413, IC5414, IC5415, IC5526, IC5527, IC5528, IC5529, IC5530, IC5531, IC5532, IC5533, IC5534, IC5535, IC5566, IC5567, IC5568, IC5569, IC5570, IC5571, IC5572, IC5573, IC5574, IC5575, IC5576, IC5577, IC5578, IC5579, IC5581, IC5582, IC5583, IC5584, IC5585, IC5586, IC5587, IC5588, IC5589, IC5590, IC5591, IC5594, IC5595, IC5626, IC5627, IC5628, IC5629, IC5630, IC5631, IC5632, IC5633, IC5634, IC5635, IC5636, IC5638, IC5639, IC5640, IC5641, IC5642, IC5643, IC5644, IC5645, IC5666, IC5667, IC5668, IC5669, IC5671, IC5672, IC5801, IC5802, IC5803, IC5804, IC5805, IC5806, IC5807, IC5808, IC5809, IC5810, IC5811, IC5812, IC5813, IC5814, IC5896, IC5897, IC5898, IC5899, IC5900, IC5902, IC5903, IC5904, IC5905, IC5916, IC5918, IC5920, IC5921, IC5922, IC5923, IC5924, IC5925, IC5963, IC5964, IC5965, IC5966, IC5967, IC5968, IC6012, IC6013, IC6014, IC6015, IC6016, IC6017, IC6018, IC6019, IC6020, IC6021, IC6022, IC6023, IC6024, IC6025, IC6067, IC6068, IC6069, IC6070, IC6073, IC6074, IC6075, IC6116, IC6117, IC6120, IC6121, IC6122, IC6123, IC6124, IC6166, IC6167, IC6168, IC6169, IC6171, IC6172, IC6173, IC6174, IC6175, IC6226, IC6229, IC6230, IC6231, IC6232, IC6234, IC6235, IC6256, IC6257, IC6258, IC6259, IC6260, IC6265, IC6276, IC6278, IC6279, IC6280, IC6281, IC6282, IC6283, IC6297, IC6298, IC6299, IC6302, IC6303, IC6304, IC6305, IC6336, IC6337, IC6338, IC6339, IC6340, IC6341, IC6342, IC6343, IC6344, IC6345, IC6376, IC6377, IC6378, IC6379, IC6383, IC6384, IC6416, IC6417, IC6418, IC6421, IC6422, IC6460, IC6461, IC6462, IC6463, IC6465, IC6698, IC6703, IC6758, IC6776, IC6777, IC6779, IC6780, IC6781, IC6784, IC6785, IC6788, IC6789, IC6790, IC6791, IC6792, IC6793, IC6794, IC6795, IC6866, IC6867, IC6868, IC6869, IC6870, IC6871, IC6872, IC6873, IC6874, IC6875, IC6936, IC6937, IC6938, IC6939, IC6940, IC6941, IC6942, IC6943, IC6944, IC6945, IC6946, IC6949, IC6950, IC6951, IC6952, IC6954, IC6955, IC6986, IC6987, IC6988, IC7047, IC7048, IC7049, IC7050, IC7051, IC7052, IC7053, IC7054, IC7055, IC7156, IC7157, IC7158, IC7159, IC7160, IC7161, IC7163, IC7164, IC7226, IC7227, IC7232, IC7233, IC7234, IC7235, IC7266, IC7267, IC7268, IC7269, IC7270, IC7271, IC7272, IC7273, IC7274, IC7275, IC7356, IC7357, IC7358, IC7359, IC7360, IC7361, IC7362, IC7363, IC7364, IC7457, IC7458, IC7459, IC7460, IC7461, IC7462, IC7463, IC7464, IC7465, IC7523, IC7524, IC7525, IC7526, IC7528, IC7586, IC7587, IC7588, IC7589, IC7590, IC7620, IC7621, IC7622, IC7623, IC7624, IC7626, IC7627, IC7628, IC7710, IC7711, IC7738, IC7739, IC7792, IC7793, IC7821, IC7822, IC7823, IC7824, IC7826, IC7829, IC7830, IC7860, IC7863, IC7864, IC7865, IC7866, IC7867, IC7868, IC7869, IC7920, IC7939, IC7943, IC7944, IC7947, IC7953, IC7956, IC7958, IC7964, IC7965, IC8011, IC8012, IC8059, IC8060, IC8061, IC8063, IC8067, IC8068, IC8071, IC8073, IC8074, IC8075, IC8117, IC8118, IC8119, IC8122, IC8123, IC8124, IC8125, IC8145, IC8146, IC8159, IC8160, IC8161, IC8165, IC8201, IC8202, IC8203, IC8204, IC8205, IC8206, IC8217, IC8218, IC8219, IC8220, IC8221, IC8226, IC8252, IC8253, IC8254, IC8255, IC8256, IC8257, IC8258, IC8259, IC8260, IC8261, IC8262, IC8336, IC8340, IC8342, IC8344, IC8345, IC8395, IC8396, IC8397, IC8400, IC8403, IC8405, IC8421, IC8422, IC8423, IC8424, IC8439, IC8443, IC8444, IC8450, IC8457, IC8482, IC8486, IC8487, IC8499, IC8511, IC8512, IC8584, IC8586, IC8591, IC8592, IC8600, IC8610, IC8622, IC8625, IC8639, IC8643, IC8644, IC8645, IC8647, IC8648, IC8649, IC8661, IC8662, IC8663, IC8664, IC8690, IC8691, IC8693, IC8696, IC8723, IC8725, IC8726, IC8729, IC8737, IC8739, IC8931, IC8338, IC8339, IC8596, IC8608, IC8655, IC8665, IC8692, IC8761, IC8762, IC8813, IC9349, IC9372, IC7827, IC7828, IC8133, IC8134, IC9385, IC8404, IC8420, IC11746, IC12327, IC12344, IC13040, IC8425, IC8426, IC8427, IC8428, IC7861, IC7862, IC7954, IC7957, IC8120, IC8121, IC8222, IC8225, IC9027, IC9090, IC9091, IC8062, IC8066, IC5042, IC5129, IC5282, IC5580, IC5919, IC6118, IC6119, IC6261, IC6263, IC6459, IC7456, IC7529, IC7797, IC7941, IC7942, IC7955, IC8147, IC8442, IC8495, IC8513, IC8590, IC8753, IC8754, IC8755, IC8764, IC8765, IC9085, IC9230, IC9367, IC8875, IC9383, IC9796, IC9866, IC9974, IC10023, IC10024, IC9996, IC9998, IC11491, IC11451, IC11456, IC11497, IC11500, IC11741, IC11742, IC11745, IC11747, IC11748, IC11749;  3. Impella Optical Controller, Packaged, IN;  Product Code: 0042-0010-IN; UDI-DI: 00813502011425; Serial Numbers: IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8609, IC8980, IC9177, IC9178, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970;  4. Impella Optical Controller, Packaged, UK;  Product Code: 0042-0010-UK; UDI-DI: 00813502010978; Serial Numbers: IC8105, IC8106, IC8308, IC8315, IC8316, IC8335, IC8541, IC8542, IC8543, IC8895, IC9163, IC10013, IC10014, IC11023, IC11183, IC11442, IC12507, IC9133, IC9443, IC10012, IC10015, IC10039, IC10044, IC10319, IC10320, IC10640, IC10641, IC10645, IC10646, IC10648, IC10649, IC11019, IC11026, IC11027, IC11028, IC11048, IC11071, IC11086, IC11190, IC11201, IC11202, IC11441, IC11444, IC11445, IC11448, IC12503, IC12504, IC12579, IC12580, IC12581, IC12582, IC12719, IC12720, IC12721, IC12723, IC13159, IC13201, IC13204, IC13219, IC13220, IC13221, IC13278, IC13279, IC13280, IC8334, IC8767, IC8768, IC8774, IC9441, IC9445, IC9599, IC10040, IC10043, IC10808, IC11186, IC11211, IC11440, IC12505, IC12506, IC8101, IC8102, IC8103, IC8104, IC8544, IC9446, IC9449, IC8113, IC8114, IC8115, IC8116, IC8127, IC8129, IC8297, IC8331, IC8332, IC8333, IC8561, IC8563, IC8593, IC8594, IC9442, IC9444, IC9447, IC9448, IC9450, IC8295;  5. Impella Optical Controller, Packaged, US;  Product Code: 0042-0010-US; UDI-DI: 00813502010985; Serial Numbers: IC11685, IC5970, IC5971, IC6956, IC6957, IC6958, IC6959, IC6960, IC6961, IC6962, IC6963, IC6964, IC6965, IC6966, IC6967, IC6968, IC6969, IC6970, IC6971, IC6972, IC6973, IC6974, IC6975, IC6996, IC6997, IC6998, IC6999, IC7000, IC7001, IC7002, IC7003, IC7004, IC7005, IC7006, IC7007, IC7009, IC7011, IC7012, IC7013, IC7014, IC7015, IC7016, IC7017, IC7018, IC7019, IC7020, IC7021, IC7022, IC7023, IC7024, IC7025, IC7036, IC7037, IC7038, IC7109, IC7110, IC7111, IC7112, IC7113, IC7114, IC7115, IC7116, IC7117, IC7118, IC7119, IC7120, IC7123, IC7125, IC7127, IC7128, IC7129, IC7130, IC7131, IC7132, IC7135, IC7136, IC7137, IC7138, IC7139, IC7150, IC7151, IC7152, IC7153, IC7154, IC7155, IC7166, IC7167, IC7168, IC7169, IC7170, IC7171, IC7172, IC7173, IC7174, IC7175, IC7176, IC7177, IC7178, IC7179, IC7192, IC7193, IC7194, IC7195, IC7196, IC7197, IC7198, IC7199, IC7200, IC7201, IC7202, IC7203, IC7204, IC7205, IC7206, IC7208, IC7209, IC7210, IC7211, IC7212, IC7213, IC7214, IC7215, IC7216, IC7217, IC7222, IC7223, IC7224, IC7225, IC7236, IC7237, IC7238, IC7239, IC7240, IC7241, IC7243, IC7244, IC7245, IC7246, IC7247, IC7249, IC7250, IC7251, IC7252, IC7253, IC7254, IC7255, IC7276, IC7277, IC7278, IC7279, IC7280, IC7281, IC7282, IC7283, IC7284, IC7285, IC7296, IC7297, IC7298, IC7299, IC7300, IC7301, IC7302, IC7303, IC7304, IC7305, IC7306, IC7307, IC7308, IC7313, IC7315, IC7316, IC7317, IC7318, IC7319, IC7320, IC7321, IC7322, IC7324, IC7325, IC7326, IC7327, IC7328, IC7329, IC7330, IC7331, IC7332, IC7333, IC7334, IC7335, IC7336, IC7337, IC7338, IC7344, IC7345, IC7346, IC7347, IC7348, IC7349, IC7350, IC7351, IC7352, IC7353, IC7354, IC7355, IC7366, IC7367, IC7368, IC7369, IC7370, IC7371, IC7372, IC7373, IC7374, IC7375, IC7396, IC7397, IC7398, IC7399, IC7400, IC7401, IC7402, IC7403, IC7404, IC7405, IC7466, IC7467, IC7468, IC7469, IC7470, IC7471, IC7472, IC7473, IC7474, IC7476, IC7477, IC7478, IC7479, IC7480, IC7481, IC7482, IC7483, IC7484, IC7485, IC7486, IC7487, IC7488, IC7489, IC7490, IC7491, IC7492, IC7493, IC7494, IC7495, IC7496, IC7497, IC7498, IC7499, IC7500, IC7501, IC7502, IC7503, IC7504, IC7505, IC7506, IC7507, IC7508, IC7509, IC7510, IC7511, IC7512, IC7513, IC7514, IC7515, IC7516, IC7517, IC7518, IC7534, IC7535, IC7536, IC7537, IC7538, IC7539, IC7540, IC7541, IC7542, IC7543, IC7544, IC7545, IC7547, IC7548, IC7549, IC7550, IC7551, IC7552, IC7553, IC7554, IC7555, IC7556, IC7557, IC7558, IC7559, IC7561, IC7564, IC7570, IC7573, IC7574, IC7599, IC7600, IC7601, IC7602, IC7603, IC7604, IC7605, IC7616, IC7617, IC7618, IC7619, IC7658, IC7659, IC7660, IC7661, IC7662, IC7663, IC7664, IC7665, IC7676, IC7677, IC7678, IC7679, IC7699, IC7700, IC7701, IC7702, IC7703, IC7704, IC7705, IC7706, IC7707, IC7712, IC7713, IC7714, IC7715, IC7726, IC7727, IC7728, IC7729, IC7730, IC7731, IC7732, IC7733, IC7734, IC7735, IC7736, IC7737, IC7742, IC7743, IC7744, IC7745, IC7756, IC7757, IC7758, IC7759, IC7760, IC7761, IC7771, IC7772, IC7773, IC7774, IC7775, IC7786, IC7787, IC7788, IC7789, IC7790, IC7791, IC7802, IC7803, IC7804, IC7805, IC7816, IC7817, IC7818, IC7819, IC7820, IC7877, IC7878, IC7879, IC7880, IC7882, IC7883, IC7884, IC7890, IC7893, IC7894, IC7906, IC7908, IC7974, IC8002, IC8003, IC8004, IC8006, IC8008, IC8026, IC8029, IC8034, IC8035, IC8037, IC8040, IC8041, IC10049, IC10066, IC10587, IC9228, IC9229, IC9610, IC9622, IC9773, IC9780, IC9781, IC9782, IC10102, IC10103, IC10318, IC10463, IC10589, IC10979, IC11299, IC12316, IC12758, IC12859, IC12900, IC13812, IC9989, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC11656, IC11670, IC11674, IC11677, IC12214, IC12279, IC12414, IC12415, IC12417, IC12418, IC12419, IC12820, IC12857, IC12858, IC12870, IC12885, IC12973, IC12974, IC13231, IC13263, IC13264, IC13265, IC13268, IC13270, IC13271, IC13681, IC13682, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC7010, IC12884, IC12953, IC13232, IC13698, IC12968, IC13212, IC13269, IC13862;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3149-2026%22", "url": "https://recallledger.net/recalls/device-z-3149-2026-impella-optical-controller-with-the-below-product-descriptions-and-cor/"}, {"id": "fda-device-z-3148-2026", "source": "FDA", "category": "device", "recall_number": "Z-3148-2026", "title": "Automated Impella Controller recall (Abiomed, Inc.)", "product": "Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.", "reason": "The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.", "hazard_level": "Class I", "company": "Abiomed, Inc.", "company_location": "Danvers, MA, United States", "date": "2026-08-12", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "Domestic: Nationwide Distribution.  International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;", "states": [], "nationwide": true, "quantity": "5232 units (3733 US, 1499 OUS) 36 3", "codes": "1. Impella Controller, Packaged, CA;  Product Code: 0042-0000-CA; UDI-DI: 00813502010022; Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715, IC1769, IC1790, IC1791, IC1911, IC1912, IC1913, IC2032, IC2033, IC2034, IC2035, IC2369, IC2370, IC2686, IC2687, IC3661, IC3662, IC3802, IC3803, IC4944, IC4945, IC5034, IC5050, IC5680, IC5821, IC5824, IC6082, IC6083, IC6633, IC6634, IC6635, IC6636, IC7694, IC7695, IC7716, IC8283, IC9413, IC9414, IC9415, IC9416;  2. Impella Controller, Packaged, EU;  Product Code: 0042-0000-EU; UDI-DI: 00813502011289; Serial Numbers: IC1347, IC1349, IC6845, IC1285, IC1416, IC2765, IC2766, IC3021, IC3022, IC3718, IC3719, IC3720, IC3776, IC5558, IC5559, IC1578, IC1585, IC1902, IC1903, IC1905, IC2678, IC2679, IC2855, IC2856, IC3053, IC3054, IC3329, IC3671, IC3672, IC3830, IC3831, IC4033, IC4837, IC5086, IC5169, IC5171, IC5560, IC5681, IC5682, IC5683, IC6064, IC6081, IC6149, IC6270, IC6272, IC6437, IC6439, IC6441, IC6443, IC6810, IC6812, IC6813, IC6814, IC7261, IC7262, IC7393, IC7394, IC7576, IC7577, IC7646, IC1825, IC1826, IC1870, IC1876, IC4153, IC4175, IC4657, IC4658, IC5476, IC5477, IC5518, IC5520, IC7263, IC7264, IC1011, IC1490, IC1584, IC1590, IC1592, IC2175, IC2176, IC2857, IC2996, IC2997, IC3291, IC3296, IC3317, IC3318, IC3486, IC3488, IC3698, IC3702, IC3724, IC3778, IC3864, IC3870, IC3890, IC3891, IC4151, IC4152, IC4323, IC4324, IC4471, IC4501, IC4681, IC4682, IC4851, IC4892, IC4933, IC4934, IC4973, IC4984, IC4986, IC4987, IC4988, IC5007, IC5048, IC5175, IC5176, IC5195, IC5421, IC5422, IC5433, IC5434, IC5441, IC5442, IC5460, IC5461, IC5463, IC5464, IC5494, IC5495, IC5496, IC5519, IC5611, IC5684, IC5687, IC5688, IC5714, IC5722, IC5818, IC6065, IC6534, IC6535, IC6536, IC6582, IC6587, IC6588, IC6589, IC6590, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6876, IC6877, IC6878, IC6879, IC7388, IC7389, IC7390, IC7392, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC1284, IC2676, IC2677, IC2710, IC2827, IC2828, IC2989, IC3018, IC3020, IC3471, IC5775, IC5777, IC5779, IC5780, IC2099, IC2205, IC2220, IC2654, IC2655, IC2823, IC2824, IC2825, IC2826, IC3668, IC3670, IC3868, IC3869, IC4099, IC4100, IC4209, IC4218, IC4325, IC4326, IC4569, IC4611, IC4624, IC4627, IC4931, IC4932, IC5490, IC5491, IC5492, IC5493, IC6205, IC6275, IC6331, IC6432, IC6434, IC6435, IC6880, IC7407, IC7421, IC7455, IC7675, IC7686, IC7691, IC7692, IC7693, IC7717, IC7720, IC7721, IC7748, IC7809, IC3131, IC3132, IC1549, IC1580, IC2234, IC2236, IC2469, IC2652, IC2653, IC3069, IC3070, IC3311, IC3331, IC3332, IC3657, IC3669, IC3777, IC3828, IC3829, IC4150, IC1396, IC1397, IC1413, IC1415, IC1546, IC1548, IC1724, IC1725, IC1767, IC1768, IC2235, IC2239, IC2483, IC2486, IC2836, IC2838, IC3050, IC3673, IC3696, IC3697, IC4565, IC4839, IC5755, IC5756, IC6487, IC6488, IC7667, IC7674, IC7689, IC7690, IC3301, IC3302, IC1301, IC1302, IC1304, IC1305, IC1217, IC1276, IC1384, IC1386, IC1395, IC1522, IC1523, IC1547, IC1577, IC1579, IC1594, IC1676, IC1684, IC1699, IC1700, IC1722, IC1723, IC1764, IC1821, IC1824, IC1886, IC1974, IC2101, IC2102, IC2329, IC2862, IC2873, IC2874, IC2875, IC2876, IC2877, IC4002, IC4012, IC4013, IC4014, IC4015, IC4464, IC4465, IC4470, IC4566, IC4597, IC4598, IC4609, IC4623, IC4634, IC4635, IC4636, IC4645, IC4656, IC4833, IC4834, IC4835, IC4836, IC4850, IC4852, IC4928, IC4929, IC4930, IC5051, IC5053, IC5057, IC5075, IC5685, IC6579, IC6591, IC6592, IC6593, IC6594, IC6595, IC6708, IC6709, IC6711, IC6715, IC6716, IC6717, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC7098, IC7099, IC7100, IC7258, IC7259, IC7260, IC7580, IC7613, IC7614, IC7615, IC7687, IC7688, IC3817, IC3818, IC5008, IC5009, IC5046, IC5047, IC6223, IC6224, IC7286, IC7378, IC7087, IC7092, IC1265, IC1275, IC1280, IC1283, IC1288, IC1344, IC1345, IC1350, IC1383, IC1411, IC1653, IC1726, IC1761, IC1775, IC1780, IC1881, IC1901, IC1904, IC1907, IC1908, IC1971, IC1972, IC1973, IC1975, IC1976, IC1977, IC1978, IC2005, IC2006, IC2038, IC2039, IC2095, IC2096, IC2098, IC2171, IC2172, IC2173, IC2174, IC2204, IC2207, IC2231, IC2232, IC2233, IC2240, IC2241, IC2242, IC2243, IC2266, IC2267, IC2268, IC2325, IC2326, IC2327, IC2330, IC2332, IC2411, IC2412, IC2413, IC2414, IC2441, IC2473, IC2474, IC2475, IC2481, IC2484, IC2485, IC2490, IC2491, IC2494, IC2512, IC2534, IC2556, IC2557, IC2607, IC2609, IC2610, IC2658, IC2659, IC2670, IC2708, IC2712, IC2752, IC2757, IC2758, IC2763, IC2767, IC2829, IC2830, IC2858, IC2859, IC2878, IC2960, IC2962, IC2964, IC2984, IC2985, IC2987, IC2988, IC3017, IC3019, IC3051, IC3052, IC3067, IC3068, IC3095, IC3096, IC3099, IC3100, IC3101, IC3102, IC3133, IC3134, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3178, IC3179, IC3180, IC3181, IC3286, IC3287, IC3288, IC3289, IC3290, IC3292, IC3297, IC3298, IC3299, IC3300, IC3303, IC3304, IC3305, IC3310, IC3313, IC3314, IC3315, IC3316, IC3319, IC3321, IC3322, IC3323, IC3324, IC3327, IC3328, IC3330, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3466, IC3467, IC3468, IC3472, IC3477, IC3484, IC3485, IC3490, IC3492, IC3493, IC3495, IC3659, IC3660, IC3667, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3717, IC3781, IC3782, IC3813, IC3814, IC3815, IC3816, IC3832, IC3833, IC3834, IC3859, IC3860, IC3861, IC3862, IC3863, IC3871, IC3872, IC3873, IC3884, IC3885, IC3886, IC3889, IC4034, IC4035, IC4036, IC4037, IC4083, IC4096, IC4097, IC4098, IC4128, IC4129, IC4146, IC4147, IC4148, IC4149, IC4207, IC4208, IC4210, IC4211, IC4212, IC4217, IC4227, IC4228, IC4229, IC4230, IC4234, IC4235, IC4236, IC4238, IC4240, IC4241, IC4242, IC4251, IC4252, IC4253, IC4258, IC4322, IC4328, IC4356, IC4357, IC4359, IC4360, IC4361, IC4362, IC4363, IC4365, IC4366, IC4367, IC4370, IC4371, IC4442, IC4443, IC4444, IC4445, IC4446, IC4466, IC4467, IC4468, IC4469, IC4500, IC4505, IC4506, IC4557, IC4559, IC4560, IC4561, IC4564, IC4567, IC4568, IC4585, IC4594, IC4595, IC4610, IC4612, IC4613, IC4614, IC4626, IC4629, IC4630, IC4631, IC4632, IC4633, IC4646, IC4647, IC4677, IC4678, IC4725, IC4727, IC4728, IC4729, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4781, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4823, IC4824, IC4840, IC4845, IC4848, IC4869, IC4875, IC5177, IC5517, IC1340, IC1488, IC1586, IC1588, IC1591, IC1677, IC2097, IC2100, IC2178, IC2179, IC2206, IC2244, IC2560, IC2606, IC2656, IC2668, IC2669, IC2709, IC2751, IC2837, IC3015, IC3048, IC3049, IC3097, IC3098, IC3182, IC3183, IC3487, IC3489, IC3491, IC3494, IC3780, IC3866, IC3867, IC4081, IC4329, IC4358, IC4562, IC4563, IC4648, IC4649, IC4723, IC4724, IC4790, IC4791, IC4912, IC4913, IC4915, IC4917, IC5174, IC5356, IC5443, IC5462, IC5686, IC5757, IC5774, IC6078, IC6079, IC6080, IC6147, IC6273, IC6274, IC6431, IC6580, IC6581, IC7077, IC7078, IC7718, IC7719, IC1872, IC1874, IC3704, IC3705, IC5049, IC5055, IC1341, IC1343, IC1381, IC1393, IC1685, IC1720, IC1727, IC1763, IC1765, IC1766, IC2470, IC2472, IC5178, IC5193, IC5194, IC5435, IC5436, IC5440, IC5715, IC5716, IC5717, IC5754, IC6225, IC6236, IC7653, IC7654, IC2442, IC2443, IC2444, IC2471, IC2476, IC2477, IC2478, IC2479, IC3127, IC3128, IC3129, IC3130, IC3306, IC3307, IC3308, IC3309, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3783, IC3812, IC3887, IC3888, IC4068, IC4069, IC4254, IC4255, IC4256, IC4257, IC4507, IC4508, IC5087, IC5088, IC5210, IC5212, IC5251, IC5252, IC5357, IC5391, IC5392, IC5465, IC5466, IC5467, IC6164, IC6165, IC6214, IC6216, IC6293, IC6294, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6510, IC7452, IC7453, IC7454, IC7581, IC7582, IC7583, IC7584, IC3469, IC3470, IC5487, IC5488, IC6449, IC6469, IC6577, IC6578, IC6710, IC6712, IC7093, IC7094, IC7095, IC7096, IC7097, IC7265, IC7395, IC7406, IC7578, IC7579, IC7655, IC7666, IC2961, IC2963, IC3699, IC3700, IC4679, IC4680, IC4914, IC4916, IC5781, IC5817, IC6150, IC6151, IC6436, IC6440, IC6713, IC6714, IC6843, IC7075, IC7076, IC7810, IC1398, IC1524, IC1587, IC1593, IC1678, IC1721, IC1822, IC2021, IC2040, IC2221, IC2222, IC2245, IC2331, IC2380, IC2657, IC2835, IC3016, IC3874, IC3875, IC4055, IC4231, IC4232, IC4233, IC4237, IC4502, IC4503, IC4628, IC4846, IC4911, IC5173, IC5331, IC5489, IC6076, IC6148, IC6474, IC6844;  3. 1. Impella Controller, Packaged, IN;  Product Code: 0042-0000-IN; UDI-DI: 00813502011418; Serial Numbers: IC6139, IC6252, IC6253, IC6254, IC6475, IC6476, IC6477, IC6478, IC7079, IC7080, IC7408, IC7409, IC7410, IC7411;  4. Impella Controller, Packaged, JP;  Product Code: 0042-0000-JP; UDI-DI: 00813502010428; Serial Numbers: IC4732, IC5027, IC5241, IC5243, IC5245, IC5259, IC5260, IC5261, IC5444, IC5445, IC5447, IC5478, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5864, IC5865, IC5866, IC5867, IC5868, IC5930, IC5935, IC5936, IC5937, IC5938, IC6046, IC6047, IC6048, IC6049, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6203, IC6204, IC6210, IC6211, IC6212, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6388, IC6389, IC6405, IC6406, IC6407, IC6429, IC6430, IC6442, IC6451, IC6452, IC6466, IC6467, IC6468, IC6490, IC6491, IC6492, IC6519, IC6533, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6605, IC6606, IC6607, IC6610, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6662, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7291, IC7293, IC7294, IC7295, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7433, IC7434, IC7435, IC7439, IC7440, IC7450, IC7451, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7672, IC7673, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7779, IC7782, IC7783, IC7784, IC7785, IC7806, IC7808, IC7811, IC7812, IC7813, IC7814, IC7815, IC7846, IC7852, IC7853, IC7896, IC7897, IC7898, IC7899, IC7900, IC7901, IC7902, IC7903, IC7905, IC7926, IC7927, IC7929, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC8047, IC8048, IC8049, IC8050, IC8051, IC8053, IC8054, IC8076, IC8077, IC8078, IC8079, IC8080, IC8081, IC8082, IC8083, IC8084, IC8276, IC8277, IC8278, IC8279, IC8281;   5. Impella Controller, Packaged, UK;  Product Code: 0042-0000-UK; UDI-DI: 00813502011296; Serial Numbers: IC1387, IC1389, IC1519, IC1542, IC1573, IC1792, IC1868, IC1869, IC1909, IC2277, IC2278, IC2493, IC2497, IC2871, IC2872, IC3293, IC3294, IC3295, IC3674, IC3675, IC3784, IC3785, IC4439, IC4440, IC4721, IC4722, IC4739, IC4741, IC4841, IC4842, IC5179, IC5181, IC5219, IC5220, IC5247, IC5553, IC5554, IC5555, IC5831, IC5832, IC5911, IC5912, IC5926, IC5927, IC6286, IC6287, IC6289, IC6290, IC6537, IC6538, IC6540, IC6583, IC6584, IC6585, IC6586, IC6925, IC7056, IC7057, IC7069, IC7070, IC7071, IC7073, IC7074, IC7441, IC7591, IC3326, IC3333, IC3334, IC3464, IC3465, IC3474, IC4599, IC4600, IC5914, IC5915, IC6542, IC6543, IC7776, IC7777, IC5254, IC5833, IC7444, IC7445, IC7446, IC7447, IC1388, IC1545, IC1581, IC1582, IC1583, IC2367, IC2368, IC2492, IC2496, IC4166, IC4330, IC4331, IC4438, IC4843, IC4844, IC4856, IC4857, IC5180, IC5211, IC1910, IC2023, IC2704, IC2705, IC2706, IC2707, IC3312, IC3325, IC4675, IC4676, IC6924, IC6934, IC2024, IC2025, IC5182, IC5184, IC5213, IC5218, IC6291, IC6292, IC7443, IC7585, IC5995, IC5996, IC5997, IC5998, IC5999, IC6001, IC3174, IC3475, IC4441, IC4525, IC5214, IC5215, IC5253, IC5557, IC5830, IC5910, IC6638, IC6669, IC6670, IC6671, IC7668, IC7669, IC7670, IC7671, IC7847, IC7848, IC7778, IC4926, IC4927, IC1494, IC4082, IC7442;   6. Impella Controller, Packaged, US;  Product Code: 0042-0000-US; UDI-DI: 00813502010022; Serial Numbers: IC1004, IC1006, IC1007, IC1008, IC1014, IC1015, IC1017, IC1019, IC1024, IC1025, IC1026, IC1027, IC1028, IC1029, IC1030, IC1031, IC1032, IC1033, IC1035, IC1036, IC1037, IC1038, IC1039, IC1040, IC1041, IC1042, IC1043, IC1044, IC1046, IC1047, IC1049, IC1050, IC1051, IC1052, IC1053, IC1055, IC1056, IC1058, IC1060, IC1061, IC1062, IC1064, IC1065, IC1066, IC1067, IC1068, IC1069, IC1070, IC1071, IC1072, IC1073, IC1074, IC1075, IC1076, IC1077, IC1078, IC1079, IC1080, IC1081, IC1082, IC1083, IC1084, IC1085, IC1086, IC1087, IC1088, IC1089, IC1093, IC1094, IC1095, IC1096, IC1097, IC1100, IC1102, IC1103, IC1104, IC1105, IC1106, IC1108, IC1110, IC1111, IC1112, IC1114, IC1115, IC1116, IC1117, IC1119, IC1120, IC1121, IC1122, IC1123, IC1124, IC1132, IC1133, IC1134, IC1135, IC1136, IC1137, IC1138, IC1139, IC1141, IC1142, IC1143, IC1144, IC1145, IC1146, IC1147, IC1148, IC1149, IC1150, IC1151, IC1152, IC1153, IC1154, IC1155, IC1156, IC1157, IC1158, IC1159, IC1160, IC1161, IC1162, IC1163, IC1164, IC1165, IC1166, IC1167, IC1168, IC1169, IC1170, IC1171, IC1172, IC1173, IC1174, IC1175, IC1176, IC1177, IC1178, IC1180, IC1181, IC1182, IC1183, IC1184, IC1185, IC1186, IC1187, IC1188, IC1189, IC1190, IC1191, IC1192, IC1193, IC1194, IC1196, IC1197, IC1198, IC1199, IC1200, IC1201, IC1202, IC1203, IC1204, IC1205, IC1206, IC1207, IC1209, IC1211, IC1212, IC1213, IC1214, IC1215, IC1218, IC1219, IC1220, IC1221, IC1222, IC1223, IC1224, IC1225, IC1226, IC1227, IC1228, IC1229, IC1230, IC1231, IC1233, IC1234, IC1235, IC1236, IC1237, IC1238, IC1239, IC1240, IC1242, IC1243, IC1244, IC1245, IC1246, IC1247, IC1250, IC1251, IC1252, IC1253, IC1254, IC1255, IC1256, IC1257, IC1258, IC1259, IC1261, IC1262, IC1263, IC1264, IC1269, IC1270, IC1271, IC1272, IC1273, IC1274, IC1289, IC1290, IC1291, IC1292, IC1293, IC1294, IC1295, IC1296, IC1297, IC1298, IC1299, IC1300, IC1306, IC1307, IC1309, IC1310, IC1311, IC1312, IC1313, IC1314, IC1315, IC1316, IC1317, IC1319, IC1320, IC1321, IC1322, IC1323, IC1325, IC1326, IC1327, IC1328, IC1329, IC1330, IC1331, IC1332, IC1333, IC1334, IC1335, IC1336, IC1337, IC1338, IC1339, IC1342, IC1351, IC1352, IC1353, IC1354, IC1355, IC1356, IC1357, IC1358, IC1359, IC1360, IC1361, IC1362, IC1363, IC1364, IC1365, IC1368, IC1372, IC1373, IC1374, IC1375, IC1376, IC1377, IC1378, IC1379, IC1380, IC1382, IC1390, IC1394, IC1400, IC1401, IC1402, IC1403, IC1404, IC1405, IC1406, IC1407, IC1408, IC1409, IC1410, IC1412, IC1414, IC1417, IC1418, IC1419, IC1420, IC1421, IC1422, IC1423, IC1424, IC1425, IC1426, IC1427, IC1428, IC1429, IC1430, IC1431, IC1432, IC1433, IC1434, IC1435, IC1436, IC1437, IC1438, IC1439, IC1440, IC1441, IC1442, IC1443, IC1444, IC1445, IC1446, IC1448, IC1449, IC1450, IC1451, IC1452, IC1453, IC1454, IC1455, IC1456, IC1457, IC1458, IC1459, IC1460, IC1461, IC1462, IC1463, IC1464, IC1466, IC1467, IC1469, IC1470, IC1471, IC1472, IC1473, IC1474, IC1475, IC1476, IC1477, IC1478, IC1479, IC1483, IC1484, IC1485, IC1486, IC1489, IC1491, IC1492, IC1495, IC1496, IC1497, IC1498, IC1499, IC1500, IC1502, IC1503, IC1504, IC1505, IC1506, IC1507, IC1508, IC1509, IC1510, IC1512, IC1513, IC1514, IC1515, IC1516, IC1517, IC1518, IC1526, IC1527, IC1528, IC1529, IC1530, IC1531, IC1532, IC1533, IC1534, IC1535, IC1536, IC1537, IC1538, IC1539, IC1540, IC1541, IC1550, IC1551, IC1552, IC1553, IC1554, IC1555, IC1556, IC1557, IC1558, IC1559, IC1560, IC1561, IC1562, IC1563, IC1564, IC1565, IC1566, IC1567, IC1568, IC1569, IC1570, IC1571, IC1574, IC1575, IC1596, IC1599, IC1600, IC1601, IC1602, IC1603, IC1604, IC1605, IC1606, IC1607, IC1608, IC1609, IC1610, IC1612, IC1613, IC1614, IC1615, IC1616, IC1617, IC1618, IC1621, IC1622, IC1623, IC1624, IC1625, IC1626, IC1627, IC1628, IC1629, IC1630, IC1631, IC1632, IC1633, IC1634, IC1635, IC1636, IC1637, IC1638, IC1639, IC1640, IC1641, IC1642, IC1643, IC1644, IC1645, IC1646, IC1648, IC1650, IC1651, IC1652, IC1654, IC1655, IC1656, IC1657, IC1658, IC1659, IC1660, IC1661, IC1662, IC1663, IC1666, IC1668, IC1669, IC1670, IC1671, IC1672, IC1673, IC1674, IC1675, IC1679, IC1680, IC1681, IC1682, IC1683, IC1686, IC1687, IC1688, IC1689, IC1690, IC1691, IC1692, IC1693, IC1694, IC1695, IC1696, IC1697, IC1698, IC1701, IC1702, IC1703, IC1704, IC1705, IC1707, IC1708, IC1709, IC1710, IC1711, IC1712, IC1713, IC1714, IC1716, IC1717, IC1718, IC1719, IC1728, IC1729, IC1730, IC1731, IC1732, IC1733, IC1734, IC1735, IC1736, IC1737, IC1738, IC1739, IC1740, IC1741, IC1742, IC1743, IC1744, IC1746, IC1747, IC1748, IC1749, IC1750, IC1751, IC1752, IC1753, IC1754, IC1755, IC1756, IC1757, IC1758, IC1759, IC1760, IC1770, IC1771, IC1772, IC1773, IC1774, IC1776, IC1777, IC1778, IC1779, IC1781, IC1783, IC1784, IC1785, IC1786, IC1787, IC1788, IC1789, IC1793, IC1794, IC1795, IC1797, IC1799, IC1800, IC1801, IC1802, IC1803, IC1804, IC1805, IC1806, IC1807, IC1808, IC1809, IC1810, IC1811, IC1812, IC1813, IC1814, IC1815, IC1816, IC1817, IC1818, IC1819, IC1820, IC1827, IC1828, IC1829, IC1830, IC1831, IC1832, IC1833, IC1834, IC1835, IC1836, IC1837, IC1838, IC1839, IC1840, IC1841, IC1842, IC1843, IC1844, IC1845, IC1846, IC1847, IC1848, IC1849, IC1850, IC1851, IC1852, IC1853, IC1854, IC1855, IC1857, IC1858, IC1859, IC1860, IC1861, IC1862, IC1863, IC1864, IC1865, IC1866, IC1867, IC1875, IC1877, IC1878, IC1879, IC1880, IC1882, IC1883, IC1884, IC1885, IC1887, IC1888, IC1889, IC1890, IC1891, IC1892, IC1893, IC1894, IC1895, IC1896, IC1897, IC1898, IC1899, IC1900, IC1914, IC1915, IC1916, IC1917, IC1918, IC1919, IC1920, IC1921, IC1922, IC1923, IC1924, IC1925, IC1926, IC1928, IC1929, IC1930, IC1931, IC1932, IC1933, IC1934, IC1935, IC1936, IC1937, IC1938, IC1939, IC1940, IC1941, IC1942, IC1943, IC1944, IC1945, IC1946, IC1947, IC1948, IC1949, IC1950, IC1951, IC1952, IC1953, IC1954, IC1955, IC1956, IC1957, IC1958, IC1959, IC1960, IC1961, IC1962, IC1963, IC1964, IC1965, IC1966, IC1967, IC1968, IC1969, IC1970, IC1979, IC1980, IC1981, IC1982, IC1983, IC1984, IC1985, IC1986, IC1987, IC1988, IC1989, IC1990, IC1991, IC1992, IC1993, IC1994, IC1995, IC1996, IC1997, IC1998, IC1999, IC2000, IC2001, IC2002, IC2003, IC2004, IC2007, IC2008, IC2010, IC2011, IC2012, IC2013, IC2014, IC2015, IC2016, IC2017, IC2018, IC2019, IC2020, IC2022, IC2026, IC2027, IC2028, IC2029, IC2030, IC2031, IC2036, IC2037, IC2041, IC2042, IC2043, IC2044, IC2045, IC2046, IC2047, IC2048, IC2049, IC2050, IC2051, IC2052, IC2053, IC2054, IC2055, IC2056, IC2057, IC2058, IC2059, IC2060, IC2061, IC2062, IC2063, IC2064, IC2065, IC2066, IC2067, IC2068, IC2069, IC2070, IC2071, IC2072, IC2073, IC2074, IC2075, IC2076, IC2077, IC2078, IC2079, IC2080, IC2081, IC2082, IC2083, IC2084, IC2085, IC2086, IC2087, IC2088, IC2089, IC2090, IC2091, IC2092, IC2093, IC2094, IC2103, IC2104, IC2105, IC2106, IC2107, IC2108, IC2109, IC2110, IC2111, IC2112, IC2113, IC2114, IC2115, IC2116, IC2117, IC2118, IC2119, IC2120, IC2121, IC2122, IC2124, IC2125, IC2126, IC2127, IC2128, IC2129, IC2130, IC2131, IC2132, IC2133, IC2134, IC2135, IC2136, IC2137, IC2138, IC2139, IC2140, IC2141, IC2142, IC2146, IC2147, IC2148, IC2149, IC2150, IC2152, IC2153, IC2154, IC2155, IC2157, IC2158, IC2159, IC2160, IC2161, IC2162, IC2163, IC2164, IC2165, IC2166, IC2167, IC2168, IC2169, IC2170, IC2177, IC2180, IC2181, IC2182, IC2183, IC2184, IC2185, IC2186, IC2187, IC2188, IC2189, IC2190, IC2191, IC2192, IC2193, IC2194, IC2195, IC2196, IC2197, IC2198, IC2200, IC2201, IC2202, IC2203, IC2208, IC2209, IC2210, IC2211, IC2212, IC2213, IC2214, IC2215, IC2216, IC2217, IC2218, IC2223, IC2224, IC2225, IC2227, IC2228, IC2229, IC2230, IC2237, IC2238, IC2246, IC2247, IC2248, IC2249, IC2250, IC2251, IC2252, IC2253, IC2254, IC2255, IC2256, IC2257, IC2258, IC2259, IC2260, IC2261, IC2262, IC2263, IC2264, IC2265, IC2269, IC2270, IC2271, IC2272, IC2273, IC2274, IC2275, IC2276, IC2279, IC2280, IC2281, IC2282, IC2283, IC2284, IC2285, IC2286, IC2287, IC2288, IC2289, IC2290, IC2291, IC2292, IC2293, IC2294, IC2295, IC2296, IC2297, IC2298, IC2299, IC2300, IC2301, IC2302, IC2303, IC2304, IC2305, IC2306, IC2307, IC2308, IC2309, IC2310, IC2311, IC2312, IC2313, IC2314, IC2315, IC2316, IC2317, IC2318, IC2319, IC2320, IC2321, IC2322, IC2323, IC2324, IC2333, IC2334, IC2335, IC2336, IC2337, IC2338, IC2339, IC2340, IC2341, IC2342, IC2343, IC2344, IC2345, IC2347, IC2348, IC2349, IC2350, IC2351, IC2352, IC2353, IC2354, IC2355, IC2356, IC2357, IC2358, IC2359, IC2360, IC2361, IC2362, IC2363, IC2364, IC2365, IC2366, IC2371, IC2372, IC2373, IC2374, IC2375, IC2376, IC2377, IC2378, IC2379, IC2381, IC2382, IC2383, IC2384, IC2385, IC2386, IC2387, IC2388, IC2389, IC2390, IC2391, IC2392, IC2393, IC2394, IC2395, IC2396, IC2397, IC2398, IC2399, IC2401, IC2402, IC2403, IC2404, IC2405, IC2406, IC2407, IC2408, IC2409, IC2410, IC2415, IC2416, IC2417, IC2418, IC2419, IC2420, IC2421, IC2422, IC2423, IC2424, IC2425, IC2426, IC2427, IC2428, IC2429, IC2430, IC2431, IC2432, IC2433, IC2434, IC2435, IC2436, IC2437, IC2438, IC2439, IC2440, IC2445, IC2446, IC2447, IC2448, IC2450, IC2454, IC2456, IC2457, IC2458, IC2462, IC2463, IC2464, IC2465, IC2466, IC2467, IC2468, IC2480, IC2482, IC2487, IC2488, IC2489, IC2495, IC2498, IC2499, IC2500, IC2501, IC2502, IC2503, IC2504, IC2505, IC2506, IC2507, IC2508, IC2509, IC2510, IC2511, IC2513, IC2514, IC2515, IC2516, IC2517, IC2518, IC2519, IC2520, IC2521, IC2522, IC2523, IC2524, IC2525, IC2526, IC2527, IC2528, IC2529, IC2530, IC2531, IC2532, IC2533, IC2535, IC2536, IC2537, IC2538, IC2539, IC2540, IC2541, IC2542, IC2543, IC2544, IC2545, IC2546, IC2547, IC2548, IC2549, IC2550, IC2551, IC2552, IC2553, IC2554, IC2555, IC2561, IC2562, IC2563, IC2564, IC2565, IC2566, IC2567, IC2568, IC2569, IC2570, IC2571, IC2572, IC2573, IC2574, IC2575, IC2576, IC2577, IC2578, IC2579, IC2580, IC2581, IC2582, IC2583, IC2584, IC2585, IC2586, IC2587, IC2588, IC2589, IC2590, IC2591, IC2592, IC2593, IC2594, IC2595, IC2596, IC2597, IC2598, IC2599, IC2600, IC2601, IC2602, IC2603, IC2604, IC2605, IC2608, IC2611, IC2612, IC2613, IC2614, IC2615, IC2616, IC2617, IC2618, IC2619, IC2620, IC2621, IC2622, IC2623, IC2624, IC2625, IC2626, IC2627, IC2628, IC2629, IC2630, IC2631, IC2632, IC2633, IC2634, IC2635, IC2636, IC2637, IC2638, IC2639, IC2640, IC2641, IC2643, IC2644, IC2645, IC2646, IC2647, IC2648, IC2649, IC2650, IC2651, IC2660, IC2661, IC2662, IC2663, IC2664, IC2665, IC2666, IC2667, IC2671, IC2672, IC2674, IC2675, IC2680, IC2681, IC2682, IC2684, IC2689, IC2690, IC2691, IC2692, IC2693, IC2694, IC2695, IC2696, IC2697, IC2698, IC2699, IC2700, IC2701, IC2702, IC2703, IC2711, IC2713, IC2714, IC2715, IC2716, IC2717, IC2718, IC2719, IC2721, IC2722, IC2723, IC2724, IC2725, IC2726, IC2727, IC2728, IC2729, IC2730, IC2731, IC2732, IC2733, IC2734, IC2735, IC2736, IC2737, IC2738, IC2739, IC2740, IC2741, IC2742, IC2743, IC2744, IC2745, IC2746, IC2747, IC2748, IC2749, IC2759, IC2760, IC2761, IC2762, IC2764, IC2768, IC2769, IC2770, IC2771, IC2772, IC2773, IC2774, IC2775, IC2776, IC2777, IC2778, IC2779, IC2780, IC2781, IC2782, IC2783, IC2784, IC2785, IC2786, IC2787, IC2788, IC2789, IC2790, IC2791, IC2792, IC2793, IC2794, IC2795, IC2796, IC2797, IC2798, IC2799, IC2800, IC2801, IC2802, IC2803, IC2804, IC2805, IC2806, IC2807, IC2808, IC2809, IC2810, IC2811, IC2812, IC2813, IC2814, IC2815, IC2816, IC2817, IC2818, IC2819, IC2820, IC2821, IC2822, IC2831, IC2832, IC2833, IC2834, IC2840, IC2841, IC2842, IC2843, IC2844, IC2845, IC2846, IC2847, IC2848, IC2849, IC2850, IC2851, IC2852, IC2853, IC2854, IC2863, IC2865, IC2866, IC2867, IC2868, IC2869, IC2870, IC2879, IC2880, IC2881, IC2882, IC2883, IC2884, IC2885, IC2886, IC2887, IC2888, IC2889, IC2890, IC2891, IC2892, IC2893, IC2895, IC2896, IC2897, IC2898, IC2899, IC2901, IC2907, IC2908, IC2909, IC2910, IC2913, IC2914, IC2915, IC2916, IC2917, IC2918, IC2919, IC2920, IC2921, IC2922, IC2923, IC2924, IC2925, IC2926, IC2927, IC2928, IC2929, IC2930, IC2931, IC2932, IC2933, IC2934, IC2935, IC2936, IC2937, IC2938, IC2939, IC2940, IC2941, IC2942, IC2943, IC2944, IC2945, IC2946, IC2947, IC2948, IC2949, IC2950, IC2951, IC2952, IC2953, IC2954, IC2955, IC2956, IC2965, IC2966, IC2969, IC2970, IC2971, IC2972, IC2973, IC2974, IC2975, IC2976, IC2977, IC2978, IC2979, IC2980, IC2981, IC2982, IC2983, IC2990, IC2991, IC2992, IC2993, IC2994, IC2995, IC2998, IC2999, IC3000, IC3001, IC3002, IC3003, IC3004, IC3005, IC3006, IC3007, IC3008, IC3009, IC3010, IC3011, IC3012, IC3013, IC3023, IC3024, IC3025, IC3026, IC3027, IC3028, IC3029, IC3030, IC3031, IC3032, IC3033, IC3034, IC3035, IC3036, IC3037, IC3038, IC3039, IC3040, IC3041, IC3042, IC3043, IC3044, IC3045, IC3046, IC3055, IC3056, IC3057, IC3058, IC3059, IC3060, IC3061, IC3062, IC3063, IC3064, IC3065, IC3066, IC3071, IC3072, IC3073, IC3074, IC3075, IC3076, IC3077, IC3078, IC3079, IC3080, IC3081, IC3082, IC3083, IC3084, IC3085, IC3086, IC3087, IC3088, IC3089, IC3090, IC3091, IC3092, IC3093, IC3094, IC3103, IC3104, IC3105, IC3106, IC3107, IC3108, IC3109, IC3110, IC3111, IC3113, IC3114, IC3115, IC3116, IC3117, IC3118, IC3119, IC3120, IC3121, IC3122, IC3123, IC3124, IC3125, IC3126, IC3135, IC3136, IC3137, IC3138, IC3139, IC3140, IC3141, IC3150, IC3151, IC3152, IC3153, IC3154, IC3155, IC3156, IC3157, IC3158, IC3159, IC3160, IC3161, IC3162, IC3163, IC3164, IC3165, IC3168, IC3169, IC3170, IC3171, IC3172, IC3173, IC3176, IC3177, IC3185, IC3186, IC3187, IC3188, IC3189, IC3191, IC3192, IC3193, IC3194, IC3196, IC3197, IC3198, IC3199, IC3200, IC3201, IC3202, IC3203, IC3204, IC3205, IC3206, IC3207, IC3208, IC3209, IC3210, IC3211, IC3212, IC3214, IC3215, IC3216, IC3217, IC3218, IC3219, IC3220, IC3221, IC3222, IC3224, IC3225, IC3226, IC3227, IC3228, IC3229, IC3230, IC3231, IC3232, IC3233, IC3234, IC3235, IC3236, IC3237, IC3238, IC3239, IC3242, IC3243, IC3244, IC3245, IC3246, IC3247, IC3248, IC3249, IC3250, IC3251, IC3252, IC3253, IC3254, IC3255, IC3257, IC3258, IC3259, IC3260, IC3261, IC3262, IC3263, IC3266, IC3267, IC3268, IC3269, IC3270, IC3271, IC3272, IC3273, IC3274, IC3275, IC3276, IC3277, IC3278, IC3279, IC3281, IC3282, IC3283, IC3284, IC3285, IC3336, IC3337, IC3338, IC3339, IC3340, IC3341, IC3342, IC3343, IC3345, IC3346, IC3347, IC3348, IC3349, IC3350, IC3351, IC3352, IC3353, IC3354, IC3355, IC3356, IC3357, IC3358, IC3359, IC3360, IC3361, IC3362, IC3363, IC3364, IC3365, IC3366, IC3367, IC3368, IC3369, IC3370, IC3371, IC3372, IC3373, IC3374, IC3375, IC3376, IC3377, IC3378, IC3379, IC3380, IC3381, IC3382, IC3383, IC3384, IC3385, IC3386, IC3388, IC3390, IC3394, IC3396, IC3397, IC3398, IC3399, IC3400, IC3401, IC3404, IC3405, IC3406, IC3407, IC3408, IC3409, IC3410, IC3411, IC3412, IC3413, IC3414, IC3415, IC3416, IC3417, IC3418, IC3419, IC3420, IC3421, IC3422, IC3423, IC3424, IC3425, IC3426, IC3427, IC3428, IC3429, IC3432, IC3433, IC3434, IC3436, IC3437, IC3438, IC3439, IC3440, IC3441, IC3443, IC3444, IC3445, IC3446, IC3447, IC3448, IC3449, IC3450, IC3451, IC3452, IC3453, IC3454, IC3455, IC3496, IC3497, IC3498, IC3499, IC3500, IC3501, IC3502, IC3503, IC3504, IC3505, IC3506, IC3507, IC3508, IC3509, IC3510, IC3511, IC3512, IC3513, IC3514, IC3515, IC3516, IC3517, IC3518, IC3519, IC3520, IC3521, IC3522, IC3523, IC3524, IC3525, IC3526, IC3527, IC3528, IC3529, IC3530, IC3542, IC3543, IC3544, IC3545, IC3546, IC3547, IC3548, IC3549, IC3550, IC3551, IC3552, IC3553, IC3554, IC3555, IC3556, IC3557, IC3561, IC3562, IC3563, IC3564, IC3565, IC3566, IC3567, IC3568, IC3569, IC3570, IC3571, IC3572, IC3573, IC3574, IC3577, IC3578, IC3579, IC3580, IC3581, IC3582, IC3589, IC3590, IC3591, IC3592, IC3594, IC3595, IC3596, IC3599, IC3600, IC3601, IC3602, IC3603, IC3604, IC3609, IC3610, IC3622, IC3623, IC3624, IC3625, IC3626, IC3627, IC3628, IC3629, IC3630, IC3631, IC3632, IC3633, IC3634, IC3635, IC3636, IC3637, IC3638, IC3640, IC3641, IC3642, IC3643, IC3644, IC3645, IC3646, IC3647, IC3648, IC3649, IC3650, IC3679, IC3680, IC3681, IC3684, IC3685, IC3688, IC3689, IC3690, IC3691, IC3693, IC3694, IC3695, IC3710, IC3711, IC3712, IC3713, IC3714, IC3715, IC3725, IC3726, IC3727, IC3728, IC3729, IC3730, IC3731, IC3732, IC3733, IC3734, IC3735, IC3736, IC3737, IC3738, IC3739, IC3740, IC3741, IC3742, IC3743, IC3744, IC3745, IC3746, IC3747, IC3748, IC3749, IC3750, IC3751, IC3752, IC3753, IC3754, IC3766, IC3768, IC3769, IC3770, IC3771, IC3772, IC3773, IC3774, IC3775, IC3786, IC3787, IC3788, IC3789, IC3790, IC3791, IC3792, IC3793, IC3794, IC3795, IC3796, IC3797, IC3798, IC3799, IC3800, IC3801, IC3804, IC3805, IC3806, IC3807, IC3808, IC3809, IC3810, IC3811, IC3819, IC3820, IC3821, IC3822, IC3823, IC3825, IC3826, IC3835, IC3838, IC3839, IC3840, IC3841, IC3842, IC3843, IC3844, IC3845, IC3846, IC3847, IC3848, IC3849, IC3850, IC3851, IC3852, IC3853, IC3854, IC3855, IC3856, IC3857, IC3858, IC3865, IC3876, IC3877, IC3878, IC3879, IC3880, IC3881, IC3882, IC3883, IC3892, IC3893, IC3894, IC3895, IC3896, IC3897, IC3898, IC3899, IC3900, IC3901, IC3902, IC3903, IC3904, IC3906, IC3907, IC3908, IC3909, IC3910, IC3911, IC3912, IC3913, IC3914, IC3915, IC3916, IC3917, IC3918, IC3919, IC3920, IC3921, IC3922, IC3923, IC3924, IC3925, IC3926, IC3927, IC3928, IC3929, IC3930, IC3931, IC3932, IC3933, IC3934, IC3935, IC3937, IC3938, IC3939, IC3940, IC3941, IC3942, IC3943, IC3944, IC3945, IC3946, IC3947, IC3948, IC3949, IC3950, IC3951, IC3952, IC3953, IC3954, IC3955, IC3956, IC3957, IC3958, IC3959, IC3960, IC3961, IC3962, IC3963, IC3964, IC3965, IC3966, IC3967, IC3968, IC3969, IC3970, IC3971, IC3972, IC3973, IC3974, IC3975, IC3976, IC3979, IC3980, IC3981, IC3982, IC3983, IC3984, IC3985, IC3986, IC3987, IC3988, IC3989, IC3990, IC3991, IC3992, IC3993, IC3994, IC3995, IC3996, IC3997, IC3998, IC3999, IC4000, IC4001, IC4003, IC4004, IC4005, IC4007, IC4008, IC4009, IC4010, IC4011, IC4016, IC4018, IC4019, IC4020, IC4021, IC4022, IC4023, IC4024, IC4025, IC4026, IC4027, IC4028, IC4029, IC4030, IC4031, IC4038, IC4039, IC4040, IC4041, IC4042, IC4043, IC4044, IC4045, IC4060, IC4061, IC4062, IC4063, IC4064, IC4067, IC4070, IC4071, IC4072, IC4073, IC4074, IC4075, IC4076, IC4077, IC4084, IC4085, IC4087, IC4088, IC4089, IC4090, IC4091, IC4101, IC4102, IC4103, IC4104, IC4105, IC4106, IC4107, IC4108, IC4109, IC4110, IC4111, IC4112, IC4113, IC4114, IC4115, IC4116, IC4130, IC4131, IC4132, IC4133, IC4134, IC4135, IC4136, IC4137, IC4158, IC4159, IC4160, IC4161, IC4162, IC4163, IC4164, IC4165, IC4167, IC4168, IC4169, IC4170, IC4171, IC4172, IC4173, IC4174, IC4191, IC4192, IC4194, IC4195, IC4196, IC4197, IC4198, IC4199, IC4200, IC4201, IC4202, IC4203, IC4204, IC4205, IC4206, IC4219, IC4220, IC4221, IC4222, IC4223, IC4224, IC4225, IC4226, IC4243, IC4244, IC4245, IC4246, IC4247, IC4248, IC4249, IC4250, IC4259, IC4260, IC4261, IC4262, IC4263, IC4264, IC4265, IC4266, IC4267, IC4268, IC4269, IC4270, IC4271, IC4272, IC4273, IC4274, IC4275, IC4276, IC4277, IC4278, IC4279, IC4280, IC4281, IC4282, IC4283, IC4284, IC4285, IC4290, IC4291, IC4292, IC4293, IC4294, IC4295, IC4297, IC4298, IC4299, IC4300, IC4301, IC4302, IC4303, IC4304, IC4305, IC4306, IC4307, IC4308, IC4309, IC4310, IC4311, IC4312, IC4313, IC4314, IC4315, IC4316, IC4317, IC4318, IC4320, IC4321, IC4333, IC4336, IC4337, IC4339, IC4340, IC4341, IC4342, IC4343, IC4344, IC4345, IC4346, IC4347, IC4348, IC4349, IC4350, IC4351, IC4352, IC4353, IC4354, IC4372, IC4373, IC4374, IC4375, IC4376, IC4377, IC4378, IC4379, IC4380, IC4381, IC4382, IC4383, IC4386, IC4387, IC4389, IC4390, IC4391, IC4392, IC4393, IC4394, IC4395, IC4396, IC4397, IC4398, IC4399, IC4400, IC4401, IC4402, IC4403, IC4404, IC4405, IC4406, IC4407, IC4408, IC4409, IC4410, IC4411, IC4412, IC4413, IC4414, IC4415, IC4416, IC4417, IC4418, IC4419, IC4420, IC4422, IC4423, IC4424, IC4425, IC4426, IC4427, IC4428, IC4429, IC4430, IC4431, IC4432, IC4433, IC4434, IC4435, IC4436, IC4437, IC4453, IC4454, IC4455, IC4456, IC4457, IC4458, IC4459, IC4460, IC4461, IC4462, IC4463, IC4472, IC4473, IC4474, IC4475, IC4476, IC4477, IC4478, IC4479, IC4480, IC4481, IC4482, IC4483, IC4484, IC4485, IC4486, IC4487, IC4488, IC4489, IC4490, IC4491, IC4492, IC4493, IC4494, IC4495, IC4496, IC4497, IC4498, IC4499, IC4504, IC4509, IC4510, IC4511, IC4512, IC4513, IC4514, IC4515, IC 4516, IC4517, IC4518, IC4519, IC4520, IC4521, IC4522, IC4523, IC4524, IC4526, IC4527, IC4528, IC4529, IC4530, IC4531, IC4532, IC4533, IC4534, IC4535, IC4536, IC4537, IC4538, IC4539, IC4540, IC4541, IC4542, IC4543, IC4544, IC4545, IC4546, IC4547, IC4548, IC4549, IC4550, IC4551, IC4552, IC4554, IC4555, IC4556, IC4558, IC4570, IC4571, IC4572, IC4573, IC4574, IC4575, IC4576, IC4577, IC4578, IC4579, IC4580, IC4581, IC4582, IC4583, IC4584, IC4588, IC4591, IC4593, IC4596, IC4601, IC4602, IC4603, IC4604, IC4605, IC4606, IC4607, IC4608, IC4615, IC4616, IC4617, IC4618, IC4619, IC4620, IC4621, IC4637, IC4638, IC4639, IC4640, IC4641, IC4642, IC4643, IC4644, IC4659, IC4660, IC4661, IC4662, IC4663, IC4664, IC4665, IC4666, IC4667, IC4668, IC4669, IC4670, IC4671, IC4672, IC4673, IC4674, IC4683, IC4684, IC4685, IC4686, IC4687, IC4688, IC4689, IC4690, IC4691, IC4692, IC4693, IC4694, IC4695, IC4696, IC4697, IC4698, IC4699, IC4700, IC4701, IC4702, IC4703, IC4704, IC4705, IC4706, IC4707, IC4708, IC4709, IC4710, IC4711, IC4712, IC4713, IC4714, IC4715, IC4716, IC4717, IC4718, IC4719, IC4720, IC4744, IC4749, IC4750, IC4751, IC4752, IC4753, IC4754, IC4755, IC4756, IC4764, IC4765, IC4766, IC4767, IC4768, IC4769, IC4770, IC4771, IC4772, IC4773, IC4774, IC4775, IC4776, IC4777, IC4778, IC4779, IC4782, IC4783, IC4784, IC4785, IC4786, IC4787, IC4788, IC4789, IC4798, IC4799, IC4800, IC4801, IC4802, IC4803, IC4804, IC4805, IC4806, IC4807, IC4808, IC4809, IC4810, IC4811, IC4812, IC4813, IC4814, IC4825, IC4826, IC4827, IC4828, IC4829, IC4830, IC4831, IC4832, IC4854, IC4858, IC4859, IC4860, IC4861, IC4862, IC4863, IC4864, IC4865, IC4884, IC4885, IC4886, IC4887, IC4888, IC4889, IC4890, IC4893, IC4894, IC4895, IC4896, IC4897, IC4898, IC4899, IC4900, IC4902, IC4903, IC4904, IC4905, IC4906, IC4907, IC4908, IC4909, IC4918, IC4919, IC4920, IC4921, IC4922, IC4923, IC4924, IC4925, IC4935, IC4936, IC4937, IC4938, IC4939, IC4940, IC4941, IC4942, IC4943, IC4956, IC4962, IC4963, IC4964, IC4965, IC4966, IC4967, IC4968, IC4969, IC4970, IC4971, IC4972, IC4974, IC4975, IC4976, IC4977, IC4978, IC4979, IC4980, IC4981, IC4982, IC4983, IC4989, IC4990, IC4991, IC4992, IC4993, IC4994, IC4995, IC4996, IC4997, IC4998, IC4999, IC5001, IC5002, IC5003, IC5004, IC5005, IC5006, IC5017, IC5018, IC5019, IC5024, IC5052, IC5054, IC5056, IC5058, IC5059, IC5060, IC5061, IC5062, IC5063, IC5064, IC5066, IC5067, IC5068, IC5069, IC5070, IC5071, IC5072, IC5073, IC5074, IC5089, IC5090, IC5091, IC5092, IC5093, IC5094, IC5095, IC5116, IC5117, IC5118, IC5119, IC5120, IC5122, IC5123, IC5124, IC5125, IC5146, IC5147, IC5148, IC5149, IC5150, IC5151, IC5152, IC5153, IC5154, IC5155, IC5166, IC5167, IC5168, IC5170, IC5172, IC5183, IC5185, IC5188, IC5189, IC5190, IC5191, IC5192, IC5196, IC5197, IC5198, IC5199, IC5200, IC5201, IC5202, IC5203, IC5204, IC5205, IC5206, IC5207, IC5208, IC5209, IC5221, IC5222, IC5223, IC5224, IC5225, IC5242, IC5244, IC5262, IC5263, IC5264, IC5265, IC5266, IC5267, IC5268, IC5269, IC5270, IC5271, IC5272, IC5273, IC5274, IC5275, IC5286, IC5287, IC5288, IC5289, IC5290, IC5291, IC5292, IC5293, IC5294, IC5295, IC5296, IC5297, IC5298, IC5299, IC5300, IC5301, IC5302, IC5303, IC5304, IC5305, IC5306, IC5307, IC5308, IC5309, IC5310, IC5311, IC5312, IC5313, IC5314, IC5315, IC5316, IC5317, IC5318, IC5319, IC5320, IC5321, IC5322, IC5323, IC5324, IC5325, IC5326, IC5327, IC5328, IC5329, IC5330, IC5332, IC5333, IC5334, IC5335, IC5336, IC5337, IC5338, IC5339, IC5340, IC5342, IC5343, IC5344, IC5345, IC5358, IC5359, IC5360, IC5361, IC5362, IC5363, IC5364, IC5365, IC5366, IC5367, IC5368, IC5369, IC5370, IC5371, IC5372, IC5373, IC5374, IC5375, IC5386, IC5387, IC5388, IC5389, IC5390, IC5393, IC5394, IC5395, IC5416, IC5417, IC5418, IC5419, IC5420, IC5425, IC5453, IC5454, IC5455, IC5456, IC5457, IC5458, IC5459, IC5468, IC5469, IC5470, IC5471, IC5472, IC5473, IC5474, IC5475, IC5479, IC5480, IC5481, IC5482, IC5483, IC5484, IC5485, IC5486, IC5498, IC5499, IC5500, IC5501, IC5502, IC5503, IC5504, IC5536, IC5537, IC5538, IC5539, IC5540, IC5541, IC5542, IC5543, IC5544, IC5545, IC5546, IC5547, IC5548, IC5549, IC5550, IC5551, IC5552, IC5561, IC5562, IC5564, IC5565, IC5596, IC5597, IC5598, IC5599, IC5600, IC5601, IC5602, IC5603, IC5604, IC5605, IC5606, IC5607, IC5608, IC5609, IC5610, IC5612, IC5613, IC5614, IC5615, IC5616, IC5617, IC5619, IC5620, IC5621, IC5623, IC5624, IC5625, IC5647, IC5648, IC5649, IC5650, IC5655, IC5661, IC5662, IC5663, IC5664, IC5676, IC5678, IC5690, IC5691, IC5692, IC5693, IC5694, IC5695, IC5696, IC5697, IC5698, IC5699, IC5701, IC5702, IC5703, IC5704, IC5705, IC5706, IC5707, IC5708, IC5709, IC5710, IC5711, IC5712, IC5713, IC5718, IC5719, IC5720, IC5721, IC5723, IC5724, IC5725, IC5726, IC5736, IC5737, IC5738, IC5739, IC5740, IC5741, IC5742, IC5743, IC5745, IC5746, IC5747, IC5748, IC5749, IC5750, IC5758, IC5759, IC5760, IC5761, IC5762, IC5763, IC5764, IC5765, IC5766, IC5767, IC5768, IC5769, IC5770, IC5772, IC5773, IC5776, IC5778, IC5787, IC5788, IC5789, IC5790, IC5791, IC5792, IC5793, IC5794, IC5795, IC5816, IC5822, IC5823, IC5825, IC5826, IC5827, IC5828, IC5829, IC5838, IC5839, IC5840, IC5841, IC5842, IC5843, IC5844, IC5845, IC5846, IC5847, IC5848, IC5849, IC5850, IC5851, IC5852, IC5853, IC5854, IC5855, IC5856, IC5857, IC5858, IC5859, IC5870, IC5871, IC5872, IC5873, IC5874, IC5875, IC5876, IC5877, IC5878, IC5879, IC5880, IC5881, IC5882, IC5883, IC5884, IC5885, IC5886, IC5887, IC5888, IC5889, IC5890, IC5891, IC5892, IC5893, IC5894, IC5895, IC5906, IC5907, IC5908, IC5909, IC5933, IC5939, IC5940, IC5941, IC5942, IC5943, IC5944, IC5945, IC5946, IC5947, IC5948, IC5949, IC5950, IC5951, IC5952, IC5953, IC5954, IC5955, IC5976, IC5977, IC5978, IC5979, IC5980, IC5981, IC5982, IC5983, IC5984, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5991, IC5992, IC5993, IC5994, IC6000, IC6002, IC6003, IC6004, IC6005, IC6026, IC6027, IC6028, IC6029, IC6030, IC6031, IC6032, IC6033, IC6034, IC6035, IC6036, IC6037, IC6038, IC6039, IC6040, IC6041, IC6042, IC6043, IC6044, IC6045, IC6050, IC6051, IC6052, IC6053, IC6054, IC6055, IC6056, IC6057, IC6058, IC6059, IC6060, IC6061, IC6062, IC6063, IC6077, IC6092, IC6093, IC6094, IC6095, IC6096, IC6097, IC6098, IC6099, IC6100, IC6101, IC6102, IC6103, IC6104, IC6105, IC6106, IC6107, IC6115, IC6128, IC6129, IC6130, IC6131, IC6132, IC6133, IC6134, IC6135, IC6136, IC6137, IC6138, IC6140, IC6141, IC6142, IC6143, IC6144, IC6145, IC6146, IC6152, IC6153, IC6154, IC6155, IC6156, IC6157, IC6158, IC6159, IC6160, IC6161, IC6176, IC6177, IC6178, IC6179, IC6180, IC6181, IC6182, IC6183, IC6184, IC6185, IC6186, IC6187, IC6188, IC6189, IC6190, IC6191, IC6192, IC6193, IC6194, IC6195, IC6196, IC6197, IC6198, IC6199, IC6200, IC6201, IC6206, IC6208, IC6213, IC6215, IC6217, IC6218, IC6219, IC6220, IC6221, IC6222, IC6237, IC6238, IC6239, IC6240, IC6241, IC6242, IC6243, IC6244, IC6245, IC6246, IC6247, IC6248, IC6249, IC6250, IC6251, IC6255, IC6266, IC6267, IC6268, IC6269, IC6271, IC6288, IC6295, IC6317, IC6318, IC6319, IC6320, IC6321, IC6322, IC6323, IC6324, IC6325, IC6326, IC6327, IC6328, IC6329, IC6333, IC6334, IC6335, IC6346, IC6347, IC6348, IC6349, IC6350, IC6351, IC6352, IC6353, IC6354, IC6355, IC6356, IC6357, IC6358, IC6359, IC6360, IC6361, IC6362, IC6363, IC6364, IC6365, IC6366, IC6367, IC6368, IC6369, IC6390, IC6391, IC6392, IC6393, IC6394, IC6395, IC6396, IC6397, IC6398, IC6399, IC6400, IC6401, IC6402, IC6403, IC6404, IC6408, IC6409, IC6410, IC6411, IC6412, IC6413, IC6414, IC6415, IC6426, IC6427, IC6428, IC6433, IC6438, IC6444, IC6445, IC6446, IC6447, IC6448, IC6450, IC6453, IC6454, IC6455, IC6470, IC6471, IC6472, IC6473, IC6479, IC6480, IC6481, IC6482, IC6483, IC6484, IC6485, IC6486, IC6495, IC6496, IC6497, IC6498, IC6499, IC6500, IC6501, IC6502, IC6503, IC6504, IC6505, IC6506, IC6507, IC6508, IC6509, IC6511, IC6512, IC6513, IC6514, IC6515, IC6516, IC6517, IC6518, IC6520, IC6521, IC6522, IC6523, IC6524, IC6525, IC6544, IC6545, IC6546, IC6547, IC6557, IC6558, IC6559, IC6560, IC6561, IC6562, IC6563, IC6564, IC6565, IC6566, IC6567, IC6568, IC6569, IC6570, IC6571, IC6572, IC6573, IC6574, IC6575, IC6576, IC6596, IC6597, IC6598, IC6599, IC6600, IC6601, IC6602, IC6603, IC6604, IC6611, IC6612, IC6613, IC6614, IC6615, IC6616, IC6617, IC6618, IC6619, IC6620, IC6621, IC6622, IC6623, IC6624, IC6625, IC6626, IC6627, IC6628, IC6629, IC6630, IC6631, IC6632, IC6637, IC6639, IC6640, IC6641, IC6643, IC6644, IC6645, IC6646, IC6647, IC6648, IC6649, IC6663, IC6664, IC6665, IC6666, IC6667, IC6668, IC6672, IC6673, IC6674, IC6675, IC6676, IC6677, IC6678, IC6679, IC6680, IC6681, IC6682, IC6683, IC6684, IC6685, IC6686, IC6687, IC6718, IC6719, IC6720, IC6721, IC6722, IC6723, IC6724, IC6725, IC6726, IC6727, IC6729, IC6730, IC6731, IC6732, IC6733, IC6734, IC6735, IC6736, IC6737, IC6743, IC6744, IC6753, IC6754, IC6755, IC6766, IC6767, IC6768, IC6769, IC6770, IC6771, IC6772, IC6773, IC6774, IC6775, IC6796, IC6797, IC6798, IC6799, IC6800, IC6801, IC6802, IC6803, IC6811, IC6815, IC6816, IC6817, IC6818, IC6819, IC6820, IC6822, IC6823, IC6824, IC6825, IC6826, IC6827, IC6828, IC6829, IC6830, IC6831, IC6832, IC6833, IC6834, IC6835, IC6836, IC6837, IC6838, IC6839, IC6840, IC6841, IC6842, IC6846, IC6847, IC6848, IC6849, IC6850, IC6851, IC6852, IC6853, IC6854, IC6864, IC6865, IC6889, IC6893, IC6894, IC6895, IC6896, IC6897, IC6898, IC6899, IC6900, IC6901, IC6904, IC6905, IC6906, IC6907, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6914, IC6915, IC6916, IC6917, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6926, IC6927, IC6928, IC6929, IC6930, IC6931, IC6932, IC6933, IC6935, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6982, IC6983, IC6984, IC7026, IC7027, IC7028, IC7030, IC7032, IC7919, IC7922, IC3575, IC3576, IC3836, IC3837, IC4065, IC4066, IC4451, IC4452, IC6330, IC6332, IC3166, IC3167, IC3213, IC3223, IC2449, IC2451, IC2452, IC2453, IC2459, IC2460, IC2461, IC1001, IC1002, IC1098, IC1099, IC1140, IC1179;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3148-2026%22", "url": "https://recallledger.net/recalls/device-z-3148-2026-automated-impella-controller-aic-with-the-below-product-descriptions/"}, {"id": "fda-device-z-3127-2026", "source": "FDA", "category": "device", "recall_number": "Z-3127-2026", "title": "Medline Convenience Kits: 1) DYNDB3086D recall (Medline Industries, LP)", "product": "Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D;  2) DYNDB3100, Catalog Number: DYNDB3100;  3) DYNDH1619A, Catalog Number: DYNDH1619A;  4) DYNDH1620A, Catalog Number: DYNDH1620A;  5) DYNDH1694A, Catalog Number: DYNDH1694A;  6) DYNDH1695, Catalog Number: DYNDH1695;  7) DYNDH1708A, Catalog Number: DYNDH1708A;  8) DYNDH1714A, Catalog Number: DYNDH1714A;  9) DYNDH1723, Catalog Number: DYNDH1723;  10) DYNDH1740B, Catalog Number: DYNDH1740B;  11) DYNDH1741B, Catalog Number: DYNDH1741B;  12) DYNDH1771A, Catalog Number: DYNDH1771A;  13) DYNDH1908, Catalog Number: DYNDH1908;  14) DYNDH1940, Catalog Number: DYNDH1940;  15) DYNDH1988, Catalog Number: DYNDH1988;  16) DYNDH2002, Catalog Number: DYNDH2002;  17) DYNDH2017, Catalog Number: DYNDH2017.  Blood and urine collection kits", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "47848 kits", "codes": "1) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24IBA685; 2) DYNDB3100, UDI-DI: 10198459028915(each), 40198459028916(case), Lot Number: 24IBF913; 3) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24FBH708; 4) DYNDH1619A, UDI-DI: 10195327215835(each), 40195327215836(case), Lot Number: 24HBG622; 5) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24GBY827; 6) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBQ593; 7) DYNDH1620A, UDI-DI: 10195327216047(each), 40195327216048(case), Lot Number: 24HBU881; 8) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24EBI901; 9) DYNDH1694A, UDI-DI: 10195327139957(each), 40195327139958(case), Lot Number: 24HBG834; 10) DYNDH1695, UDI-DI: 10195327113155(each), 40195327113156(case), Lot Number: 24FBQ907; 11) DYNDH1708A, UDI-DI: 10195327498368(each), 40195327498369(case), Lot Number: 24IBQ580; 12) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24EBI892; 13) DYNDH1714A, UDI-DI: 10195327347550(each), 40195327347551(case), Lot Number: 24IBE380; 14) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24EBI893; 15) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24GBH135; 16) DYNDH1723, UDI-DI: 10195327134204(each), 40195327134205(case), Lot Number: 24HBG826; 17) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24EBV834; 18) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBH710; 19) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24FBK197; 20) DYNDH1740B, UDI-DI: 10198459006302(each), 40198459006303(case), Lot Number: 24GBW340; 21) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24FBJ622; 22) DYNDH1741B, UDI-DI: 10198459006319(each), 40198459006310(case), Lot Number: 24GBW330; 23) DYNDH1771A, UDI-DI: 10198459088971(each), 40198459088972(case), Lot Number: 24IBJ998; 24) DYNDH1908, UDI-DI: 10195327472467(each), 40195327472468(case), Lot Number: 24EBC055; 25) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24FMH509; 26) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24HBF080; 27) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24GBO301; 28) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24HBQ827; 29) DYNDH2017, UDI-DI: 10198459022159(each), 40198459022150(case), Lot Number: 24HBO219", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3127-2026%22", "url": "https://recallledger.net/recalls/device-z-3127-2026-medline-convenience-kits-1-dyndb3086d-catalog-number-dyndb3086d/"}, {"id": "fda-device-z-3126-2026", "source": "FDA", "category": "device", "recall_number": "Z-3126-2026", "title": "Medline Convenience Kits:  1) DYNDH1193 recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) DYNDH1193, Catalog Number: DYNDH1193;   2) DYNDH1487A, Catalog Number: DYNDH1487A", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1100 kits", "codes": "1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3126-2026%22", "url": "https://recallledger.net/recalls/device-z-3126-2026-medline-convenience-kits-1-dyndh1193-catalog-number-dyndh1193/"}, {"id": "fda-device-z-3125-2026", "source": "FDA", "category": "device", "recall_number": "Z-3125-2026", "title": "Medline Convenience Kits:  1) DYKM1000B recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) DYKM1000B, Catalog Number: DYKM1000B;   2) DYKM2187A, Catalog Number: DYKM2187A", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "2718 kits", "codes": "1) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24GMD979; 2) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24FBM840; 3) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24HBK903", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3125-2026%22", "url": "https://recallledger.net/recalls/device-z-3125-2026-medline-convenience-kits-1-dykm1000b-catalog-number-dykm1000b/"}, {"id": "fda-device-z-3124-2026", "source": "FDA", "category": "device", "recall_number": "Z-3124-2026", "title": "Medline Convenience Kits:  1) ACC010308A recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) ACC010308A, Catalog Number: ACC010308A;   2) ACC010374A, Catalog Number: ACC010374A;   3) ACC010679, Catalog Number: ACC010679;   4) ACC010726A, Catalog Number: ACC010726A;   5) DYNDB3061, Catalog Number: DYNDB3061;   6) DYNDH1245, Catalog Number: DYNDH1245;   7) DYNDH1362, Catalog Number: DYNDH1362", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "10407 kits", "codes": "1) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24HDA993; 2) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24IDB285; 3) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24JDA212; 4) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24IDB849; 5) ACC010679, UDI-DI: 10195327396268(each), 40195327396269(case), Lot Number: 24HDA071; 6) ACC010726A, UDI-DI: 10198459043666(each), 40198459043667(case), Lot Number: 24GDB143; 7) DYNDB3061, UDI-DI: 10889942143733(each), 40889942143734(case), Lot Number: 24HBS752; 8) DYNDH1245, UDI-DI: 10889942604722(each), 40889942604723(case), Lot Number: 24FMH385; 9) DYNDH1362, UDI-DI: 10888277797086(each), 40888277797087(case), Lot Number: 24HBQ828", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3124-2026%22", "url": "https://recallledger.net/recalls/device-z-3124-2026-medline-convenience-kits-1-acc010308a-catalog-number-acc010308a/"}, {"id": "fda-device-z-3123-2026", "source": "FDA", "category": "device", "recall_number": "Z-3123-2026", "title": "Medline Convenience Kits:  1) PORT ACCESS KIT UNIV OF ALA recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414;   2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "447 kits", "codes": "1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24HBS933; 2) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24HBT600", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3123-2026%22", "url": "https://recallledger.net/recalls/device-z-3123-2026-medline-convenience-kits-1-port-access-kit-univ-of-ala-catalog-num/"}, {"id": "fda-device-z-3122-2026", "source": "FDA", "category": "device", "recall_number": "Z-3122-2026", "title": "Medline Convenience Kits:  1) OPEN HEART ADULT recall (Medline Industries, LP)", "product": "Medline Convenience Kits:  1) OPEN HEART ADULT, Catalog Number: CDS840396Y;   2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O;   3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080", "reason": "The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. 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22600-0007T 10885403239595 50885403239593 BD Alaris Pump Infusion Set, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 2408-0500 10885403235030 50885403235038 GEM 10DP CKV 4WAY-STPCK 4SS 2420-0500 7613203012430 37613203012448 BD Alaris Pump Infusion Set, Back Check Valve, 2 SmartSite Y-sites 2428-0007 10885403220883 50885403220881 BD Alaris Pump Infusion Set, 2 Back Check Valves, 4 SmartSite Y-sites 2455-0500 7613203021296 37613203021303 BD Alaris Pump Infusion Set, SmartSite Y-site 2466-0007 10885403221958 50885403221956 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 2206-0007 7613203019224 37613203019232 BD Alaris Pump Infusion Set, Yellow-Striped Microbore Tubing", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3080-2026%22", "url": "https://recallledger.net/recalls/device-z-3080-2026-bd-alaris-pump-infusion-sets-10561554-10885403232565-50885403232563-b/"}, {"id": "fda-device-z-2985-2026", "source": "FDA", "category": "device", "recall_number": "Z-2985-2026", "title": "DuoGlide Short-Term Straight Dialysis Catheter recall (Bard Access Systems, Inc.)", "product": "DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150;  DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200;  DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240;  DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300;  DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120;  DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150;  DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200;  DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240;  Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200", "reason": "this is a downstream recall of class I recall RES 98777", "hazard_level": "Class I", "company": "Bard Access Systems, Inc.", "company_location": "Salt Lake City, UT, United States", "date": "2026-08-10", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "22,980", "codes": "REF/UDI-DI/Lot(Expiration): 5625150/801741042096/ REKS1082(8/31/2026), REKS2493(10/31/2026), REKU1654(10/31/2026), REKV2899(1/31/2027), REKX0416(3/31/2027), REKY1371(4/30/2027), REKZ0520(5/31/2027);  5625200/801741042102/ REKQ3365(8/31/2026), REKR0913(9/30/2026), REKR3442(9/30/2026), REKS3566(10/31/2026), REKT3039(11/30/2026), REKV0934(12/31/2026), REKW2112(1/31/2027), REKX1756(3/31/2027), REKY1379(4/30/2027), REKZ2330(5/31/2027), RELP1350(7/31/2027);  5625240/801741042119/ REKS1561(9/30/2026), REKU1624(12/31/2026), REKW1234(2/28/2027), REKY0255(4/30/2027), REKY2419(4/30/2027), RELP2149(7/31/2027);  5625300/801741042126/ REKQ1106(8/31/2026), REKS1554(10/31/2026), REKW1239(2/28/2027), REKY1363(4/30/2027), RELN2943(6/30/2027);  5626120/801741042133/ REKU1592(12/31/2026), REKW0662(2/28/2027), REKY2397(4/30/2027);  5626150/801741042140/ REKQ3359(8/31/2026), REKS3561(10/31/2026), REKW0658(2/28/2027), REKY1388(4/30/2027), RELP1359(7/31/2027);  5626200/801741042157/ REKW1244(2/28/2027), REKY0237(4/30/2027);  5626240/801741042164/ REKR2191(9/30/2026), REKU1680(12/31/2026), REKW1230(1/31/2027), REKY0250(4/30/2027);  5575150/  5766200/801741045714/ REKT1903(11/30/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2985-2026%22", "url": "https://recallledger.net/recalls/device-z-2985-2026-duoglide-short-term-straight-dialysis-catheter-ref-5625150-duoglid/"}, {"id": "fda-device-z-2984-2026", "source": "FDA", "category": "device", "recall_number": "Z-2984-2026", "title": "Power-Trialysis Short-Term Straight Dialysis Catheter recall (Bard Access Systems, Inc.)", "product": "Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150;   Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;   Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240;  Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300;  Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615120;  Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615150;  Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615200;   Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615240;  Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655120;   Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655150;   Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655200;  Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655240;   Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray, REF: 5605200G;   Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200G;   Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150G;    Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855150;  Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200;  Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855240;  Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855300;  Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865120;  Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150;  Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865200;  Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865240", "reason": "this is a downstream recall of class I recall RES 98777", "hazard_level": "Class I", "company": "Bard Access Systems, Inc.", "company_location": "Salt Lake City, UT, United States", "date": "2026-08-10", "report_date": "2026-09-23", "status": "Ongoing", "distribution": "US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "149521", "codes": "REF/UDI-DI/Lot(Expiration): 5605150/801741086953/ REKQ2236(08/31/2026), REKR0948(08/31/2026), REKR3422(09/30/2026), REKR3433(09/30/2026), REKS1563(10/31/2026), REKS3564(09/30/2026), REKS3559(10/31/2026), REKT0573(11/30/2026), REKT1722(09/30/2026), REKT3057(10/31/2026), REKU1678(12/31/2026), REKV0926(01/31/2027), REKW0664(02/28/2027), REKX0410(03/31/2027), REKX1755(03/31/2027), REKY2464(03/31/2027), REKZ2323(05/31/2027), RELN2937(06/30/2027);  5605200/801741086960/ REKQ3355(8/31/2026, REKQ3362(8/31/2026), REKR0756(9/30/2026), REKR2159(9/30/2026), REKR2214(9/30/2026), REKS1550(10/31/2026), REKS1559(10/31/2026), REKS2495(10/31/2026), REKT0576(10/31/2026), REKT0579(11/30/2026), REKT2201(11/30/2026), REKT3018(11/30/2026), REKU2636(12/31/2026), REKU3679(12/31/2026), REKV2415(12/31/2026), REKW2742(2/28/2027), REKX0576(3/31/2027), REKX2423(3/31/2027), REKZ0519(5/31/2027), RELN1850(6/30/2027);  5605240/801741086977/ REKQ3367(8/31/2026), REKR0762(8/31/2026), REKS3554(8/31/2026), REKT2178(11/30/2026), REKU3687(12/31/2026), REKW0663(2/28/2027), REKW2120(2/28/2027), REKX0561(12/31/2026), REKY1369(3/31/2027), REKZ0376(5/31/2027), RELN1835(6/30/2027);   5605300/801741086984/ REKR3428(9/30/2026), REKS2486(10/31/2026), REKT3038(11/30/2026), REKV1678(10/31/2026), REKW2736(1/31/2027), REKX3721(3/31/2027), REKY2472(4/30/2027);  5615120/801741075087/ REKR0770(9/30/2026), REKR2157(9/30/2026), REKT2999(11/30/2026), REKX1764(1/31/2027), REKZ0393(2/28/2027);  5615150/801741075094/ REKQ3350(8/31/2026), REKR2193(9/30/2026), REKS1070(10/31/2026), REKS2494(10/31/2026), REKT0570(11/30/2026), REKT2132(10/31/2026), REKU1247(10/31/2026), REKU3675(12/31/2026), REKV1674(12/31/2026), REKW1228(2/28/2027), REKW2108(1/31/2027), REKX2412(3/31/2027), REKY0262(3/31/2027), REKZ0396(5/31/2027), RELN0870(6/30/2027), RELP0317(7/31/2027);  5615200/801741075100/ REKQ1130(8/31/2026), REKQ3357(8/31/2026), REKR0905(9/30/2026), REKR2215(9/30/2026), REKS1083(10/31/2026), REKT1724(11/30/2026), REKU1255(12/31/2026), REKU3680(12/31/2026), REKV2897(1/31/2027), REKW2743(2/28/2027), REKX0413(12/31/2026), REKX3745(1/31/2027), REKY2418(4/30/2027), REKZ0377(5/31/2027), RELP0308(7/31/2027);  5615240/801741075117/ REKQ3364(8/31/2026), REKR3434(9/30/2026), REKU2632(12/31/2026), REKX0415(12/31/2026), REKY0249(3/31/2027), RELN2947(6/30/2027);  5655120/801741066054/ REKV0931(1/31/2027), REKX0578(3/31/2027), REKY2420(2/28/2027);  5655150/00801741066061/ REKR2161(9/30/2026), REKV0928(10/31/2026), REKX3746(3/31/2027), REKY2398(3/31/2027), RELP1351(7/31/2027);  5655200/801741066078/ REKQ3353(8/31/2026), REKR2150(9/30/2026), REKV1673(10/31/2026), REKW2116(1/31/2027), RELN0858(6/30/2027);  5655240/801741066085/ REKS2492(10/31/2026), REKX1759(2/28/2027), REKY0238(4/30/2027);  5605200G/801741100154/ REKQ2567(8/31/2026), REKV1675(1/31/2027), REKX2411(3/31/2027), REKZ2321(5/31/2027);  5855200G/801741107146/ REKS2190(10/31/2026), REKX2413(2/28/2027), REKY0258(4/30/2027), REKZ0385(5/31/2027);  5865150G/00801741107153/ REKQ2583(8/31/2026), REKY1373(4/30/2027)  5855150/801741107412/ REKR0766(9/30/2026), REKR2162(8/31/2026), REKS2499(10/31/2026), REKU2621(12/31/2026), REKW2723(1/31/2027), REKY0252(4/30/2027), REKY2469(4/30/2027), RELN2934(6/30/2027);  5855200/801741107160/ REKQ3347(8/31/2026), REKR2211(9/30/2026), REKS3567(8/31/2026), REKU2629(12/31/2026), REKW0656(1/31/2027), REKX0406(3/31/2027), REKY0246(4/30/2027), RELP0770(7/31/2027);  5855240/801741107177/ REKQ2576(8/31/2026), REKR3432(9/30/2026), REKU3683(10/31/2026) , REKW0667(2/28/2027), REKY0240(4/30/2027), REKY2412(3/31/2027), RELN0859(6/30/2027);  5855300/801741107184/ REKQ1117(8/31/2026), REKR2204(9/30/2026), REKU1254(12/31/2026), REKY1364(4/30/2027);  5865120/801741107191/ REKS3553(10/31/2026), REKU1626(12/31/2026), REKY0241(4/30/2027), RELN0881(6/30/2027);  5865150/801741107207/ REKQ1100(8/31/2026), REKS1552(10/31/2026), REKU1594(10/31/2026), REKV2895(1/31/2027), REKX3723(3/31/2027), REKZ0397(5/31/2027);  5865200/801741107214/ REKS1549(10/31/2026), REKV0941(12/31/2026), REKY1381(4/30/2027), RELN0861(6/30/2027);  5865240/801741107221/ REKS2488(10/31/2026), REKU1253(12/31/2026), REKW2113(1/31/2027), REKY1365(4/30/2027);", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2984-2026%22", "url": "https://recallledger.net/recalls/device-z-2984-2026-power-trialysis-short-term-straight-dialysis-catheter-ref-5605150/"}, {"id": "fda-food-h-1341-2026", "source": "FDA", "category": "food", "recall_number": "H-1341-2026", "title": "Alfalfa recall (International Sprout Holdings, Inc)", "product": "Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506", "reason": "Potential E. coli and Salmonella contamination", "hazard_level": "Class I", "company": "International Sprout Holdings, Inc", "company_location": "Cookeville, TN, United States", "date": "2026-08-23", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Wholesale consignees in 16 states: CA, FL, HI, IL, MA, MN, MO, MT, NY, OH, OR, PA, TN, SC, TX, UT; Puerto Rico; Canada, Mexico, Tahiti, and Venezuela", "states": ["CA", "FL", "HI", "IL", "MA", "MN", "MO", "MT", "NY", "OH", "OR", "PA", "PR", "SC", "TN", "TX", "UT"], "nationwide": false, "quantity": "43,799 lbs.", "codes": "ISS Lot # SAL2-24JB", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1341-2026%22", "url": "https://recallledger.net/recalls/food-h-1341-2026-alfalfa-net-weight-50-lbs-bag-product-of-usa-international-special/"}, {"id": "fda-food-h-1335-2026", "source": "FDA", "category": "food", "recall_number": "H-1335-2026", "title": "Prolon Everyday Apulian Almond & Cocoa Spread recall (L-Nutra Inc)", "product": "Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white label and gold screw on closure. UPC: 50040360530", "reason": "Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio.", "hazard_level": "Class II", "company": "L-Nutra Inc", "company_location": "Los Angeles, CA, United States", "date": "2026-08-07", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Product is sold exclusively from the recalling firm's online website nationwide.", "states": [], "nationwide": true, "quantity": "8,529 jars", "codes": "Lot code: L2755 Expiration: 02 Jan 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1335-2026%22", "url": "https://recallledger.net/recalls/food-h-1335-2026-prolon-everyday-apulian-almond-cocoa-spread-net-wt-8-47-oz-produc/"}, {"id": "fda-food-h-1334-2026", "source": "FDA", "category": "food", "recall_number": "H-1334-2026", "title": "Fannie May & XO Marshmallow Pixie S'mores Collection recall (Ferrero USA)", "product": "Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz", "reason": "Undeclared milk and pecans", "hazard_level": "Class II", "company": "Ferrero USA", "company_location": "North Canton, OH, United States", "date": "2026-08-14", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "IA, IL, IN, OH", "states": ["IA", "IL", "IN", "OH"], "nationwide": false, "quantity": "1488 retail units", "codes": "All best by codes that were sold 8/7/2026 to 8/14/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1334-2026%22", "url": "https://recallledger.net/recalls/food-h-1334-2026-fannie-may-xo-marshmallow-pixie-s-mores-collection-4-47oz/"}, {"id": "fda-food-h-1331-2026", "source": "FDA", "category": "food", "recall_number": "H-1331-2026", "title": "Crown Farms Dried Suri Cut recall (EURO FOODS GROUP USA NJ INC)", "product": "Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozen", "reason": "The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying.", "hazard_level": "Class I", "company": "EURO FOODS GROUP USA NJ INC", "company_location": "Totowa, NJ, United States", "date": "2026-08-01", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following states: VA, NY, NJ, MI", "states": ["MI", "NJ", "NY", "VA"], "nationwide": false, "quantity": "53 boxes", "codes": "BATCH NO: 130 EF, 146 EF SERIAL NUMBER: 5055192640140 PRODUCT CODE: 28DSUM", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1331-2026%22", "url": "https://recallledger.net/recalls/food-h-1331-2026-crown-farms-dried-suri-cut-200-gm-in-plastic-pack-25-packages-per-b/"}, {"id": "fda-food-h-1330-2026", "source": "FDA", "category": "food", "recall_number": "H-1330-2026", "title": "Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower recall (EXOTIQUE FOODS CANADA)", "product": "Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca Flour, Coconut Oil, Salt, White Pepper. Proudly Made in Indonesia. Imported for Exotique Foods, Inc. Toronto, ON - Canada.", "reason": "Undeclared Wheat.", "hazard_level": "Class I", "company": "EXOTIQUE FOODS CANADA", "company_location": "Etobicoke, Canada", "date": "2026-08-07", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Product was sold in the U.S.", "states": [], "nationwide": false, "quantity": "68 cases", "codes": "Best Before: 2026 AUGUST 31", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1330-2026%22", "url": "https://recallledger.net/recalls/food-h-1330-2026-momchipz-gluten-free-veggie-chips-broccoli-florets-cauliflower-net/"}, {"id": "fda-drug-d-0869-2026", "source": "FDA", "category": "drug", "recall_number": "D-0869-2026", "title": "0.9% Sodium Chloride Injection recall (B BRAUN MEDICAL INC)", "product": "0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.", "reason": "Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene", "hazard_level": "Class I", "company": "B BRAUN MEDICAL INC", "company_location": "Allentown, PA, United States", "date": "2026-08-19", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "201,472 total container", "codes": "Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0869-2026%22", "url": "https://recallledger.net/recalls/drug-d-0869-2026-0-9-sodium-chloride-injection-usp-100-ml-partial-fill-in-150-ml-pab/"}, {"id": "fda-drug-d-0865-2026", "source": "FDA", "category": "drug", "recall_number": "D-0865-2026", "title": "Epinephrine Injection recall (American Regent, Inc.)", "product": "Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01", "reason": "Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.", "hazard_level": "Class I", "company": "American Regent, Inc.", "company_location": "Shirley, NY, United States", "date": "2026-08-11", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Nationwide within the U.S.A", "states": [], "nationwide": true, "quantity": "31,935 30mL-vials", "codes": "Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0865-2026%22", "url": "https://recallledger.net/recalls/drug-d-0865-2026-epinephrine-injection-usp-30-mg-30-ml-1mg-ml-30-ml-multiple-dose/"}, {"id": "fda-drug-d-0850-2026", "source": "FDA", "category": "drug", "recall_number": "D-0850-2026", "title": "Dextrose Injection recall (Baxter Healthcare Corporation)", "product": "Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06", "reason": "Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.", "hazard_level": "Class I", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-17", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "U.S. Nationwide.", "states": [], "nationwide": true, "quantity": "606 bags", "codes": "Lot #: Y495066, Exp. Date July 31, 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0850-2026%22", "url": "https://recallledger.net/recalls/drug-d-0850-2026-dextrose-injection-usp-70-2000-ml-bags-rx-only-baxter-healthcar/"}, {"id": "fda-drug-d-0836-2026", "source": "FDA", "category": "drug", "recall_number": "D-0836-2026", "title": "Fluphenazine Hydrochloride Tablets recall (Ajanta Pharma USA Inc)", "product": "Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only,  Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.", "reason": "Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.", "hazard_level": "Class III", "company": "Ajanta Pharma USA Inc", "company_location": "Bridgewater, NJ, United States", "date": "2026-08-25", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Nationwide within the U.S", "states": [], "nationwide": true, "quantity": "403,200 tablets", "codes": "Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0836-2026%22", "url": "https://recallledger.net/recalls/drug-d-0836-2026-fluphenazine-hydrochloride-tablets-usp-1mg-100-count-bottles-rx-on/"}, {"id": "fda-drug-d-0835-2026", "source": "FDA", "category": "drug", "recall_number": "D-0835-2026", "title": "Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution recall (ImprimisRx NJ LLC)", "product": "Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10", "reason": "Subpotent Drug", "hazard_level": "Class III", "company": "ImprimisRx NJ LLC", "company_location": "Ledgewood, NJ, United States", "date": "2026-08-24", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "772 bottles", "codes": "Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0835-2026%22", "url": "https://recallledger.net/recalls/drug-d-0835-2026-povidone-iodine-1-25-proparacaine-hcl-0-5-ophthalmic-solution-10/"}, {"id": "fda-device-z-3136-2026", "source": "FDA", "category": "device", "recall_number": "Z-3136-2026", "title": "Citric Complete Liquid Citric Acid Concentrate    REF: LC+200-D recall (Nipro Renal Soultions USA, Corporation)", "product": "Citric Complete Liquid Citric Acid Concentrate    REF: LC+200-D,LC+201, LC+225(45X)", "reason": "Hemodialysis concentrates contain high endotoxin levels", "hazard_level": "Class II", "company": "Nipro Renal Soultions USA, Corporation", "company_location": "Lewisberry, PA, United States", "date": "2026-08-05", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.", "states": ["FL", "GA", "IL", "MD", "MI", "NC", "NJ", "NV", "OH", "PA"], "nationwide": true, "quantity": "100 drums/1072 cases", "codes": "LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3136-2026%22", "url": "https://recallledger.net/recalls/device-z-3136-2026-citric-complete-liquid-citric-acid-concentrate-ref-lc-200-d-lc-201/"}, {"id": "fda-device-z-3135-2026", "source": "FDA", "category": "device", "recall_number": "Z-3135-2026", "title": "Citric Complete Dry Citric Acid Concentrate    REF: DCA+200-25 & DCA+203-25 recall (Nipro Renal Soultions USA, Corporation)", "product": "Citric Complete Dry Citric Acid Concentrate    REF: DCA+200-25 & DCA+203-25", "reason": "Hemodialysis concentrates contain high endotoxin levels", "hazard_level": "Class II", "company": "Nipro Renal Soultions USA, Corporation", "company_location": "Lewisberry, PA, United States", "date": "2026-08-05", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.", "states": ["FL", "GA", "IL", "MD", "MI", "NC", "NJ", "NV", "OH", "PA"], "nationwide": true, "quantity": "7,770 cases", "codes": "DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3135-2026%22", "url": "https://recallledger.net/recalls/device-z-3135-2026-citric-complete-dry-citric-acid-concentrate-ref-dca-200-25-dca-2/"}, {"id": "fda-device-z-3134-2026", "source": "FDA", "category": "device", "recall_number": "Z-3134-2026", "title": "MedicaLyte Bicarbonate Powder    REF: DB+201-2.1 recall (Nipro Renal Soultions USA, Corporation)", "product": "MedicaLyte Bicarbonate Powder    REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))", "reason": "Hemodialysis concentrates contain high endotoxin levels", "hazard_level": "Class II", "company": "Nipro Renal Soultions USA, Corporation", "company_location": "Lewisberry, PA, United States", "date": "2026-08-05", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.", "states": ["FL", "GA", "IL", "MD", "MI", "NC", "NJ", "NV", "OH", "PA"], "nationwide": true, "quantity": "2,327 cases", "codes": "DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3134-2026%22", "url": "https://recallledger.net/recalls/device-z-3134-2026-medicalyte-bicarbonate-powder-ref-db-201-2-1-45x-and-db-201-25-3/"}, {"id": "fda-device-z-3133-2026", "source": "FDA", "category": "device", "recall_number": "Z-3133-2026", "title": "MedicaLyte Liquid Bicarbonate Concentrate    REF: BC-100 and BC+201 recall (Nipro Renal Soultions USA, Corporation)", "product": "MedicaLyte Liquid Bicarbonate Concentrate    REF: BC-100 and BC+201", "reason": "Hemodialysis concentrates contain high endotoxin levels", "hazard_level": "Class II", "company": "Nipro Renal Soultions USA, Corporation", "company_location": "Lewisberry, PA, United States", "date": "2026-08-05", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.", "states": ["FL", "GA", "IL", "MD", "MI", "NC", "NJ", "NV", "OH", "PA"], "nationwide": true, "quantity": "3,286 cases", "codes": "BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3133-2026%22", "url": "https://recallledger.net/recalls/device-z-3133-2026-medicalyte-liquid-bicarbonate-concentrate-ref-bc-100-and-bc-201/"}, {"id": "fda-device-z-3113-2026", "source": "FDA", "category": "device", "recall_number": "Z-3113-2026", "title": "Getinge PVC Thoracic Catheter recall (Atrium Medical Corporation)", "product": "Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;  Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);", "reason": "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.", "hazard_level": "Class II", "company": "Atrium Medical Corporation", "company_location": "Merrimack, NH, United States", "date": "2026-08-07", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "256", "codes": "1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891;  3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3113-2026%22", "url": "https://recallledger.net/recalls/device-z-3113-2026-getinge-pvc-thoracic-catheter-firm-pvc-straight-10-per-case-size-m/"}, {"id": "fda-device-z-3112-2026", "source": "FDA", "category": "device", "recall_number": "Z-3112-2026", "title": "Getinge PVC Thoracic Catheter recall (Atrium Medical Corporation)", "product": "Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case;  Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);", "reason": "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.", "hazard_level": "Class II", "company": "Atrium Medical Corporation", "company_location": "Merrimack, NH, United States", "date": "2026-08-07", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "2533", "codes": "1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852;  2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855;  3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859;  4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3112-2026%22", "url": "https://recallledger.net/recalls/device-z-3112-2026-getinge-pvc-thoracic-catheter-soft-pvc-right-angle-10-per-case-siz/"}, {"id": "fda-device-z-3111-2026", "source": "FDA", "category": "device", "recall_number": "Z-3111-2026", "title": "Getinge PVC Thoracic Catheter recall (Atrium Medical Corporation)", "product": "Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;  Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);", "reason": "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.", "hazard_level": "Class II", "company": "Atrium Medical Corporation", "company_location": "Merrimack, NH, United States", "date": "2026-08-07", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "3618", "codes": "1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878;  2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835;  3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681;  4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840;  5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3111-2026%22", "url": "https://recallledger.net/recalls/device-z-3111-2026-getinge-pvc-thoracic-catheter-soft-pvc-straight-10-per-case-size-m/"}, {"id": "fda-device-z-3110-2026", "source": "FDA", "category": "device", "recall_number": "Z-3110-2026", "title": "Product Name: DermaV Laser System  Model/Catalog Number: DermaV    Medical laser... recall (Lutronic Corporation)", "product": "Product Name: DermaV Laser System  Model/Catalog Number: DermaV    Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment", "reason": "Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.", "hazard_level": "Class II", "company": "Lutronic Corporation", "company_location": "Goyang, Korea (the Republic of)", "date": "2026-08-06", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada and European Union.", "states": [], "nationwide": true, "quantity": "1065", "codes": "Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A019, DV025A020, DV025A021, DV025A022, DV025B011, DV025B012, DV025B013, DV025B014, DV025B015, DV025D006, DV025D007, DV025D008, DV025D009, DV025D010, DV025E003, DV025E004, DV025E005, DV025E006, DV025E007, DV025E008, DV025E009, DV025E010, DV025E011, DV025E012, DV025E013, DV025E014, DV025E016, DV025E017, DV025F012, DV025F013, DV025F014, DV025F015, DV025F016, DV025G011, DV025G012, DV025G013, DV025G014, DV025G015, DV025G016, DV025G017, DV025G018, DV025G019, DV025G020, DV025J021, DV025J022, DV025J023, DV025J025, DV025J026, DV025J027, DV025J028, DV025J034, DV025J035, DV025J036, DV025J037, DV025J038, DV025J040,  DV025K018, DV025K019, DV025K020, DV025K021, DV025K023, DV025K024, DV025K025, DV025K027, DV025M031, DV025M032, DV025M033, DV025M034, DV026B001, DV026B002, DV026B003, DV026B004, DV026B005, DV026B010, DV026B014, DV026B015, DV026B016, DV026B017, DV026B018, DV026C006, DV026C007, DV026C008, DV026C009, DV026C010, DV025M035", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3110-2026%22", "url": "https://recallledger.net/recalls/device-z-3110-2026-product-name-dermav-laser-system-model-catalog-number-dermav-med/"}, {"id": "fda-device-z-3090-2026", "source": "FDA", "category": "device", "recall_number": "Z-3090-2026", "title": "Bravo CF capsule delivery device recall (Given Imaging Ltd.)", "product": "Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635,     Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636.  Used to attach a pH monitoring capsule to the esophagus.", "reason": "Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.", "hazard_level": "Class I", "company": "Given Imaging Ltd.", "company_location": "Yokne'Am Ilit, Israel", "date": "2026-08-06", "report_date": "2026-09-16", "status": "Ongoing", "distribution": "Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "127,416", "codes": "Product Number FGS-0635 UDI-DI (GTIN) 07290101369707  Product Number FGS-0636 UDI-DI (GTIN) 07290101369714  Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3090-2026%22", "url": "https://recallledger.net/recalls/device-z-3090-2026-bravo-cf-capsule-delivery-device-5-pack-product-number-fgs-0635/"}, {"id": "fda-food-h-1328-2026", "source": "FDA", "category": "food", "recall_number": "H-1328-2026", "title": "Frankie's Organic Plant-Based Puffs Vegan Cheddar recall (Marina Del Rey Foods inc.)", "product": "Frankie's Organic Plant-Based Puffs Vegan Cheddar, NET WT. 4 oz. (113 g). Product is packaged into flexible plastic bag, UPC 816929000119. Sold wholesale: 12 retail units/ case", "reason": "Product tested positive for undeclared milk.", "hazard_level": "Class I", "company": "Marina Del Rey Foods inc.", "company_location": "Laval, N/A, Canada", "date": "2026-08-05", "report_date": "2026-09-09", "status": "Terminated", "distribution": "The product can be found at PCC Markets in WA and Earth Fare Stores in FL & SC, as well as select independent retailers in these regions. Frankie's Organic is working with 3 distribution centers that any remaining inventory is removed from distribution (GA, OR).", "states": ["FL", "GA", "OR", "SC", "WA"], "nationwide": false, "quantity": "322 cases (12-4oz units/case)", "codes": "Best If Used By: 05 16 2027 and Best If Used By: 07 03 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1328-2026%22", "url": "https://recallledger.net/recalls/food-h-1328-2026-frankie-s-organic-plant-based-puffs-vegan-cheddar-net-wt-4-oz-113/"}, {"id": "fda-food-h-1319-2026", "source": "FDA", "category": "food", "recall_number": "H-1319-2026", "title": "Organic Cheddar Type Seasoning recall (Savor Seasonings LLC)", "product": "Organic Cheddar Type Seasoning, NET WT: 50 lbs. Product is packaged in bulk poly-lined paper bag. Savor Seasonings, LLC. 4292 Armstrong Boulevard Batavia, OH 45103.  Product distribution: 218 (50-lb) bags + 2 partial bags (27-lb and 34-lb, one from each lot respectively).", "reason": "Product tested positive for undeclared milk allergen.", "hazard_level": "Class I", "company": "Savor Seasonings LLC", "company_location": "Batavia, OH, United States", "date": "2026-08-07", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "1 consignee in Canada", "states": [], "nationwide": false, "quantity": "10,961 lbs", "codes": "Product Number: OCCHD00007-005 Lot: 11562, Batch: 1 and 2, Use By: 20270127 Lot: 11609, Batch: 1, 2, and 3, Use By: 20270211", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1319-2026%22", "url": "https://recallledger.net/recalls/food-h-1319-2026-organic-cheddar-type-seasoning-net-wt-50-lbs-product-is-packaged-in/"}, {"id": "fda-food-h-1309-2026", "source": "FDA", "category": "food", "recall_number": "H-1309-2026", "title": "THE HAMPTON GROCER brand recall (THE HAMPTON GROCER)", "product": "THE HAMPTON GROCER brand; Lacnola; SMALL BATCH LACTATION GRANOLA, 8oz, stand up pouches; NUTRIENT DENSE INGREDIENTS + MORINGA; SUPPORTS + PROMOTES HEALTHY LACTATION; INGREDIENTS Organic Gluten Free Oats Organic Maple Syrup Organic Pumpkin Seeds Organic Coconut Oil Almond Butter Almonds Organic Coconut Sugar Chocolate Chips (Cane Sugar, Unsweetened Chocolate, Cocoa Butter) Organic Ground Flaxseed Moringa Leaf Powder Pure Vanilla Extract (Water, Alcohol, Vanilla Bean Extractives) Cream of Tartar Baking Soda Salt; CONTAINS: TREE NUTS (ALMOND, COCONUTS); DISTRIBUTED BY: The Hampton Grocer Inc. Montauk, NY; MADE IN A FACILITY THAT PROCESSES TREE NUTS, PEANUTS, SESAME, AND SOY; UPC 8 50035 32455 4", "reason": "Product may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "THE HAMPTON GROCER", "company_location": "Montauk, NY, United States", "date": "2026-08-14", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "4,059 units", "codes": "Lot Code HGLC-102125 with expiration date 21OCT2026 Lot Code HGLC-021326 with expiration date 13FEB2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1309-2026%22", "url": "https://recallledger.net/recalls/food-h-1309-2026-the-hampton-grocer-brand-lacnola-small-batch-lactation-granola-8oz/"}, {"id": "fda-food-h-1308-2026", "source": "FDA", "category": "food", "recall_number": "H-1308-2026", "title": "Weis recall (WEIS MARKETS, INC.)", "product": "Weis  (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon, Gallon, plastic jug. 6  1/2 - gallon jugs per crate.", "reason": "Product has high patulin levels", "hazard_level": "Class II", "company": "WEIS MARKETS, INC.", "company_location": "Sunbury, PA, United States", "date": "2026-08-06", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "The recalled product was distributed to the State of PA.", "states": [], "nationwide": false, "quantity": "Pints : 360 , 1/2 Gallon : 855,  Gallon - 765", "codes": "pull date/expiration date, etc.   7/17/26, 8/4/26, 8/13/26, 8/28/26, 9/4/26, 9/11/26, 9/30/26", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1308-2026%22", "url": "https://recallledger.net/recalls/food-h-1308-2026-weis-fresh-from-the-orchard-pasteurized-apple-cider-contains-100/"}, {"id": "fda-food-h-1307-2026", "source": "FDA", "category": "food", "recall_number": "H-1307-2026", "title": "Prince PAN DE MANTECA recall (Prince Bakery Inc)", "product": "Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED AND/OR CANOLA OILS) DOUGH CONDITIONER [WHEY, MILK], CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE, HYDROCHLORIDE, POTASSIUM BROMATE), DEXTROSE, MONO-DIGYLCERIDES, SUGAR, GUAR GUM, MALT BARLEY FLOUR, ETHOOXYLATED MONODIGLYCERIDES, DIACETYL TARTARIC ACID ESTERS OF MONO-DIGLYCERIDES [DATEM], CORN SYRUP SOLIDS, POTASSIUM BROMATE, ENZYME, POLYSORBATE 60, SOY OILL, L-CYSTEINE, PROPIONIC ACID, SODIUM PROPIONATE (A PRESERVATIVE), PHOSPHORIC ACID.; CONTAINS: WHEAT AND SOY; UPC 8 93601 00102 2; packaged in blue, yellow, and green bag.", "reason": "Milk is not declared in the Contains statement.", "hazard_level": "Class II", "company": "Prince Bakery Inc", "company_location": "Bronx, NY, United States", "date": "2026-08-13", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "New York.", "states": ["NY"], "nationwide": false, "quantity": "150 units (total)", "codes": "No codes", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1307-2026%22", "url": "https://recallledger.net/recalls/food-h-1307-2026-prince-pan-de-manteca-spanish-style-net-weight-8-oz-227g-ingredi/"}, {"id": "fda-food-h-1306-2026", "source": "FDA", "category": "food", "recall_number": "H-1306-2026", "title": "Prince Sesame FRENCH BREAD recall (Prince Bakery Inc)", "product": "Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g); INGREDIENTS: ENRICHED BLEACHED FLOUR, (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED, AND/OR CANOLA OILS), DOUGH CONDITIONER [WHEY (MILK), CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE, HYDROCHLORIDE, POTASSIUM BROMATE] DEXTROSE, MONO-DIGLYCERIDES, SUGAR, GUAR GUM, MALT BARLEY FLOUR, ETHOXYLATED MONO-DIGLYCERIDES (DATEM), CORN SYRUP SOLIDS, POTASSIUM BROMATE, ENZYME, POLYSORBATE 60, SOY OIL, L-CYSTEINE, PROPIONIC ACID, SODIUM PROPIONATE (A PRESERVATIVE), PHOSPHORIC ACID. MAY CONTAIN SESAME SEEDS; UPC: 8 93601 00100 8; packaged in red and yellow bag.", "reason": "Sesame is not declared in the ingredient statement but is declared in the statement of identity.", "hazard_level": "Class III", "company": "Prince Bakery Inc", "company_location": "Bronx, NY, United States", "date": "2026-08-13", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "New York.", "states": ["NY"], "nationwide": false, "quantity": "150 units (total)", "codes": "No codes", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1306-2026%22", "url": "https://recallledger.net/recalls/food-h-1306-2026-prince-sesame-french-bread-long-french-net-wt-10-oz-284g-ingredi/"}, {"id": "fda-food-h-1305-2026", "source": "FDA", "category": "food", "recall_number": "H-1305-2026", "title": "Prince ITALIAN BREAD recall (Prince Bakery Inc)", "product": "Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED AND/OR CANOLA OILS), DOUGH CONDITIONER [WHEY (MILK), CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE HYDROCHLORIDE, POTASSIUM BROMATE] DEXTROSE, MONO-DIGLCYERIDES, DIACETYL, TARTARIC ACID ESTERS OF MONO-DIGLYCERIDES (DATEM), CORN SYRUP SOLIDS, POTASSIUM BROMATE, ENZYME, POLYSORBATE 60, SOY OIL, L CYSTEINE, PROPIONIC ACID, SODIUM PROPIONATE (A PRESERVATIVE), PHOSPHORIC ACID. MAY CONTAIN SESAME SEEDS; UPC 8 93601 00104 6; green and yellow bag.  Both Large Italian and French breads are packaged in the same bags.", "reason": "Sesame is not declared in the ingredient statement but is declared in the statement of identity.", "hazard_level": "Class III", "company": "Prince Bakery Inc", "company_location": "Bronx, NY, United States", "date": "2026-08-13", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "New York.", "states": ["NY"], "nationwide": false, "quantity": "150 units (total)", "codes": "No codes", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1305-2026%22", "url": "https://recallledger.net/recalls/food-h-1305-2026-prince-italian-bread-sesame-italian-french-bread-large-net-weigh/"}, {"id": "fda-food-h-1304-2026", "source": "FDA", "category": "food", "recall_number": "H-1304-2026", "title": "Prince ITALIAN BREAD recall (Prince Bakery Inc)", "product": "Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED, AND/OR CANOLA OILS) DOUGH CONDITIONER [WHEY MILK], CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE, HYDROCHLORIDE, POTASSIUM BROMATE), DEXTROSE, MONO-DIGLYCERIDES, SUGAR, GUAR GUM, MALT BARLEY FLOUR, ETHOXYLATED MONO-DIGLYCERIDES, DIACETYL TARTARIC ACID ESTERS OF MONO-DIGLYCERIDES [DATEM], CORN SYRUP SOLIDS, POTASSIUM BROMATE, ENZYME, POLYSORBATE 60, SOY OIL, L. CYSTEINE, PROPRIONIC ACID, SODIUM PROPIONATE (A PRESERVATIVE), PHOSPHORIC ACID. MAY CONTAIN SESAME SEEDS; UPC 8 93601 00101 5; red and yellow bag", "reason": "Sesame is not declared in the ingredient statement but is declared in the statement of identity.", "hazard_level": "Class III", "company": "Prince Bakery Inc", "company_location": "Bronx, NY, United States", "date": "2026-08-13", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "New York.", "states": ["NY"], "nationwide": false, "quantity": "150 units (total)", "codes": "No codes", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1304-2026%22", "url": "https://recallledger.net/recalls/food-h-1304-2026-prince-italian-bread-sesame-net-weight-8-oz-227g-ingredients-en/"}, {"id": "fda-food-h-1303-2026", "source": "FDA", "category": "food", "recall_number": "H-1303-2026", "title": "Item #DIPSAU0205RFS Salsa Autentica 5 lb. packaged in round plastic container. recall (Ron's Home Style Foods, Inc.)", "product": "Item #DIPSAU0205RFS Salsa Autentica 5 lb. packaged in round plastic container.", "reason": "Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "Ron's Home Style Foods, Inc.", "company_location": "Houston, TX, United States", "date": "2026-08-06", "report_date": "2026-09-09", "status": "Terminated", "distribution": "AR, OK, TX", "states": ["AR", "OK", "TX"], "nationwide": false, "quantity": "2270 lbs. (total)", "codes": "61890047, Use-By Date 8/27/2026; 61960049, Use-By Date 9/3/2026; 62030033, Use-By Date 9/10/2026; 61900075, Use-By Date 8/28/2026; 61970088, Use-By Date 9/4/2026; 62110071, Use-By Date 9/18/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1303-2026%22", "url": "https://recallledger.net/recalls/food-h-1303-2026-item-dipsau0205rfs-salsa-autentica-5-lb-packaged-in-round-plastic-co/"}, {"id": "fda-food-h-1302-2026", "source": "FDA", "category": "food", "recall_number": "H-1302-2026", "title": "Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic container. recall (Ron's Home Style Foods, Inc.)", "product": "Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic container.", "reason": "Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella", "hazard_level": "Class I", "company": "Ron's Home Style Foods, Inc.", "company_location": "Houston, TX, United States", "date": "2026-08-06", "report_date": "2026-09-09", "status": "Terminated", "distribution": "AR, OK, TX", "states": ["AR", "OK", "TX"], "nationwide": false, "quantity": "2270 lbs. (total)", "codes": "61890037, Use-By Date 8/5/2026; 62080088, Use-By Date 8/24/2026; 62110070, Use-By Date 8/27/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1302-2026%22", "url": "https://recallledger.net/recalls/food-h-1302-2026-item-dippic0205rfs-pico-de-gallo-5-lb-packaged-in-round-plastic-cont/"}, {"id": "fda-drug-d-0851-2026", "source": "FDA", "category": "drug", "recall_number": "D-0851-2026", "title": "Glutathione 200 mg/mL recall (OPTIMAL BALANCE PHARMACY)", "product": "Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only,  Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090", "reason": "Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.", "hazard_level": "Class I", "company": "OPTIMAL BALANCE PHARMACY", "company_location": "Houston, TX, United States", "date": "2026-08-05", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "USA Nationwide.", "states": [], "nationwide": true, "quantity": "53 vials", "codes": "Lot#: LG342009076, Beyond Use Date: 10/4/26", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0851-2026%22", "url": "https://recallledger.net/recalls/drug-d-0851-2026-glutathione-200-mg-ml-30-ml-sterile-multidose-vial-each-vial-contain/"}, {"id": "fda-drug-d-0849-2026", "source": "FDA", "category": "drug", "recall_number": "D-0849-2026", "title": "0.9% Sodium Chloride Injection USP 500 mL recall (Baxter Healthcare Corporation)", "product": "0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03", "reason": "Presence of particulate matter: Particulates identified as fiberglass", "hazard_level": "Class I", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-17", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Natonwide in the USA", "states": [], "nationwide": false, "quantity": "145,464 500mL bags", "codes": "Lot: Y495523, Y495523A, Exp 31-Oct-2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0849-2026%22", "url": "https://recallledger.net/recalls/drug-d-0849-2026-0-9-sodium-chloride-injection-usp-500-ml-viaflex-plastic-containers/"}, {"id": "fda-drug-d-0847-2026", "source": "FDA", "category": "drug", "recall_number": "D-0847-2026", "title": "Prasugrel HCI recall (Golden State Medical Supply Inc.)", "product": "Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.", "reason": "Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution", "hazard_level": "Class II", "company": "Golden State Medical Supply Inc.", "company_location": "Camarillo, CA, United States", "date": "2026-08-21", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "6791 30-count bottles", "codes": "Lot # GS062298, Exp Date: 09/30/ 2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0847-2026%22", "url": "https://recallledger.net/recalls/drug-d-0847-2026-prasugrel-hci-tablets-usp-10mg-30-count-bottle-rx-only-marketed/"}, {"id": "fda-drug-d-0840-2026", "source": "FDA", "category": "drug", "recall_number": "D-0840-2026", "title": "Buprenorphine Sublingual Tablets recall (American Health Packaging)", "product": "Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).", "reason": "Labeling: Label Mix-up", "hazard_level": "Class III", "company": "American Health Packaging", "company_location": "Columbus, OH, United States", "date": "2026-08-19", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "10,953 cartons.", "codes": "Lot # 1030023, Exp Date: 06/30/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0840-2026%22", "url": "https://recallledger.net/recalls/drug-d-0840-2026-buprenorphine-sublingual-tablets-c-iii-2-mg-30-tablets-3x10-rx/"}, {"id": "fda-drug-d-0839-2026", "source": "FDA", "category": "drug", "recall_number": "D-0839-2026", "title": "Prasugrel Tablets recall (Mylan Pharmaceuticals Inc)", "product": "Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.", "reason": "Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria", "hazard_level": "Class II", "company": "Mylan Pharmaceuticals Inc", "company_location": "Morgantown, WV, United States", "date": "2026-08-17", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Nationwide within the U.S", "states": [], "nationwide": true, "quantity": "47,662 bottles", "codes": "Lot #: 3225272, Exp. September 30, 2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0839-2026%22", "url": "https://recallledger.net/recalls/drug-d-0839-2026-prasugrel-tablets-usp-10mg-rx-only-30-tablets-in-each-bottle-manu/"}, {"id": "fda-drug-d-0838-2026", "source": "FDA", "category": "drug", "recall_number": "D-0838-2026", "title": "Revcovi recall (Chiesi USA, Inc.)", "product": "Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518,  NDC 10122-502-01", "reason": "Failed Stability Specifications: Out of specification stability result for the protein concentration profile.", "hazard_level": "Class III", "company": "Chiesi USA, Inc.", "company_location": "Cary, NC, United States", "date": "2026-08-19", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "MO, TN", "states": ["MO", "TN"], "nationwide": false, "quantity": "3,002 vials", "codes": "Lot#: 1221973, Exp 3/24/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2026%22", "url": "https://recallledger.net/recalls/drug-d-0838-2026-revcovi-elapegademase-lvlr-injection-2-4mg-1-5ml-1-6-mg-ml-singl/"}, {"id": "fda-drug-d-0837-2026", "source": "FDA", "category": "drug", "recall_number": "D-0837-2026", "title": "2% Chlorhexidine Gluconate* Cloth recall (Sage Products, LLC)", "product": "2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.  NDC: 53462-705-26", "reason": "Cross Contamination with Other Products", "hazard_level": "Class II", "company": "Sage Products, LLC", "company_location": "Cary, IL, United States", "date": "2026-08-18", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "165,536 packages", "codes": "Lot 108491 with case sequence numbers 14841 through 20013.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0837-2026%22", "url": "https://recallledger.net/recalls/drug-d-0837-2026-2-chlorhexidine-gluconate-cloth-non-sterile-6-disposable-cloths-s/"}, {"id": "fda-drug-d-0834-2026", "source": "FDA", "category": "drug", "recall_number": "D-0834-2026", "title": "traZODone Hydrochloride Tablets recall (Teva Pharmaceuticals USA, Inc)", "product": "traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01", "reason": "Presence of Foreign Tablets/Capsules", "hazard_level": "Class II", "company": "Teva Pharmaceuticals USA, Inc", "company_location": "Parsippany, NJ, United States", "date": "2026-08-24", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "U.S. Nationwide", "states": [], "nationwide": true, "quantity": "175,392 bottles", "codes": "Lot: 1394026, Exp. 02/2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2026%22", "url": "https://recallledger.net/recalls/drug-d-0834-2026-trazodone-hydrochloride-tablets-usp-50-mg-rx-only-100-tablets-man/"}, {"id": "fda-drug-d-0833-2026", "source": "FDA", "category": "drug", "recall_number": "D-0833-2026", "title": "Trokendi XR recall (Supernus Pharmaceuticals, Inc.)", "product": "Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.", "reason": "Failed dissolution specifications.", "hazard_level": "Class III", "company": "Supernus Pharmaceuticals, Inc.", "company_location": "Rockville, MD, United States", "date": "2026-08-31", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "11304 bottles", "codes": "Lot# 2145283, Exp Date: 31-Mar-2030.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0833-2026%22", "url": "https://recallledger.net/recalls/drug-d-0833-2026-trokendi-xr-topiramate-extended-release-capsules-50-mg-30-capsule/"}, {"id": "fda-drug-d-0830-2026", "source": "FDA", "category": "drug", "recall_number": "D-0830-2026", "title": "Carton label: Mycophenolate Mofetil for injection recall (Mylan Pharmaceuticals Inc)", "product": "Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81.  Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.", "reason": "Failed Dissolution Specifications", "hazard_level": "Class II", "company": "Mylan Pharmaceuticals Inc", "company_location": "Morgantown, WV, United States", "date": "2026-08-26", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "U.S. Nationwide", "states": [], "nationwide": true, "quantity": "11,336 units", "codes": "Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0830-2026%22", "url": "https://recallledger.net/recalls/drug-d-0830-2026-carton-label-mycophenolate-mofetil-for-injection-usp-500-mg-vial-s/"}, {"id": "fda-drug-d-0829-2026", "source": "FDA", "category": "drug", "recall_number": "D-0829-2026", "title": "Broadway Joe's Pain Cream recall (Lexia LLC)", "product": "Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4", "reason": "CGMP Deviations: Potential contamination of raw material", "hazard_level": "Class II", "company": "Lexia LLC", "company_location": "Franklin, TN, United States", "date": "2026-08-21", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Distributed in the state of Colorado (US).", "states": ["CO"], "nationwide": false, "quantity": "1,200 4 oz-Jar", "codes": "Lot #: T1110, Exp: 1/7/2027;  T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0829-2026%22", "url": "https://recallledger.net/recalls/drug-d-0829-2026-broadway-joe-s-pain-cream-3000-gm-cbd-histamine-dihydrochloride-0-0/"}, {"id": "fda-drug-d-0828-2026", "source": "FDA", "category": "drug", "recall_number": "D-0828-2026", "title": "Broadway Joe's Pain Cream recall (Lexia LLC)", "product": "Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil,  2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7", "reason": "CGMP Deviations: Potential contamination of raw material", "hazard_level": "Class II", "company": "Lexia LLC", "company_location": "Franklin, TN, United States", "date": "2026-08-21", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Distributed in the state of Colorado (US).", "states": ["CO"], "nationwide": false, "quantity": "2,400 2 oz-jars", "codes": "Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0828-2026%22", "url": "https://recallledger.net/recalls/drug-d-0828-2026-broadway-joe-s-pain-cream-histamine-dihydrochloride-0-025-1500mg/"}, {"id": "fda-drug-d-0826-2026", "source": "FDA", "category": "drug", "recall_number": "D-0826-2026", "title": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall (Allies Group Inc.)", "product": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853", "reason": "Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.", "hazard_level": "Class II", "company": "Allies Group Inc.", "company_location": "Wilmington, DE, United States", "date": "2026-08-14", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Nationwide within the U.S.A", "states": [], "nationwide": true, "quantity": "2,149 90mL-Tubes", "codes": "Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0826-2026%22", "url": "https://recallledger.net/recalls/drug-d-0826-2026-the-one-spf-50-invisible-sunscreen-gel-avobenzone-3-homosalate-7/"}, {"id": "fda-drug-d-0825-2026", "source": "FDA", "category": "drug", "recall_number": "D-0825-2026", "title": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall (Allies Group Inc.)", "product": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC  8 885014 074733", "reason": "Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.", "hazard_level": "Class II", "company": "Allies Group Inc.", "company_location": "Wilmington, DE, United States", "date": "2026-08-14", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Nationwide within the U.S.A", "states": [], "nationwide": true, "quantity": "23,941, 20mL-Tube", "codes": "Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0825-2026%22", "url": "https://recallledger.net/recalls/drug-d-0825-2026-the-one-spf-50-invisible-sunscreen-gel-avobenzone-3-homosalate-7/"}, {"id": "fda-drug-d-0824-2026", "source": "FDA", "category": "drug", "recall_number": "D-0824-2026", "title": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall (Allies Group Inc.)", "product": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293", "reason": "Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.", "hazard_level": "Class II", "company": "Allies Group Inc.", "company_location": "Wilmington, DE, United States", "date": "2026-08-14", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Nationwide within the U.S.A", "states": [], "nationwide": true, "quantity": "27,492 3mL Sachets", "codes": "Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0824-2026%22", "url": "https://recallledger.net/recalls/drug-d-0824-2026-the-one-spf-50-invisible-sunscreen-gel-avobenzone-3-homosalate-7/"}, {"id": "fda-drug-d-0823-2026", "source": "FDA", "category": "drug", "recall_number": "D-0823-2026", "title": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL recall (Allies Group Inc.)", "product": "THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. 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Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.", "hazard_level": "Class II", "company": "Boston Scientific Corporation", "company_location": "Saint Paul, MN, United States", "date": "2026-08-06", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "UDI-DI: 00802526613852", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3083-2026%22", "url": "https://recallledger.net/recalls/device-z-3083-2026-lux-dx-lux-dx-ii-lux-dx-ii-insertable-cardiac-monitor-system-serve/"}, {"id": "fda-device-z-3082-2026", "source": "FDA", "category": "device", "recall_number": "Z-3082-2026", "title": "LUX-Dx recall (Boston Scientific Corporation)", "product": "LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)", "reason": "There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). 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Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.", "hazard_level": "Class II", "company": "Boston Scientific Corporation", "company_location": "Saint Paul, MN, United States", "date": "2026-08-06", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "UDI-DI: 00802526613838", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3081-2026%22", "url": "https://recallledger.net/recalls/device-z-3081-2026-lux-dx-lux-dx-ii-lux-dx-ii-insertable-cardiac-monitor-system-serve/"}, {"id": "fda-device-z-3066-2026", "source": "FDA", "category": "device", "recall_number": "Z-3066-2026", "title": "Baxter Novum IQ Syringe Pump recall (Baxter Healthcare Corporation)", "product": "Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL", "reason": "A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "4 units", "codes": "UDI-DI 00197886002300, all serial numbers", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3066-2026%22", "url": "https://recallledger.net/recalls/device-z-3066-2026-baxter-novum-iq-syringe-pump-loaner-model-number-40800baxusl/"}, {"id": "fda-device-z-3065-2026", "source": "FDA", "category": "device", "recall_number": "Z-3065-2026", "title": "Baxter Novum IQ Syringe Pump recall (Baxter Healthcare Corporation)", "product": "Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS", "reason": "A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2026-08-11", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MI", "MN", "MO", "MS", "MT", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "14601 units", "codes": "UDI-DI 05413765852428, all serial numbers", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3065-2026%22", "url": "https://recallledger.net/recalls/device-z-3065-2026-baxter-novum-iq-syringe-pump-model-number-40800baxus/"}, {"id": "fda-device-z-3043-2026", "source": "FDA", "category": "device", "recall_number": "Z-3043-2026", "title": "Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231 recall (Philips North America Llc)", "product": "Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x", "reason": "Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-07", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US and US Territories.", "states": [], "nationwide": false, "quantity": "N/A", "codes": "Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3043-2026%22", "url": "https://recallledger.net/recalls/device-z-3043-2026-philips-brilliance-ct-64-brilliance-ct-64-channel-product-code-72823/"}, {"id": "fda-device-z-3042-2026", "source": "FDA", "category": "device", "recall_number": "Z-3042-2026", "title": "Philips Ingenuity CT  Product Codes: Ingenuity CT Upgrades 728327 recall (Philips North America Llc)", "product": "Philips Ingenuity CT  Product Codes: Ingenuity CT Upgrades 728327,   Ingenuity CT China 728324,  Ingenuity Core 128 Elite Brazil 728325.   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Models: Brilliance iCT recall (Philips North America Llc)", "product": "Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x     Product Codes: 728306, 728305, 728311.", "reason": "Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2026-08-07", "report_date": "2026-09-09", "status": "Ongoing", "distribution": "US and US Territories.", "states": [], "nationwide": false, "quantity": "N/A", "codes": "UDI for Brilliance iCT: (01)00884838059474,  UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3040-2026%22", "url": "https://recallledger.net/recalls/device-z-3040-2026-philips-brilliance-models-brilliance-ict-brilliance-ict-upgrades-b/"}, {"id": "fda-food-h-1381-2026", "source": "FDA", "category": "food", "recall_number": "H-1381-2026", "title": "Clear glass bottle with black screw lid with multi label which reads in part as... recall (Africando Foods LLC)", "product": "Clear glass bottle with black screw lid with multi label which reads in part as \"***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garlic, Onions, Water, Distilled 5% White Vinegar, Spices***Manufactured and Packed By Africando Foods, LLC 1121S Gilbert Ct. Iowa City, IA 52240***\"", "reason": "Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list", "hazard_level": "Class II", "company": "Africando Foods LLC", "company_location": "Iowa City, IA, United States", "date": "2026-08-10", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "8 wholesale and retail locations in IA, KY and IL", "states": ["IA", "IL", "KY"], "nationwide": false, "quantity": "720 (8 oz) jars", "codes": "UPC: 860004527114 AF25296, exp. 10/23/2026 AF25303, exp. 10/30/2026 AF25319, exp. 11/15/2026 AF25333, exp. 11/29/2026 AF25343, exp. 12/09/2026 AF25357, exp. 12/23/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1381-2026%22", "url": "https://recallledger.net/recalls/food-h-1381-2026-clear-glass-bottle-with-black-screw-lid-with-multi-label-which-reads-i/"}, {"id": "fda-food-h-1333-2026", "source": "FDA", "category": "food", "recall_number": "H-1333-2026", "title": "Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT recall (Horizon Organic Dairy, LLC)", "product": "Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT (Item 136990, UPC 742365002700) and 18 CT (Item 136917, UPC 742365208867). Tetra Pak Carton. Distributed by: Horizon Organic Dairy, LLC ( Horizon ) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening.", "reason": "Product has the potential to be spoiled.", "hazard_level": "Class II", "company": "Horizon Organic Dairy, LLC", "company_location": "Broomfield, CO, United States", "date": "2026-08-07", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Distributed throughout the United States.", "states": [], "nationwide": true, "quantity": "53,760 cases= (12 CT) 34,524 cases and (18 CT) 19,236 cases", "codes": "ORG ASEP CHOC MILK 1% 8OZ 12 CT: Best By 28 JAN 2027, 30 JAN 2027, 31 JAN 2027, 01 FEB 2027, 02 FEB 2027, and 03 FEB 2027  ORG ASEP CHOC MILK 1% 8OZ 18 CT: Best By 31 JAN 2027, 01 FEB 2027, and 02 FEB 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1333-2026%22", "url": "https://recallledger.net/recalls/food-h-1333-2026-horizon-organic-org-asep-choc-milk-1-8oz-12-ct-item-136990-upc-7423/"}, {"id": "fda-food-h-1332-2026", "source": "FDA", "category": "food", "recall_number": "H-1332-2026", "title": "Mehadrin Chocolate Leben recall (UPSTATE NIAGARA COOPERATIVE)", "product": "Mehadrin Chocolate Leben; 6 OZ (170g) CUPS, UPC: 070784023144", "reason": "Product may have been improperly pasteurized.", "hazard_level": "Class II", "company": "UPSTATE NIAGARA COOPERATIVE", "company_location": "Lancaster, NY, United States", "date": "2026-08-10", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "NJ", "states": ["NJ"], "nationwide": false, "quantity": "3,975 cases", "codes": "Lot code: 101426 L5 2W Use by date: 10/14/26", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1332-2026%22", "url": "https://recallledger.net/recalls/food-h-1332-2026-mehadrin-chocolate-leben-6-oz-170g-cups-upc-070784023144/"}, {"id": "fda-food-h-1301-2026", "source": "FDA", "category": "food", "recall_number": "H-1301-2026", "title": "Jalapeno Ranch recall (Jaime's Foods ATX, LLC)", "product": "Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.", "reason": "Undeclared Egg Allergen", "hazard_level": "Class I", "company": "Jaime's Foods ATX, LLC", "company_location": "Austin, TX, United States", "date": "2026-08-05", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Texas", "states": ["TX"], "nationwide": false, "quantity": "102 cases", "codes": "69, 86, 108, 113, 116, and 121.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1301-2026%22", "url": "https://recallledger.net/recalls/food-h-1301-2026-jalapeno-ranch-packed-in-16-oz-glass-jars-6-jars-per-case-with-upc/"}, {"id": "fda-food-h-1278-2026", "source": "FDA", "category": "food", "recall_number": "H-1278-2026", "title": "Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts recall (Byron White Formulas, Inc.)", "product": "Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts (Juglans nigra hull)  Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404", "reason": "Label does not declare walnuts in English", "hazard_level": "Class II", "company": "Byron White Formulas, Inc.", "company_location": "Santa Rosa, CA, United States", "date": "2026-08-11", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Foreign: Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Japan, Norway, New Zealand, Saudi Arabia.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "10,403 units", "codes": "Lot Code Format = MMD,DYY: 022,224. 061,424. 092,324. 022,125. 071,825. 112,125. 040,826.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1278-2026%22", "url": "https://recallledger.net/recalls/food-h-1278-2026-byron-white-formulas-a-fng-herbal-supplement-1-0-fl-oz-30-ml-may-co/"}, {"id": "fda-food-h-1277-2026", "source": "FDA", "category": "food", "recall_number": "H-1277-2026", "title": "Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts recall (Byron White Formulas, Inc.)", "product": "Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts (Juglans nigra hull)  Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404", "reason": "Label does not declare walnuts in English", "hazard_level": "Class II", "company": "Byron White Formulas, Inc.", "company_location": "Santa Rosa, CA, United States", "date": "2026-08-11", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Foreign: Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Japan, Norway, New Zealand, Saudi Arabia.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "3,486 units", "codes": "Lot Code Format = MMD,DYY: 120,623. 031,824. 070,324. 100,224. 041,425. 101,625.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1277-2026%22", "url": "https://recallledger.net/recalls/food-h-1277-2026-byron-white-formulas-a-p-herbal-supplement-1-0-fl-oz-30-ml-may-cont/"}, {"id": "fda-food-h-1276-2026", "source": "FDA", "category": "food", "recall_number": "H-1276-2026", "title": "Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts recall (Byron White Formulas, Inc.)", "product": "Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL  May Contain Nuts (Juglans nigra hull)  Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404", "reason": "Label does not declare walnuts in English", "hazard_level": "Class II", "company": "Byron White Formulas, Inc.", "company_location": "Santa Rosa, CA, United States", "date": "2026-08-11", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Foreign: Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Japan, Norway, New Zealand, Saudi Arabia.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "CT", "DC", "DE", "FL", "GA", "HI", "IA", "ID", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MT", "NC", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "18,791 units", "codes": "Lot Code Format = MMD,DYY: 012,324. 041,924. 062,824. 092,024. 101,624. 111,324. 071,425. 093,025. 012,026. 042,826.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1276-2026%22", "url": "https://recallledger.net/recalls/food-h-1276-2026-byron-white-formulas-a-l-complex-herbal-supplement-1-0-fl-oz-30-ml/"}, {"id": "fda-food-h-1271-2026", "source": "FDA", "category": "food", "recall_number": "H-1271-2026", "title": "Marketside Tomato Bisque Soup Kit recall (CUISINE, KETTLE)", "product": "Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.", "reason": "Product had a presumptive positive test result for Listeria monocytogenes", "hazard_level": "Class II", "company": "CUISINE, KETTLE", "company_location": "Savage, MD, United States", "date": "2026-08-11", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The recalled product was distributed to the following States: IL, NV, NM, CA, OK, TX, PA, OH, NC, NY, GA, and AR.", "states": ["AR", "CA", "GA", "IL", "NC", "NM", "NV", "NY", "OH", "OK", "PA", "TX"], "nationwide": false, "quantity": "540 cases", "codes": "Best By/ Use By: 8/22/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1271-2026%22", "url": "https://recallledger.net/recalls/food-h-1271-2026-marketside-tomato-bisque-soup-kit-tomato-bisque-with-cheese-croutons/"}, {"id": "fda-food-h-1269-2026", "source": "FDA", "category": "food", "recall_number": "H-1269-2026", "title": "Outshine Fruit Bars Strawberry recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce,  UPC 041548816678, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "94 pallets", "codes": "Batch code/ Best Before (bottom of package: LLA603840   31 MAY 2027 LLA605540   31 MAY 2027 LLA605640   31 MAY 2027 LLA605740   31 MAY 2027 LLA605940   31 MAY 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1269-2026%22", "url": "https://recallledger.net/recalls/food-h-1269-2026-outshine-fruit-bars-strawberry-pineapple-grape-tangerine-24-count/"}, {"id": "fda-food-h-1268-2026", "source": "FDA", "category": "food", "recall_number": "H-1268-2026", "title": "Outshine Fruit Bars Black Cherry recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "226 pallets", "codes": "Batch code/ Best Before (bottom of package):  LLA618503   31 JUL 2027 LLA618603   31 JUL 2027 LLA618703   31 JUL 2027 LLA618803   31 JUL 2027 LLA618903   31 JUL 2027 LLA619003   31 JUL 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1268-2026%22", "url": "https://recallledger.net/recalls/food-h-1268-2026-outshine-fruit-bars-black-cherry-6-bars-2-5-ounce-with-upc-04154800/"}, {"id": "fda-food-h-1267-2026", "source": "FDA", "category": "food", "recall_number": "H-1267-2026", "title": "Outshine Fruit Bars Tangerine recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "44 pallets", "codes": "Batch code/ Best Before (bottom of package):  LLA619603   31 OCT 2027 LLA619703   31 OCT 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1267-2026%22", "url": "https://recallledger.net/recalls/food-h-1267-2026-outshine-fruit-bars-tangerine-6-count-2-5-ounce-with-upc-04154861204/"}, {"id": "fda-food-h-1266-2026", "source": "FDA", "category": "food", "recall_number": "H-1266-2026", "title": "Outshine Fruit Bars Grape recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "281 pallets", "codes": "Batch code/ Best Before (bottom of package): LLA616803   30 SEP 2027 LLA616903   30 SEP 2027 LLA619703   31 OCT 2027  UPC Bottom of package: 041548244044  LLA619803   31 OCT 2027 LLA619903   31 OCT 2027 LLA620003   31 OCT 2027 LLA620103   31 OCT 2027 LLA620203   31 OCT 2027 LLA620303   31 OCT 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1266-2026%22", "url": "https://recallledger.net/recalls/food-h-1266-2026-outshine-fruit-bars-grape-6-count-2-5-ounce-with-upc-041548244044-p/"}, {"id": "fda-food-h-1265-2026", "source": "FDA", "category": "food", "recall_number": "H-1265-2026", "title": "Outshine Fruit Bar Watermelon recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "685 pallets", "codes": "Batch code/ Best Before (bottom of package): LLA617603   30 JUN 2027 LLA617703   30 JUN 2027 LLA617803   30 JUN 2027 LLA617903   30 JUN 2027 LLA618003   30 JUN 2027 LLA618103   30 JUN 2027 LLA618203   31 JUL 2027 LLA618303   31 JUL 2027 LLA618403   31 JUL 2027 LLA618503   31 JUL 2027 LLA619003   31 JUL 2027 LLA619103   31 JUL 2027 LLA619203   31 JUL 2027 LLA619303   31 JUL 2027 LLA619403   31 JUL 2027 LLA619503   31 JUL 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1265-2026%22", "url": "https://recallledger.net/recalls/food-h-1265-2026-outshine-fruit-bar-watermelon-6-count-2-5-ounce-with-upc-041548413624/"}, {"id": "fda-food-h-1264-2026", "source": "FDA", "category": "food", "recall_number": "H-1264-2026", "title": "Outshine Fruit Bars Strawberry recall (Dreyer's Grand  Ice Cream Inc.)", "product": "Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper.  Keep at 0F (-18C) or colder.", "reason": "Foreign object: products may contain glass pieces", "hazard_level": "Class II", "company": "Dreyer's Grand  Ice Cream Inc.", "company_location": "Laurel, MD, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "The adulterated product was distributed to the following States: AL, AR, AZ, CA,CO,CT, FL,GA, IA,ID, IL, KS, LA, MA,MD,MI, MN,MO, NC, ND, NH, NJ, NV, NY, OH, PA, PR, TN TX, UT, VA, VI, WA, and WI.", "states": ["AL", "AR", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "ID", "IL", "KS", "LA", "MA", "MD", "MI", "MN", "MO", "NC", "ND", "NH", "NJ", "NV", "NY", "OH", "PA", "PR", "TN", "TX", "UT", "VA", "WA", "WI"], "nationwide": false, "quantity": "644 pallets", "codes": "Batch code/ Best Before (bottom of package): LLA616903   30 SEP 2027 LLA617003   30 SEP 2027 LLA617103   30 SEP 2027 LLA617203   30 SEP 2027 LLA617303   30 SEP 2027 LLA617403   30 SEP 2027 LLA617503   30 SEP 2027 LLA617603   30 SEP 2027 LLA620303   31 OCT 2027 LLA620403   31 OCT 2027 LLA620503   31 OCT 2027 LLA620603   31 OCT 2027 LLA620703   31 OCT 2027 LLA620803   31 OCT 2027 LLA620903   31 OCT 2027 LLA621003   31 OCT 2027 LLA621103   31 OCT 2027 LLA621203   31 OCT 2027 LLA621303   30 NOV 2027 LLA621403   30 NOV 2027 LLA621503   30 NOV 2027 LLA621603   30 NOV 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1264-2026%22", "url": "https://recallledger.net/recalls/food-h-1264-2026-outshine-fruit-bars-strawberry-6-count-2-5-ounce-with-upc-0415486100/"}, {"id": "fda-food-h-1262-2026", "source": "FDA", "category": "food", "recall_number": "H-1262-2026", "title": "Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB recall (Sirna and Sons Produce, Inc)", "product": "Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB, repackaged into 1 lb. plastic bags, Product Number: 55255, Packed by Sirna & Sons Produce 7176 State Route 88, Ravenna, OH 44266, distributed for food service use only", "reason": "Potential Salmonella Javiana contamination", "hazard_level": "Class I", "company": "Sirna and Sons Produce, Inc", "company_location": "Ravenna, OH, United States", "date": "2026-08-05", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "OH, PA (for food service use only)", "states": ["OH", "PA"], "nationwide": false, "quantity": "249 bags", "codes": "Lot Numbers: 60947409, 60991812 Pack Dates: 07/13/26, 07/23/26 Internal Product Number: 00184", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1262-2026%22", "url": "https://recallledger.net/recalls/food-h-1262-2026-sirna-sons-produce-pepper-jalapeno-break-1lb-repackaged-into-1-lb/"}, {"id": "fda-food-h-1258-2026", "source": "FDA", "category": "food", "recall_number": "H-1258-2026", "title": "Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package... recall (H & U Inc. dba Sun Noodle)", "product": "Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet.   Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105  Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI", "reason": "Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.", "hazard_level": "Class I", "company": "H & U Inc. dba Sun Noodle", "company_location": "Honolulu, HI, United States", "date": "2026-08-04", "report_date": "2026-09-02", "status": "Terminated", "distribution": "Distribute in HI.", "states": [], "nationwide": false, "quantity": "140 packages", "codes": "Production Lot: 1226183  Products will be dated for expiration according to their date of defrost by retailer or distributor in the following format: MM/DD", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1258-2026%22", "url": "https://recallledger.net/recalls/food-h-1258-2026-sura-tanmen-hot-and-sour-flavor-premium-japanese-noodles-soup-base/"}, {"id": "fda-drug-d-0832-2026", "source": "FDA", "category": "drug", "recall_number": "D-0832-2026", "title": "Lactated Ringer's Injection USP recall (B BRAUN MEDICAL INC)", "product": "Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00", "reason": "Presence of Particulate matter.", "hazard_level": "Class I", "company": "B BRAUN MEDICAL INC", "company_location": "Allentown, PA, United States", "date": "2026-08-12", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "U.S. Nationwide", "states": [], "nationwide": true, "quantity": "23,688 bags", "codes": "Lot#: J4H077, Exp 30NOV2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0832-2026%22", "url": "https://recallledger.net/recalls/drug-d-0832-2026-lactated-ringer-s-injection-usp-1000-ml-excel-container-rx-only-l75/"}, {"id": "fda-drug-d-0831-2026", "source": "FDA", "category": "drug", "recall_number": "D-0831-2026", "title": "Ramipril Capsules USP recall (Hikma Pharmaceuticals USA INC.)", "product": "Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH  43228.", "reason": "Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).", "hazard_level": "Class II", "company": "Hikma Pharmaceuticals USA INC.", "company_location": "Columbus, OH, United States", "date": "2026-08-24", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "a) 25,970 bottles; b) 2,384 bottles", "codes": "a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0831-2026%22", "url": "https://recallledger.net/recalls/drug-d-0831-2026-ramipril-capsules-usp-10-mg-packaged-in-a-100-capsules-ndc-76282-6/"}, {"id": "fda-drug-d-0827-2026", "source": "FDA", "category": "drug", "recall_number": "D-0827-2026", "title": "Tyenne recall (Fresenius Kabi USA, LLC)", "product": "Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured  by Fresenius Kabi USA, LLC,  Lake Zurich, Illinois, 60047, NDC 65219-594-20.", "reason": "Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.", "hazard_level": "Class I", "company": "Fresenius Kabi USA, LLC", "company_location": "Lake Zurich, IL, United States", "date": "2026-08-10", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "4,643 20mL-vials", "codes": "Lot: 16UI07, Exp 08/31/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0827-2026%22", "url": "https://recallledger.net/recalls/drug-d-0827-2026-tyenne-tocilizumab-aazg-injection-400-mg-20-ml-20-mg-ml-20-ml-vi/"}, {"id": "fda-drug-d-0804-2026", "source": "FDA", "category": "drug", "recall_number": "D-0804-2026", "title": "Paxil CR recall (Apotex Corp.)", "product": "Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3", "reason": "Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria", "hazard_level": "Class II", "company": "Apotex Corp.", "company_location": "Weston, FL, United States", "date": "2026-08-13", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "6,972 bottles", "codes": "Lot # TY9494, Exp Date: 05/31/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2026%22", "url": "https://recallledger.net/recalls/drug-d-0804-2026-paxil-cr-paroxetine-extended-release-tablets-37-5mg-30-count-bottl/"}, {"id": "fda-drug-d-0803-2026", "source": "FDA", "category": "drug", "recall_number": "D-0803-2026", "title": "Acthar Gel recall (Mallinckrodt Hospital Products Inc.)", "product": "Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2", "reason": "Presence of particulate matter: glass and stopper piece", "hazard_level": "Class II", "company": "Mallinckrodt Hospital Products Inc.", "company_location": "Bridgewater, NJ, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "12367 vials", "codes": "Lot#:  NDC 63004-8710-1 - 1564-107, exp 1/31/2027  NDC 63004-8710-2 - 1564-107H, exp 1/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2026%22", "url": "https://recallledger.net/recalls/drug-d-0803-2026-acthar-gel-repository-corticotropin-injection-5-ml-multiple-dose-vi/"}, {"id": "fda-drug-d-0790-2026", "source": "FDA", "category": "drug", "recall_number": "D-0790-2026", "title": "Zicam recall (Church & Dwight Co., Inc.)", "product": "Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.", "reason": "CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing", "hazard_level": "Class II", "company": "Church & Dwight Co., Inc.", "company_location": "Ewing, NJ, United States", "date": "2026-08-10", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "318,600 cartons", "codes": "Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0790-2026%22", "url": "https://recallledger.net/recalls/drug-d-0790-2026-zicam-cold-remedy-medicated-nasal-swabs-with-cooling-menthol-euca/"}, {"id": "fda-drug-d-0789-2026", "source": "FDA", "category": "drug", "recall_number": "D-0789-2026", "title": "Clobetasol Propionate Cream USP recall (Lupin Pharmaceuticals Inc.)", "product": "Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.", "reason": "Failed content uniformity specifications.", "hazard_level": "Class II", "company": "Lupin Pharmaceuticals Inc.", "company_location": "Naples, FL, United States", "date": "2026-08-03", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "5082 tubes", "codes": "Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2026%22", "url": "https://recallledger.net/recalls/drug-d-0789-2026-clobetasol-propionate-cream-usp-0-05-60-g-tube-rx-only-manufactur/"}, {"id": "fda-drug-d-0786-2026", "source": "FDA", "category": "drug", "recall_number": "D-0786-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2402337, Exp. Date 10/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0786-2026%22", "url": "https://recallledger.net/recalls/drug-d-0786-2026-levothyroxine-sodium-tablets-usp-300-mcg-0-3-mg-90-count-bottles/"}, {"id": "fda-drug-d-0785-2026", "source": "FDA", "category": "drug", "recall_number": "D-0785-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC  16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0785-2026%22", "url": "https://recallledger.net/recalls/drug-d-0785-2026-levothyroxine-sodium-tablets-usp-200-mcg-0-2-mg-packaged-in-a-90/"}, {"id": "fda-drug-d-0784-2026", "source": "FDA", "category": "drug", "recall_number": "D-0784-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "a) Lot #: D2402642, Exp. Date 11/30/2026 b) Lot #: D2401832, Exp. Date 08/31/2026; D2402525, D2402527, D2402526, D2402644, D2402643, Exp. Date 11/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0784-2026%22", "url": "https://recallledger.net/recalls/drug-d-0784-2026-levothyroxine-sodium-tablets-usp-175-mcg-0-175-mg-packaged-in-a/"}, {"id": "fda-drug-d-0783-2026", "source": "FDA", "category": "drug", "recall_number": "D-0783-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0783-2026%22", "url": "https://recallledger.net/recalls/drug-d-0783-2026-levothyroxine-sodium-tablets-usp-150-mcg-0-15-mg-1000-count-bottl/"}, {"id": "fda-drug-d-0782-2026", "source": "FDA", "category": "drug", "recall_number": "D-0782-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0782-2026%22", "url": "https://recallledger.net/recalls/drug-d-0782-2026-levothyroxine-sodium-tablets-usp-137-mcg-0-137-mg-packaged-in-a/"}, {"id": "fda-drug-d-0781-2026", "source": "FDA", "category": "drug", "recall_number": "D-0781-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0781-2026%22", "url": "https://recallledger.net/recalls/drug-d-0781-2026-levothyroxine-sodium-tablets-usp-125-mcg-0-125-mg-1000-count-bott/"}, {"id": "fda-drug-d-0780-2026", "source": "FDA", "category": "drug", "recall_number": "D-0780-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2402443, D2402444, D2402445, Exp. Date 10/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0780-2026%22", "url": "https://recallledger.net/recalls/drug-d-0780-2026-levothyroxine-sodium-tablets-usp-112-mcg-0-112-mg-1000-count-bott/"}, {"id": "fda-drug-d-0779-2026", "source": "FDA", "category": "drug", "recall_number": "D-0779-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "a) Lot #: D2402186, Exp. Date 09/30/2026. b) Lot #: D2402019, Exp. Date 08/31/2026; D2402094, Exp. Date 09/30/2026; D2500022, D2500023, D2500021, Exp. Date 12/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0779-2026%22", "url": "https://recallledger.net/recalls/drug-d-0779-2026-levothyroxine-sodium-tablets-usp-100-mcg-0-1-mg-packaged-in-a-90/"}, {"id": "fda-drug-d-0778-2026", "source": "FDA", "category": "drug", "recall_number": "D-0778-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2401813, D2401814, Exp. Date 08/31/2026; D2500200, D2500219, Exp. Date 12/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0778-2026%22", "url": "https://recallledger.net/recalls/drug-d-0778-2026-levothyroxine-sodium-tablets-usp-88-mcg-0-088-mg-1000-count-bottl/"}, {"id": "fda-drug-d-0777-2026", "source": "FDA", "category": "drug", "recall_number": "D-0777-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2402016, D2402017, Exp. Date 08/31/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0777-2026%22", "url": "https://recallledger.net/recalls/drug-d-0777-2026-levothyroxine-sodium-tablets-usp-75-mcg-0-075-mg-1000-count-bottl/"}, {"id": "fda-drug-d-0776-2026", "source": "FDA", "category": "drug", "recall_number": "D-0776-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0776-2026%22", "url": "https://recallledger.net/recalls/drug-d-0776-2026-levothyroxine-sodium-tablets-usp-50-mcg-0-05-mg-1000-count-bottle/"}, {"id": "fda-drug-d-0775-2026", "source": "FDA", "category": "drug", "recall_number": "D-0775-2026", "title": "Levothyroxine Sodium Tablets recall (ACCORD HEALTHCARE, INC.)", "product": "Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.", "reason": "Subpotent Drug", "hazard_level": "Class II", "company": "ACCORD HEALTHCARE, INC.", "company_location": "Raleigh, NC, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026;  D2500223, Exp. Date 01/31/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0775-2026%22", "url": "https://recallledger.net/recalls/drug-d-0775-2026-levothyroxine-sodium-tablets-usp-25-mcg-0-025-mg-1000-count-bottl/"}, {"id": "fda-device-z-3035-2026", "source": "FDA", "category": "device", "recall_number": "Z-3035-2026", "title": "POWERSEAL 5 MM recall (Olympus Corporation of the Americas)", "product": "POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.    GEI / Electrosurgical, cutting & coagulation & accessories", "reason": "Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.", "hazard_level": "Class II", "company": "Olympus Corporation of the Americas", "company_location": "Center Valley, PA, United States", "date": "2026-08-18", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.", "states": ["FL", "KS"], "nationwide": true, "quantity": "335 units", "codes": "Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3035-2026%22", "url": "https://recallledger.net/recalls/device-z-3035-2026-powerseal-5-mm-in-diameter-23-cm-long-curved-jaw-sealer-divider/"}, {"id": "fda-device-z-3034-2026", "source": "FDA", "category": "device", "recall_number": "Z-3034-2026", "title": "ORT300 recall (IMRIS Imaging Inc)", "product": "ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600", "reason": "The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.", "hazard_level": "Class II", "company": "IMRIS Imaging Inc", "company_location": "Chaska, MN, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.", "states": [], "nationwide": true, "quantity": "13 units", "codes": "114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119;  114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3034-2026%22", "url": "https://recallledger.net/recalls/device-z-3034-2026-ort300-operating-room-table-ort300-modular-table-main-unit-assy-part/"}, {"id": "fda-device-z-3033-2026", "source": "FDA", "category": "device", "recall_number": "Z-3033-2026", "title": "ORT200 recall (IMRIS Imaging Inc)", "product": "ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000", "reason": "The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.", "hazard_level": "Class II", "company": "IMRIS Imaging Inc", "company_location": "Chaska, MN, United States", "date": "2026-08-06", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.", "states": [], "nationwide": true, "quantity": "6 units", "codes": "113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3033-2026%22", "url": "https://recallledger.net/recalls/device-z-3033-2026-ort200-operating-room-table-including-the-ort200-covered-table-assem/"}, {"id": "fda-device-z-3014-2026", "source": "FDA", "category": "device", "recall_number": "Z-3014-2026", "title": "Alphenix Models  INFX-8000C  INFX-8000F  INFX-8000V    This device is a digital... recall (Canon Medical System, USA, INC.)", "product": "Alphenix Models  INFX-8000C  INFX-8000F  INFX-8000V    This device is a digital radiography/fluoroscopy system used in a diagnostic and  interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.", "reason": "Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2026-08-04", "report_date": "2026-09-02", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and TX.", "states": ["CA", "GA", "MN", "NC", "NV", "OH", "PA", "TX"], "nationwide": true, "quantity": "10 systems", "codes": "Model Number: INFX-8000C/B3 UDI code: Pending SID Number:30101165   Serial Number: B3E2422005   Model Number: INFX-8000F/SG UDI code: Pending SID Number: 30093711 Serial Number: SGC2412001  Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30029686 Serial Number: SZA2422001 SID Number: 79000002 Serial Number:SZA2442004    Model Number: INFX-8000V/SX UDI code: Pending SID Number: 30049491 Serial Number: SXA2432001 SID Number: 30100053 Serial Number: SXA2432002  Model Number: INFX-8000V/B9 UDI code: Pending SID Number: 30059175 Serial Number: B9F2412001  Model Number: INFX-8000V/ST UDI code: Pending SID Number: 30059180 Serial Number: STA2412001  Model Number: INFX-8000V/SZ UDI code: Pending SID Number: 30095017 Serial Number: SZA2432003 SID Number: 30097052 Serial Number: SZA2422002", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3014-2026%22", "url": "https://recallledger.net/recalls/device-z-3014-2026-alphenix-models-infx-8000c-infx-8000f-infx-8000v-this-device-is/"}, {"id": "cpsc-26727", "source": "CPSC", "category": "consumer-product", "recall_number": "26727", "title": "Montessori Baby Toy Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Chillife Official", "product": "Chillife 5-in-1 Montessori Baby Toy Sets", "reason": "The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can reach the back of children’s throat and become lodged, posing a risk of respiratory distress and deadly choking hazard.", "hazard_level": null, "company": "Shenzhenshixingchuangyiyimaoyouxiangongsi (Shenzhen Xingchuangyi Trading Co., Ltd.) dba Chillife Official, China.", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nAmazon.com from July 2023 through April 2026 for about $27.", "states": [], "nationwide": true, "quantity": "About 20,134", "codes": "", "remedy": "Consumers should stop using the pull string teether toys immediately, take them away from children and contact Chillife Official for a partial refund of $5.40. Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker “DESTROYED” on the main body of the toy and send a photo of the destroyed toy to Chillifebabytoyrecall@outlook.com. Consumers should then dispose of the destroyed product. Refund", "retailers": ["Sold Online At:\nAmazon.com from July 2023 through April 2026 for about $27."], "injuries": "CPSC is aware of four choking incidents.  No medical attention was required.", "source_url": "https://cpsc.gov/Recalls/2026/Montessori-Baby-Toy-Sets-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Choking-Violate-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-Chillife-Official", "url": "https://recallledger.net/recalls/product-26727-montessori-baby-toy-sets-recalled-due-to-risk-of-serious-injury-or-dea/"}, {"id": "cpsc-26726", "source": "CPSC", "category": "consumer-product", "recall_number": "26726", "title": "Walmart Reannounces Recall of Mainstays Nine-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Walmart Distributed Recalled Dressers Post-Recall; Sold to Consumers Through Liquidators", "product": "Mainstays 9-Drawer Fabric Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.", "hazard_level": null, "company": "Hop Thang Interior Wood Co. Ltd., of Vietnam", "company_location": "Vietnam", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold At:\nWalmart stores nationwide and online at Walmart.com from September 2023 through March 2026 for about $80. Recalled dressers were sold to consumers post-recall through the following liquidators: OMG California Community, of Riverside, California; Threads of Fenton of Fenton, Michigan, Golden Cone Electronic, Inc., of Elkhart, Indiana; and ReturnPro, of Miami, Florida. This reannouncement is intended to alert consumers who purchased the dressers from the above liquidators that the dressers have been recalled because they pose tip-over and entrapment hazards.", "states": [], "nationwide": true, "quantity": "About 165,250 (About 165,000 of these dressers were previously recalled in May 2026)", "codes": "", "remedy": "Consumers should stop using the recalled dressers if they are not anchored to the wall immediately, place them in an area that children cannot access and contact Walmart for a full refund. Consumers will be asked to return the dressers’ drawers to any Walmart store and dispose of the dressers’ frame according to local and state regulations. Refund", "retailers": ["Sold At:\nWalmart stores nationwide and online at Walmart.com from September 2023 through March 2026 for about $80. Recalled dressers were sold to consumers post-recall through the following liquidators: OMG California Community, of Riverside, California; Threads of Fenton of Fenton, Michigan, Golden Cone Electronic, Inc., of Elkhart, Indiana; and ReturnPro, of Miami, Florida. This reannouncement is intended to alert consumers who purchased the dressers from the above liquidators that the dressers have been recalled because they pose tip-over and entrapment hazards."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Walmart-Reannounces-Recall-of-Mainstays-Nine-Drawer-Fabric-Dressers-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Walmart-Distributed-Recalled-Dressers-Post-Recall-Sold-to-Consumers-Through-Liquidators", "url": "https://recallledger.net/recalls/product-26726-walmart-reannounces-recall-of-mainstays-nine-drawer-fabric-dressers-du/"}, {"id": "cpsc-26725", "source": "CPSC", "category": "consumer-product", "recall_number": "26725", "title": "Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Sold on Amazon by YERYORK", "product": "YERYORK Pressure Washers", "reason": "The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.", "hazard_level": null, "company": "Lanzhou Xinshi Mingchen Information Technology Co., Ltd., dba YERYORK, of China", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nAmazon.com from March 2025 through June 2026 for about $120.", "states": [], "nationwide": true, "quantity": "300", "codes": "", "remedy": "Consumers should stop using the recalled pressure washers immediately and contact YERYORK for a full refund. Consumers will be asked to unplug the pressure washer, destroy it by cutting the power cord in half, and send a photo of the destroyed power washer, showing the model number, to yeryorkrecalls@outlook.com. Consumers should then dispose of the destroyed recalled product. Refund", "retailers": ["Sold Online At:\nAmazon.com from March 2025 through June 2026 for about $120."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Pressure-Washers-Recalled-Due-to-Serious-Risk-of-Injury-or-Death-from-Shock-and-Electrocution-Hazards-Sold-on-Amazon-by-YERYORK", "url": "https://recallledger.net/recalls/product-26725-pressure-washers-recalled-due-to-serious-risk-of-injury-or-death-from/"}, {"id": "cpsc-26724", "source": "CPSC", "category": "consumer-product", "recall_number": "26724", "title": "Little Loves & Co. Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury or Death from Entrapment Hazard", "product": "Little Loves & Co. Youth Clothing with Drawstrings", "reason": "The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazard.", "hazard_level": null, "company": "Little Loves & Co. LLC, of Olympia, Washington", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nLittlelovesandco.com and Whatnot.com from May 2025 through July 2026 for between $15 and $30.", "states": [], "nationwide": true, "quantity": "About 590", "codes": "", "remedy": "Consumers should take the recalled clothing away from children immediately and contact Little Loves & Co. for a full refund after return of the product. Consumers should contact Little Loves & Co. to receive a pre-paid shipping label to return the garment. Upon receipt, affected consumers will be issued a refund. If consumers would prefer to keep the garment, they should cut and remove the drawstring. Refund Repair", "retailers": ["Sold Online At:\nLittlelovesandco.com and Whatnot.com from May 2025 through July 2026 for between $15 and $30."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Little-Loves-Co-Recalls-Youth-Clothing-with-Drawstrings-Due-to-Risk-of-Serious-Injury-or-Death-from-Entrapment-Hazard", "url": "https://recallledger.net/recalls/product-26724-little-loves-co-recalls-youth-clothing-with-drawstrings-due-to-risk/"}, {"id": "cpsc-26723", "source": "CPSC", "category": "consumer-product", "recall_number": "26723", "title": "Steelite Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and Electrocution Hazards; Sold on Amazon by Longer 3D", "product": "Steelite Electric Pressure Washers", "reason": "The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of serious injury or death from shock and electrocution hazards.", "hazard_level": null, "company": "Longer Technology (Hong Kong) Limited, dba Longer 3D, of China", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nAmazon.com from April 2026 through June 2026 for between $45 and $92.", "states": [], "nationwide": true, "quantity": "About 128", "codes": "", "remedy": "Consumers should stop using the recalled pressure washers immediately and contact Longer 3D for a full refund. Consumers will be asked to destroy the power washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to 2991426091@qq.com. Consumers should then dispose of the destroyed recalled product. Refund", "retailers": ["Sold Online At:\nAmazon.com from April 2026 through June 2026 for between $45 and $92."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Steelite-Pressure-Washers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Shock-and-Electrocution-Hazards-Sold-on-Amazon-by-Longer-3D", "url": "https://recallledger.net/recalls/product-26723-steelite-pressure-washers-recalled-due-to-risk-of-serious-injury-or-de/"}, {"id": "cpsc-26722", "source": "CPSC", "category": "consumer-product", "recall_number": "26722", "title": "Excel Industries Recalls Accessory LED Light Kits Due to Risk of Serious Injury from Fire Hazard", "product": "Accessory LED Light Kits used with certain ride-on mowers", "reason": "The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard.", "hazard_level": null, "company": "Excel Industries LLC, of Hesston, Kansas", "company_location": "United States", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold At:\nHustler and BigDog dealerships nationwide or online at www.hustlerturf.com/law-mower-accessories or www.bigdogmower.com/accessories from April 2020 through July 2026 for between $180 and $330.", "states": [], "nationwide": true, "quantity": "About 1,800", "codes": "", "remedy": "Consumers should stop using the accessory LED Light Kits immediately and contact their point-of-sale dealers to receive a refund upon return of the light kit. Light kits installed on mowers can be removed either at the local dealer or at the consumer’s residence. Refund", "retailers": ["Sold At:\nHustler and BigDog dealerships nationwide or online at www.hustlerturf.com/law-mower-accessories or www.bigdogmower.com/accessories from April 2020 through July 2026 for between $180 and $330."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Excel-Industries-Recalls-Accessory-LED-Light-Kits-Due-to-Risk-of-Serious-Injury-from-Fire-Hazard", "url": "https://recallledger.net/recalls/product-26722-excel-industries-recalls-accessory-led-light-kits-due-to-risk-of-serio/"}, {"id": "cpsc-26721", "source": "CPSC", "category": "consumer-product", "recall_number": "26721", "title": "Kmaier Recalls Infant Walkers Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers", "product": "Kmaier Infant Walkers", "reason": "The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard.", "hazard_level": null, "company": "FENUN, Inc., dba Kmaier, of Pasadena, California", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nTarget.com in June 2026 for between $62 and $70.", "states": [], "nationwide": true, "quantity": "About 243", "codes": "", "remedy": "Consumers should stop using the recalled walkers immediately and contact Kmaier for a full refund. Consumers will be asked to disassemble the walker; destroy it by cutting the walker’s fabric seat and writing in permanent marker “Recalled” on the top of the tray; and send a photo of the destroyed walker to TargetplusSJ@outlook.com. Consumers should then dispose of the recalled product. Refund", "retailers": ["Sold Online At:\nTarget.com in June 2026 for between $62 and $70."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Kmaier-Recalls-Infant-Walkers-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-Hazard-Violate-Mandatory-Standard-for-Infant-Walkers", "url": "https://recallledger.net/recalls/product-26721-kmaier-recalls-infant-walkers-due-to-risk-of-serious-injury-or-death-f/"}, {"id": "cpsc-26720", "source": "CPSC", "category": "consumer-product", "recall_number": "26720", "title": "AudioLineOut Recalls Studio Six Headphone Amplifiers Due to Risk of Serious Injury or Death from Electrocution Hazard", "product": "Studio Six Headphone Amplifiers", "reason": "When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or death from electrocution.", "hazard_level": null, "company": "AudioLineOut LLC, of Portland, Oregon", "company_location": "United States", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold At:\nIndependent stereo stores nationwide and online at aloaudio.com from December 2014 through December 2022 for about $3,900.", "states": [], "nationwide": true, "quantity": "About 90", "codes": "", "remedy": "Consumers should stop using the recalled amplifiers immediately and contact AudioLineOut for a free repair. Consumers should contact AudioLineOut at support@aloaudio.com for a prepaid shipping label to ship back the product for repair. Alternatively, consumers can utilize the originally supplied vacuum tubes. Repair", "retailers": ["Sold At:\nIndependent stereo stores nationwide and online at aloaudio.com from December 2014 through December 2022 for about $3,900."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/AudioLineOut-Recalls-Studio-Six-Headphone-Amplifiers-Due-to-Risk-of-Serious-Injury-or-Death-from-Electrocution-Hazard", "url": "https://recallledger.net/recalls/product-26720-audiolineout-recalls-studio-six-headphone-amplifiers-due-to-risk-of-se/"}, {"id": "cpsc-26719", "source": "CPSC", "category": "consumer-product", "recall_number": "26719", "title": "HABA USA Recalls Rainbow Rattle Grasping and Teething Toys Due to Risk of Serious Injury or Death from Choking and Ingestion Hazards", "product": "HABA Rainbow Rattle Grasping and Teething Toy", "reason": "The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plastic pieces, posing a risk of serious injury or death from choking and ingestion hazards.", "hazard_level": null, "company": "Habermaass Corporation, Inc. dba HABA USA, of Skaneateles, New York", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold At:\nSpecialty stores nationwide and online at Amazon.com, Target.com, Bellalunatoys.com, Habausa.com and Nordstrom.com from December 2025 through July 2026 for about $13.", "states": [], "nationwide": true, "quantity": "About 2,000", "codes": "", "remedy": "Consumers should stop using the rattle grasping and teething toy immediately, take it away from children and contact HABA USA to receive a full refund. Consumers will be asked to destroy the toy by cutting the elastic cord, taking a photo of it and uploading a photo of the destroyed toy with their name and address to recall@habausa.com. Consumers should then dispose of the destroyed product. Refund", "retailers": ["Sold At:\nSpecialty stores nationwide and online at Amazon.com, Target.com, Bellalunatoys.com, Habausa.com and Nordstrom.com from December 2025 through July 2026 for about $13."], "injuries": "The firm has received two reports of the knots on the elastic cord becoming untied. No injuries have been reported.", "source_url": "https://cpsc.gov/Recalls/2026/HABA-USA-Recalls-Rainbow-Rattle-Grasping-and-Teething-Toys-Due-to-Risk-of-Serious-Injury-or-Death-from-Choking-and-Ingestion-Hazards", "url": "https://recallledger.net/recalls/product-26719-haba-usa-recalls-rainbow-rattle-grasping-and-teething-toys-due-to-risk/"}, {"id": "cpsc-26718", "source": "CPSC", "category": "consumer-product", "recall_number": "26718", "title": "Diamond Wipes International Recalls MD Wipe Outz Numbing Tattoo Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging", "product": "MD Wipe Outz Numbing Tattoo Wipes", "reason": "The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.", "hazard_level": null, "company": "Diamond Wipes International, Inc., of Chino, California", "company_location": "United States", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold Online At:\nAmazon.com from September 2025 through June 2026 and Shopify.com from September 2025 through May 2026 for between about $7.50 for a 5-pack and $225 for a 250-pack.", "states": [], "nationwide": true, "quantity": "About 55,250", "codes": "", "remedy": "Consumers should secure the wipes out of sight and reach of children immediately and contact Diamond Wipes for a full refund. Consumers will be asked to write “RECALLED” on the packet and send a photo of the marked packet to recall@diamondwipes.com. Consumers should then dispose of the packets. Refund", "retailers": ["Sold Online At:\nAmazon.com from September 2025 through June 2026 and Shopify.com from September 2025 through May 2026 for between about $7.50 for a 5-pack and $225 for a 250-pack."], "injuries": "None reported", "source_url": "https://cpsc.gov/Recalls/2026/Diamond-Wipes-International-Recalls-MD-Wipe-Outz-Numbing-Tattoo-Wipes-Due-to-Risk-of-Serious-Injury-or-Death-from-Child-Poisoning-Violate-Mandatory-Standard-for-Child-Resistant-Packaging?utm_campaign=&utm_content=&utm_medium=email&utm_source=govdelivery&utm_term=20260827", "url": "https://recallledger.net/recalls/product-26718-diamond-wipes-international-recalls-md-wipe-outz-numbing-tattoo-wipes/"}, {"id": "cpsc-26717", "source": "CPSC", "category": "consumer-product", "recall_number": "26717", "title": "Conair Expands Recall of Cuisinart Grill Brushes Due to Ingestion Hazard; Over 3.6 Million Brushes Now Recalled", "product": "Metal Wire Bristle Grill Brushes", "reason": "Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.", "hazard_level": null, "company": "Conair LLC of Stamford, Connecticut", "company_location": "China", "date": "2026-08-27", "report_date": "2026-08-27", "status": "Announced", "distribution": "Sold in the United States at Sold At:\nWalmart, Burlington, TJ Maxx and Ross and online including Amazon and Cuisinart.com from June 2009 through March 2026 for between $8 and $20.", "states": [], "nationwide": true, "quantity": "About 1,905,805 additional brushes (Conair previously recalled 1,719,995 grill brushes in July 2026 for a total of 3,625,800)", "codes": "", "remedy": "Consumers should stop using the recalled grill brushes immediately and contact Conair for a full refund or a credit for use at Cuisinart.com for a full refund plus 20% of the cash refund amount. Consumers will be asked to discard the recalled grill brushes. Refund", "retailers": ["Sold At:\nWalmart, Burlington, TJ Maxx and Ross and online including Amazon and Cuisinart.com from June 2009 through March 2026 for between $8 and $20."], "injuries": "Conair is aware of at least 54 reports and reviews where small wire bristles detached from the grill brushes, including three reports of consumers who swallowed metal bristles and sought medical treatment to remove the bristles from their digestive tract or throat.", "source_url": "https://cpsc.gov/Recalls/2026/Conair-Expands-Recall-of-Cuisinart-Grill-Brushes-Due-to-Ingestion-Hazard-Over-3-6-Million-Brushes-Now-Recalled", "url": "https://recallledger.net/recalls/product-26717-conair-expands-recall-of-cuisinart-grill-brushes-due-to-ingestion-haza/"}, {"id": "fda-food-h-1257-2026", "source": "FDA", "category": "food", "recall_number": "H-1257-2026", "title": "Get Fresh Produce Jalapeno Peppers.  Item 01896 - 2 lb. box recall (GET FRESH PRODUCE)", "product": "Get Fresh Produce Jalapeno Peppers.  Item 01896 - 2 lb. box; Item 01894 - 10 lb. box", "reason": "Potential Salmonella contamination", "hazard_level": "Class I", "company": "GET FRESH PRODUCE", "company_location": "Bartlett, IL, United States", "date": "2026-08-05", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "IL, IN, MI, WI", "states": ["IL", "IN", "MI", "WI"], "nationwide": false, "quantity": "802 cases", "codes": "21621908 21621908-X0 21673911-X0 21692806 21541606 21541606-X1 21542008-X0 21541606-X0 21722002-X0 21458408-X0 21542008-X2 21621908-X1 21673911-X1", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1257-2026%22", "url": "https://recallledger.net/recalls/food-h-1257-2026-get-fresh-produce-jalapeno-peppers-item-01896-2-lb-box-item-0189/"}, {"id": "fda-food-h-1256-2026", "source": "FDA", "category": "food", "recall_number": "H-1256-2026", "title": "Dairyland Produce recall (Dairyland Produce, LLC)", "product": "Dairyland Produce, LLC Pepper Jalapeno, repackaged into the following sized clear plastic bags:   1.  1 lb., item number 01213, UPC 0009907729    2.  3 lbs., item number 02611, UPC 0009902703;     3.  5 lbs., item number 72618, UPC 0009900168;  and   4.  10 lbs., item number 71537, UPC 0009900167.   Only the 5 lb. packaging is available to consumers and retail stores.", "reason": "Jalapenos may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "Dairyland Produce, LLC", "company_location": "Dallas, TX, United States", "date": "2026-08-05", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "LA, TX", "states": ["LA", "TX"], "nationwide": false, "quantity": "7,456 lbs. total", "codes": "Lot Codes:  X2741775, X2741859, X2744163, X2744706, X2746349, X2746490, X2748743.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1256-2026%22", "url": "https://recallledger.net/recalls/food-h-1256-2026-dairyland-produce-llc-pepper-jalapeno-repackaged-into-the-following/"}, {"id": "fda-food-h-1255-2026", "source": "FDA", "category": "food", "recall_number": "H-1255-2026", "title": "Whole Foods Mango Pineapple Salsa sold as a condiment in Caribbean Mango Pineapple... recall (WFM Purchasing, LP)", "product": "Whole Foods Mango Pineapple Salsa sold as a condiment in Caribbean Mango Pineapple Turkey Burger.  Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  25867600000, 21195900000, 46000040275, 27578600000.   Packed for Whole Foods Market, 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/9/2026 - 8/14/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1255-2026%22", "url": "https://recallledger.net/recalls/food-h-1255-2026-whole-foods-mango-pineapple-salsa-sold-as-a-condiment-in-caribbean-man/"}, {"id": "fda-food-h-1254-2026", "source": "FDA", "category": "food", "recall_number": "H-1254-2026", "title": "Whole Foods Salsa recall (WFM Purchasing, LP)", "product": "Whole Foods Salsa, Heirloom Tomato.  Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/9/2026 - 8/14/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1254-2026%22", "url": "https://recallledger.net/recalls/food-h-1254-2026-whole-foods-salsa-heirloom-tomato-keep-refrigerated-packed-in-var/"}, {"id": "fda-food-h-1253-2026", "source": "FDA", "category": "food", "recall_number": "H-1253-2026", "title": "Whole Foods Trio Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Trio Dip, Contains Pico de Gallo, Guacamole, Salsa.  Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  25926000000, 85001178876, 26383300000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1253-2026%22", "url": "https://recallledger.net/recalls/food-h-1253-2026-whole-foods-trio-dip-contains-pico-de-gallo-guacamole-salsa-keep/"}, {"id": "fda-food-h-1252-2026", "source": "FDA", "category": "food", "recall_number": "H-1252-2026", "title": "Whole Foods Spicy Guacamole Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Spicy Guacamole Dip, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  21212000000, 21211900000, 25138200000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1252-2026%22", "url": "https://recallledger.net/recalls/food-h-1252-2026-whole-foods-spicy-guacamole-dip-keep-refrigerated-packed-in-various/"}, {"id": "fda-food-h-1251-2026", "source": "FDA", "category": "food", "recall_number": "H-1251-2026", "title": "Whole Foods Roasted Corn Guacamole Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Roasted Corn Guacamole Dip, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  27132500000, 24075300000, 29956000000, 29533500000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1251-2026%22", "url": "https://recallledger.net/recalls/food-h-1251-2026-whole-foods-roasted-corn-guacamole-dip-keep-refrigerated-packed-in/"}, {"id": "fda-food-h-1250-2026", "source": "FDA", "category": "food", "recall_number": "H-1250-2026", "title": "Whole Foods Pomegranate Guacamole Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Pomegranate Guacamole Dip, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  27908100000, 27908500000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1250-2026%22", "url": "https://recallledger.net/recalls/food-h-1250-2026-whole-foods-pomegranate-guacamole-dip-keep-refrigerated-packed-in-v/"}, {"id": "fda-food-h-1249-2026", "source": "FDA", "category": "food", "recall_number": "H-1249-2026", "title": "Whole Foods Medium Pico de Gallo Guacamole Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  29802800000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1249-2026%22", "url": "https://recallledger.net/recalls/food-h-1249-2026-whole-foods-medium-pico-de-gallo-guacamole-dip-keep-refrigerated-pa/"}, {"id": "fda-food-h-1248-2026", "source": "FDA", "category": "food", "recall_number": "H-1248-2026", "title": "Whole Foods Spicy Guacamole Dip No Tomatoes recall (WFM Purchasing, LP)", "product": "Whole Foods Spicy Guacamole Dip No Tomatoes, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  25745200000, 284324000000, 23501500000, 25744900000.   Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1248-2026%22", "url": "https://recallledger.net/recalls/food-h-1248-2026-whole-foods-spicy-guacamole-dip-no-tomatoes-keep-refrigerated-packe/"}, {"id": "fda-food-h-1247-2026", "source": "FDA", "category": "food", "recall_number": "H-1247-2026", "title": "Whole Foods Mild Guacamole Dip No Tomatoes recall (WFM Purchasing, LP)", "product": "Whole Foods Mild Guacamole Dip No Tomatoes, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  24293900000, 25745000000, 24367500000, 25658600000,  Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1247-2026%22", "url": "https://recallledger.net/recalls/food-h-1247-2026-whole-foods-mild-guacamole-dip-no-tomatoes-keep-refrigerated-packed/"}, {"id": "fda-food-h-1246-2026", "source": "FDA", "category": "food", "recall_number": "H-1246-2026", "title": "Whole Foods Mild Guacamole Dip recall (WFM Purchasing, LP)", "product": "Whole Foods Mild Guacamole Dip, Keep Refrigerated.  Packed in various sized clear plastic containers.   Product is weighed and a finished product label is applied.  Products contain the following PLU Cods located under label bar code:  21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH  44313 or 4301 W. William Cannon, Austin, TX  78749.", "reason": "Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "AR, IA, IL, IN, KY, LA, MI, MN, MO, OH, OK, TX, WI", "states": ["AR", "IA", "IL", "IN", "KY", "LA", "MI", "MN", "MO", "OH", "OK", "TX", "WI"], "nationwide": false, "quantity": "12,995 units total", "codes": "Best Before/By Date:  8/7/2026 - 8/12/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1246-2026%22", "url": "https://recallledger.net/recalls/food-h-1246-2026-whole-foods-mild-guacamole-dip-keep-refrigerated-packed-in-various/"}, {"id": "fda-food-h-1245-2026", "source": "FDA", "category": "food", "recall_number": "H-1245-2026", "title": "Gifford's HomeMaine ice cream brand POWER PLAY FUDGE recall (Gifford's Dairy, Inc.)", "product": "Gifford's HomeMaine ice cream brand POWER PLAY FUDGE; ONE QUART (946 mL); UPC: 8 60864 00030 7", "reason": "Potential foreign object contamination: rubber pieces", "hazard_level": "Class II", "company": "Gifford's Dairy, Inc.", "company_location": "Skowhegan, ME, United States", "date": "2026-08-14", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "MA, ME, VT", "states": ["MA", "ME", "VT"], "nationwide": false, "quantity": "3,585 units", "codes": "Lot Code: 26184. Best By date: 08/27/27.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1245-2026%22", "url": "https://recallledger.net/recalls/food-h-1245-2026-gifford-s-homemaine-ice-cream-brand-power-play-fudge-one-quart-946-m/"}, {"id": "fda-food-h-1244-2026", "source": "FDA", "category": "food", "recall_number": "H-1244-2026", "title": "Product is Potato Sourdough Bread and sold under three following names:  Potato Market... recall (Grand Central Bakery - Oregon Inc. dba Grand Central Bakery, Inc.)", "product": "Product is Potato Sourdough Bread and sold under three following names:  Potato Market Loaf 20oz. UPC 733163001576, product is sold at grocery stores with paper packaging. Label declares Potato Grand Central Rustic Breads ***A hearty sourdough loaf made with house-roasted potatoes. ***\"  Potato Table Loaf 20oz. No UPC. Product is sold direct to consumer at Grand Central Cafe stores and wholesalers without paper packaging.  Mini Potato Loaf 12oz. No UPC. Product is sold at grocery stores and wholesalers without paper packaging.", "reason": "Foreign object: May contain metal pieces", "hazard_level": "Class II", "company": "Grand Central Bakery - Oregon Inc. dba Grand Central Bakery, Inc.", "company_location": "Portland, OR, United States", "date": "2026-08-12", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "Distributed in WA only.", "states": ["WA"], "nationwide": false, "quantity": "Potato Market Loaf 20oz = 288 units; Potato Table Loaf 20oz = 58 units; Mini Potato Loaf 12oz = 171 units", "codes": "No codes. Product was sold on 8/10/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1244-2026%22", "url": "https://recallledger.net/recalls/food-h-1244-2026-product-is-potato-sourdough-bread-and-sold-under-three-following-names/"}, {"id": "fda-food-h-1243-2026", "source": "FDA", "category": "food", "recall_number": "H-1243-2026", "title": "VITASIA ASIAN STYLE WOK SPICE MIX recall (Lidl US TRADING)", "product": "VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLIC", "reason": "Salmonella. The firm received a positive test result of Salmonella in the product.", "hazard_level": "Class I", "company": "Lidl US TRADING", "company_location": "Arlington, VA, United States", "date": "2026-08-10", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "Washington DC, DE, GA, MD, NC, NJ, NY, PA, SC, VA.", "states": ["DC", "DE", "GA", "MD", "NC", "NJ", "NY", "PA", "SC", "VA"], "nationwide": false, "quantity": "2,040 containers", "codes": "Lot # 155846, Best if Used By JUN 2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1243-2026%22", "url": "https://recallledger.net/recalls/food-h-1243-2026-vitasia-asian-style-wok-spice-mix-net-wt-1-58-oz-45g-upc-4-335619-35/"}, {"id": "fda-food-h-1231-2026", "source": "FDA", "category": "food", "recall_number": "H-1231-2026", "title": "Protein Cereal Cocoa Crunch. Shelf stable recall (Nutrient Foods, LLC)", "product": "Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC   Not for individual retail sale", "reason": "Soy not declared in the contains statement.", "hazard_level": "Class II", "company": "Nutrient Foods, LLC", "company_location": "Reno, NV, United States", "date": "2026-08-03", "report_date": "2026-08-26", "status": "Completed", "distribution": "Product was distributed to the following states: FL, IN, MD, MA, MO, NJ, NC, OK, PA, and TX.", "states": ["FL", "IN", "MA", "MD", "MO", "NC", "NJ", "OK", "PA", "TX"], "nationwide": false, "quantity": "16 kits", "codes": "Best if used By on package: 030651,  Best if Used by on Kit: 030951", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1231-2026%22", "url": "https://recallledger.net/recalls/food-h-1231-2026-protein-cereal-cocoa-crunch-shelf-stable-ready-to-eat-cereal-product/"}, {"id": "fda-drug-d-0788-2026", "source": "FDA", "category": "drug", "recall_number": "D-0788-2026", "title": "Morphine Sulfate Injection recall (Fresenius Kabi USA, LLC)", "product": "Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11", "reason": "Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.", "hazard_level": "Class I", "company": "Fresenius Kabi USA, LLC", "company_location": "Lake Zurich, IL, United States", "date": "2026-08-04", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "Nationwide within the USA.", "states": [], "nationwide": true, "quantity": "625500 syringes", "codes": "Lot #: 6402820, Exp. Date 12/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0788-2026%22", "url": "https://recallledger.net/recalls/drug-d-0788-2026-morphine-sulfate-injection-usp-2-mg-ml-1-ml-single-dose-simplist-p/"}, {"id": "fda-drug-d-0771-2026", "source": "FDA", "category": "drug", "recall_number": "D-0771-2026", "title": "Carbamazepine Tablets recall (Golden State Medical Supply Inc.)", "product": "Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA", "reason": "CGMP deviations: tablets with black specks.", "hazard_level": "Class II", "company": "Golden State Medical Supply Inc.", "company_location": "Camarillo, CA, United States", "date": "2026-08-07", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "USA Nationwide", "states": [], "nationwide": true, "quantity": "1200 bottles", "codes": "Lot #: a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0771-2026%22", "url": "https://recallledger.net/recalls/drug-d-0771-2026-carbamazepine-tablets-usp-200mg-packaged-in-a-1000-count-bottles-n/"}, {"id": "fda-drug-d-0770-2026", "source": "FDA", "category": "drug", "recall_number": "D-0770-2026", "title": "Carbamazepine Tablets recall (SUN PHARMACEUTICAL INDUSTRIES INC)", "product": "Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.", "reason": "CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing", "hazard_level": "Class II", "company": "SUN PHARMACEUTICAL INDUSTRIES INC", "company_location": "Princeton, NJ, United States", "date": "2026-08-03", "report_date": "2026-08-26", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "1968 Bottles (1000Tablets/Bottle)", "codes": "Lot # AD94033, Exp Date: 5/31/2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0770-2026%22", "url": "https://recallledger.net/recalls/drug-d-0770-2026-carbamazepine-tablets-usp-200mg-1000-count-bottles-rx-only-manufa/"}, {"id": "cpsc-26716", "source": "CPSC", "category": "consumer-product", "recall_number": "26716", "title": "CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories Due to Risk of Injury from Laceration or Impact Hazards", "product": "FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories", "reason": "The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards.", "hazard_level": null, "company": "CCM Hockey U.S., Inc., of Maple Grove, Illinois", "company_location": "China", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at Monkey Sports, Play It Again Sports, Pure Hockey and independent sporting goods and online at https://us.ccmhockey.com/ from May 2024 through April 2026 for about $120 for the Hybrid Visor and about $55 for the Replacement Visor accessories.", "states": [], "nationwide": true, "quantity": "About 12,957", "codes": "", "remedy": "Consumers should stop using the recalled visors and visor accessories immediately and return the products to the nearest participating retailer for a free replacement. Consumers can choose from the FV1 full visor, FM780 combo cage, or FM580 combo cage. To find your nearest participating retailer, go to https://us.ccmhockey.com/product/storelocator. Consumers without access to a participating retailer should contact CCM directly and CCM will send a return prepaid envelope for the return of the recalled product. CCM will ship a replacement upon receipt of the returned recalled product. Replace", "retailers": ["Monkey Sports, Play It Again Sports, Pure Hockey and independent sporting goods and online at https://us.ccmhockey.com/ from May 2024 through April 2026 for about $120 for the Hybrid Visor and about $55 for the Replacement Visor accessories."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/CCM-Hockey-US-Recalls-FMHVR-Hybrid-Visors-and-ACCHVR-Replacement-Visor-Accessories-Due-to-Risk-of-Injury-from-Laceration-or-Impact-Hazards", "url": "https://recallledger.net/recalls/product-26716-ccm-hockey-u-s-recalls-fmhvr-hybrid-visors-and-acchvr-replacement-vis/"}, {"id": "cpsc-26715", "source": "CPSC", "category": "consumer-product", "recall_number": "26715", "title": "Workbless Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and Electrocution Hazards", "product": "Workbless Electric Pressure Washers", "reason": "The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.", "hazard_level": null, "company": "Guangzhou Ao Lian Ya Wang Luo Ke Ji You Xian Gong Si, dba Workbless, of China", "company_location": "China", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at Amazon.com, BestBuy, Kohls, Lowe's, Overstock, Target and Walmart from April 2025 through July 2026 for between $97 and $140.", "states": [], "nationwide": true, "quantity": "About 2,200 (In addition, about 657 in Canada)", "codes": "", "remedy": "Consumers should stop using the recalled pressure washers immediately and contact Workbless for a full refund. Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to service@workbless.net. Consumers should then dispose of the destroyed recalled product. Refund", "retailers": ["Amazon.com, BestBuy, Kohls, Lowe's, Overstock, Target and Walmart from April 2025 through July 2026 for between $97 and $140."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Workbless-Pressure-Washers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Shock-and-Electrocution-Hazards", "url": "https://recallledger.net/recalls/product-26715-workbless-pressure-washers-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26714", "source": "CPSC", "category": "consumer-product", "recall_number": "26714", "title": "Koorlian Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability; Sold on Amazon by Dream Bedding Technology", "product": "Koorlian Mattresses", "reason": "The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.", "hazard_level": null, "company": "Dreams Bedding Technology PTE. Ltd., of Singapore", "company_location": "Singapore", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from November 2025 through March 2026 for between $110 and $170.", "states": [], "nationwide": true, "quantity": "About 251", "codes": "", "remedy": "Consumers should stop using the recalled mattress immediately and contact Dreams Bedding Technology to receive a free cover to put over their mattress to bring it into compliance with the mandatory flammability standards. Repair", "retailers": ["Online at Amazon.com from November 2025 through March 2026 for between $110 and $170."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Koorlian-Mattresses-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Fire-Hazard-Violate-Mandatory-Standard-for-Mattress-Flammability-Sold-on-Amazon-by-Dream-Bedding-Technology", "url": "https://recallledger.net/recalls/product-26714-koorlian-mattresses-recalled-due-to-risk-of-serious-injury-or-death-fr/"}, {"id": "cpsc-26713", "source": "CPSC", "category": "consumer-product", "recall_number": "26713", "title": "JINHEZO Mini Waterproof LED Tea Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Imported by Mystic ZO", "product": "JINHEZO Mini Waterproof LED Tea Lights", "reason": "The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.", "hazard_level": null, "company": "Shenzhen Jinhe Trade Co., Ltd., dba Mystic ZO, of China", "company_location": "China", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from March 2024 through July 2026 for between $16 to $20 per pack.", "states": [], "nationwide": true, "quantity": "About 2,798", "codes": "", "remedy": "Consumers should stop using the recalled LED Tea Lights immediately and contact Mystic Zo for a full refund. To receive a refund, consumers will be asked to email their order number or bar code number, if available, along with a photo of the tea lights disposed of in the trash to jinhemaoyi2016@sina.com. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Online at Amazon.com from March 2024 through July 2026 for between $16 to $20 per pack."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/JINHEZO-Mini-Waterproof-LED-Tea-Lights-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Consumer-Products-with-Button-Cell-Batteries-Imported-by-Mystic-ZO", "url": "https://recallledger.net/recalls/product-26713-jinhezo-mini-waterproof-led-tea-lights-recalled-due-to-risk-of-serious/"}, {"id": "cpsc-26712", "source": "CPSC", "category": "consumer-product", "recall_number": "26712", "title": "Goal Zero Recalls YETI 3000X Power Stations Due to Serious Risk of Injury from Fire and Burn Hazards", "product": "Goal Zero YETI 3000X Portable Power Stations", "reason": "The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.", "hazard_level": null, "company": "Goal Zero, of Draper, Utah", "company_location": "China", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at REI stores nationwide and online at Costco.com, Backcountry.com, Goalzero.com and other online retailers from May 2020 through August 2025 for about $3,00.", "states": [], "nationwide": true, "quantity": "About 46,200", "codes": "", "remedy": "Consumers should stop using the power stations immediately and install the free repair in the form of a firmware update available through the Goal Zero application or contact Goal Zero for firmware installation at no cost. Repair", "retailers": ["REI stores nationwide and online at Costco.com, Backcountry.com, Goalzero.com and other online retailers from May 2020 through August 2025 for about $3,00."], "injuries": "Goal Zero has received four reports of the power stations catching fire, overheating and smoking. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Goal-Zero-Recalls-YETI-3000X-Power-Stations-Due-to-Serious-Risk-of-Injury-from-Fire-and-Burn-Hazards", "url": "https://recallledger.net/recalls/product-26712-goal-zero-recalls-yeti-3000x-power-stations-due-to-serious-risk-of-inj/"}, {"id": "cpsc-26711", "source": "CPSC", "category": "consumer-product", "recall_number": "26711", "title": "Modine Manufacturing Company Recalls Airedale Heating and Cooling Ventilation Fans Due to Fire Hazard", "product": "Ventilation Fans in ClassMate® DX Cooling and Air Source Heat Pumps and SchoolMate® Water/Ground Source Heat Pumps", "reason": "The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing a fire hazard.", "hazard_level": null, "company": "Modine Manufacturing Company, of Racine, Wisconsin", "company_location": "United States", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at Independent dealers nationwide from August 2013 through January 2026 for between $15,000 and $25,000. The ventilation fans are also sold separately through independent dealers for between $250 and $450.", "states": [], "nationwide": true, "quantity": "About 6,061 (In addition, about 735 were sold in Canada)", "codes": "", "remedy": "Consumers should stop using the recalled heat pumps immediately and contact Modine Manufacturing Company for written instructions to unplug the recalled ventilation fan or to switch the internal disconnect in the fan to the \"off\" position. Consumers should contact their Modine distributor to arrange for their free inspection and service. Service technicians will inspect and repair or replace the recalled heating and cooling OA/EA ventilation fans in all units. Repair", "retailers": ["Independent dealers nationwide from August 2013 through January 2026 for between $15,000 and $25,000. The ventilation fans are also sold separately through independent dealers for between $250 and $450."], "injuries": "Modine has received 11 reports of incidents that resulted in fires, totaling at least $2.7 million in property damage. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Modine-Manufacturing-Company-Recalls-Airedale-Heating-and-Cooling-Ventilation-Fans-Due-to-Fire-Hazard", "url": "https://recallledger.net/recalls/product-26711-modine-manufacturing-company-recalls-airedale-heating-and-cooling-vent/"}, {"id": "cpsc-26710", "source": "CPSC", "category": "consumer-product", "recall_number": "26710", "title": "KTM North America Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death from Crash Hazard", "product": "GASGAS and Husqvarna Off-Road Motorcycles", "reason": "The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash hazard.", "hazard_level": null, "company": "KTM North America Inc., of Amherst, Ohio", "company_location": "Austria", "date": "2026-08-20", "report_date": "2026-08-20", "status": "Announced", "distribution": "Sold in the United States at GASGAS and Husqvarna authorized dealers nationwide from September 2020 through June 2023 for between $7,300 and $13,000.", "states": [], "nationwide": true, "quantity": "About 21,040 (In addition, about 4,140 were sold in Canada)", "codes": "", "remedy": "Consumers should stop riding the recalled motorcycles immediately and contact an authorized GASGAS or Husqvarna Motorcycle dealer to schedule a free repair at the dealership. Repair", "retailers": ["GASGAS and Husqvarna authorized dealers nationwide from September 2020 through June 2023 for between $7,300 and $13,000."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/KTM-North-America-Recalls-Off-Road-Motorcycles-Due-to-Risk-of-Serious-Injury-or-Death-from-Crash-Hazard", "url": "https://recallledger.net/recalls/product-26710-ktm-north-america-recalls-off-road-motorcycles-due-to-risk-of-serious/"}, {"id": "fda-drug-d-0763-2026", "source": "FDA", "category": "drug", "recall_number": "D-0763-2026", "title": "SILDENAFIL CITRATE USP recall (Shoolin Pharma Chem LLP)", "product": "SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only \" For Prescription Compounding Only\",  Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.", "reason": "CGMP Deviations:Noted during FDA inspection", "hazard_level": "Class II", "company": "Shoolin Pharma Chem LLP", "company_location": "Kadi, India", "date": "2026-08-03", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "25 KG, 25 X 1.00 KG bags", "codes": "Lot: SDC2505001, Date of Expiry: April 30, 2030.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0763-2026%22", "url": "https://recallledger.net/recalls/drug-d-0763-2026-sildenafil-citrate-usp-1-00kg-1-00kg-bag-net-wt-rx-only-for-presc/"}, {"id": "fda-drug-d-0762-2026", "source": "FDA", "category": "drug", "recall_number": "D-0762-2026", "title": "TADALAFIL USP recall (Shoolin Pharma Chem LLP)", "product": "TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, \"For Prescription Compounding Only\",  Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08", "reason": "CGMP Deviations:Noted during FDA inspection", "hazard_level": "Class II", "company": "Shoolin Pharma Chem LLP", "company_location": "Kadi, India", "date": "2026-08-03", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "1KG - 20 X 1KG(1000gm) bags", "codes": "Batch TLF2506001, Date of Expiry: May 31, 2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0762-2026%22", "url": "https://recallledger.net/recalls/drug-d-0762-2026-tadalafil-usp-1-00-kg-1kg-1000gm-bag-rx-only-for-prescription-co/"}, {"id": "fda-drug-d-0761-2026", "source": "FDA", "category": "drug", "recall_number": "D-0761-2026", "title": "TADALAFIL USP recall (Shoolin Pharma Chem LLP)", "product": "TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, \"For Prescription Compounding Only\",  Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.", "reason": "CGMP Deviations:Noted during FDA inspection", "hazard_level": "Class II", "company": "Shoolin Pharma Chem LLP", "company_location": "Kadi, India", "date": "2026-08-03", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "20 KG, 40 X 0.500KG(500gm) bags", "codes": "Batch TLF2506001, Date of Expiry: May 31, 2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0761-2026%22", "url": "https://recallledger.net/recalls/drug-d-0761-2026-tadalafil-usp-0-500-kg-0-500kg-500gm-bag-rx-only-for-prescriptio/"}, {"id": "fda-drug-d-0760-2026", "source": "FDA", "category": "drug", "recall_number": "D-0760-2026", "title": "TADALAFIL USP recall (Shoolin Pharma Chem LLP)", "product": "TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, \"For Prescription Compounding Only\",  Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.", "reason": "CGMP Deviations:Noted during FDA inspection", "hazard_level": "Class II", "company": "Shoolin Pharma Chem LLP", "company_location": "Kadi, India", "date": "2026-08-03", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "1KG - 100-0.1KG(100gm) bags", "codes": "Lot: TLF2506001, Date of Expiry: May 31, 2028.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0760-2026%22", "url": "https://recallledger.net/recalls/drug-d-0760-2026-tadalafil-usp-0-100-kg-0-1kg-100gm-bag-rx-only-for-prescription/"}, {"id": "fda-drug-d-0759-2026", "source": "FDA", "category": "drug", "recall_number": "D-0759-2026", "title": "SILDENAFIL CITRATE USP recall (Shoolin Pharma Chem LLP)", "product": "SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY \"FOR Prescription Compounding Only\", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India,  (CAS NO. 171599-83-0) NDC 85702-001-05", "reason": "CGMP Deviations:Noted during FDA inspection", "hazard_level": "Class II", "company": "Shoolin Pharma Chem LLP", "company_location": "Kadi, India", "date": "2026-08-03", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "25KG, 250-1gm bags", "codes": "Batch SDC2505001, Date of Expiry: April 30, 2030.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0759-2026%22", "url": "https://recallledger.net/recalls/drug-d-0759-2026-sildenafil-citrate-usp-0-100-kg-100-gm-bag-net-wt-rx-only-for-pres/"}, {"id": "fda-drug-d-0746-2026", "source": "FDA", "category": "drug", "recall_number": "D-0746-2026", "title": "Diovan recall (Novartis Pharmaceuticals Corporation)", "product": "Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34", "reason": "Failed Dissolution Specifications", "hazard_level": "Class II", "company": "Novartis Pharmaceuticals Corporation", "company_location": "East Hanover, NJ, United States", "date": "2026-08-04", "report_date": "2026-08-19", "status": "Ongoing", "distribution": "US Nationwide", "states": [], "nationwide": true, "quantity": "", "codes": "Lot AV5913C, Expiry: 6/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0746-2026%22", "url": "https://recallledger.net/recalls/drug-d-0746-2026-diovan-valsartan-160-mg-90-tablets-rx-only-manufactured-by-pathe/"}, {"id": "cpsc-26702", "source": "CPSC", "category": "consumer-product", "recall_number": "26702", "title": "Hampton Bay Halwin 52-Inch Ceiling Fans Recalled Due to Impact and Injury Hazards; Manufactured by Youngo Limited", "product": "Hampton Bay Halwin 52-inch Indoor/Outdoor Ceiling Fans", "reason": "The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.", "hazard_level": null, "company": "Youngo Limited, of Huizhou, China", "company_location": "China, China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at The Home Depot stores nationwide and online from January 2023 through October 2025 for about $180.", "states": [], "nationwide": true, "quantity": "About 9,460", "codes": "UPCs: 840059614922, 840059615370", "remedy": "Consumers should stop using the recalled ceiling fans immediately and contact Youngo for either a full refund by ACH payment or store credit in the form of a Home Depot gift card. To receive either option, consumers should contact Youngo with proof of purchase or a photograph of the serial number (located inside the mounting plate of the ceiling fan) and a photo showing proof of disposal of the product. Alternatively, consumers may return the product to a Home Depot retail store for full store credit in the form of a Home Depot gift card or refund back to the card used for purchase. Refund", "retailers": ["The Home Depot stores nationwide and online from January 2023 through October 2025 for about $180."], "injuries": "Youngo has received 11 reports of incidents involving the fan blades breaking or separating from the fan motor flywheel. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Hampton-Bay-Halwin-52-Inch-Ceiling-Fans-Recalled-Due-to-Impact-and-Injury-Hazards-Manufactured-by-Youngo-Limited", "url": "https://recallledger.net/recalls/product-26702-hampton-bay-halwin-52-inch-ceiling-fans-recalled-due-to-impact-and-inj/"}, {"id": "cpsc-26701", "source": "CPSC", "category": "consumer-product", "recall_number": "26701", "title": "Sunnyside Corporation Recalls 1-K Kerosene Heater and Appliance Fuel Containers Due to Risk of Serious Injury or Death from Flash Fire and Burn Hazard; Violates Mandatory Standards for Portable Fuel Containers", "product": "Sunnyside gallon 1-K Kerosene Heater Fluid Portable Fuel Containers", "reason": "The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mitigation devices, posing a deadly risk of flash fire and burn hazard.", "hazard_level": null, "company": "Sunnyside Corporation, of Wheeling, Illinois", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Amazon.com online and Do-It Best Hardware Stores from May 2026 through July 2026 for about $13.", "states": [], "nationwide": true, "quantity": "About 960", "codes": "", "remedy": "Consumers should stop using the recalled fuel bottles immediately, place them out of reach of children, and contact Sunnyside for a full refund. Consumers will be asked to write \"RECALLED\" with permanent marker on the bottle; and submit a photo of it to info@sunnysidecorp.com. Consumers should dispose of the fuel bottles in accordance with local and state regulations. Note: Kerosene fuel is hazardous. Fuel containers should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Amazon.com online and Do-It Best Hardware Stores from May 2026 through July 2026 for about $13."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Sunnyside-Corporation-Recalls-1-K-Kerosene-Heater-and-Appliance-Fuel-Containers-Due-to-Risk-of-Serious-Injury-or-Death-from-Flash-Fire-and-Burn-Hazard-Violates-Mandatory-Standards-for-Portable-Fuel-Containers", "url": "https://recallledger.net/recalls/product-26701-sunnyside-corporation-recalls-1-k-kerosene-heater-and-appliance-fuel-c/"}, {"id": "cpsc-26700", "source": "CPSC", "category": "consumer-product", "recall_number": "26700", "title": "Fastbuy Recalls Zimtown Portable Gas and Fuel Cans Due to Risk of Serious Injury or Death from Burn Hazard and Child Poisoning; Violate Mandatory Standard for Portable Fuel Containers", "product": "Zimtown Portable Gas and Fuel Cans", "reason": "The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child-resistant, posing a risk of burns and poisoning to children.", "hazard_level": null, "company": "Fastbuy Inc., dba Zimtown, of Metuchen, New Jersey", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Walmart.com and Zimtown.com from May 2026 through July 2026 for between $32 and $63.", "states": [], "nationwide": true, "quantity": "About 200", "codes": "", "remedy": "Consumers should stop using the gas and fuel containers immediately and contact Fastbuy for a full refund. Consumers should disassemble the spout, cut it into pieces with scissors and dispose of it separately from the container. Consumers will be asked to write \"RECALLED\" on the container and submit photos of the product to ZimtownFuelCanrecall@outlook.com separately. Refund", "retailers": ["Online at Walmart.com and Zimtown.com from May 2026 through July 2026 for between $32 and $63."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Fastbuy-Recalls-Zimtown-Portable-Gas-and-Fuel-Cans-Due-to-Risk-of-Serious-Injury-or-Death-from-Burn-Hazard-and-Child-Poisoning-Violate-Mandatory-Standard-for-Portable-Fuel-Containers", "url": "https://recallledger.net/recalls/product-26700-fastbuy-recalls-zimtown-portable-gas-and-fuel-cans-due-to-risk-of-seri/"}, {"id": "cpsc-26699", "source": "CPSC", "category": "consumer-product", "recall_number": "26699", "title": "SUGIFT Recalls SUGIFT Pressure Washers Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards", "product": "SUGIFT Electric Pressure Washers, Model LTBBHG006", "reason": "The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.", "hazard_level": null, "company": "SUGIFT, INC., of Albany, NY", "company_location": "", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at bestbuy.com from July 2025 through July 2026 for about $155.", "states": [], "nationwide": true, "quantity": "13", "codes": "", "remedy": "Consumers should stop using the recalled pressure washers immediately and contact SUGIFT for a full refund. Consumers will be asked to destroy the pressure washer by cutting the power cord in half (the product should be completely turned off and unplugged from power outlet) and send a photo of the destroyed pressure washer to steven@sugift.net. Consumers should then dispose of the destroyed recalled product. Refund", "retailers": ["Online at bestbuy.com from July 2025 through July 2026 for about $155."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/SUGIFT-Recalls-SUGIFT-Pressure-Washers-Due-to-Serious-Risk-of-Injury-or-Death-From-Shock-and-Electrocution-Hazards", "url": "https://recallledger.net/recalls/product-26699-sugift-recalls-sugift-pressure-washers-due-to-serious-risk-of-injury-o/"}, {"id": "cpsc-26698", "source": "CPSC", "category": "consumer-product", "recall_number": "26698", "title": "CuberShop Magnetic Speed Cubes Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Imported by SKY CUBE HK", "product": "CuberShop Magnetic Stickerless Speed Cubes, model YJ MGC 5×5", "reason": "The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.", "hazard_level": null, "company": "SKY CUBE HK, of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from April 2025 through June 2025 for between $20 and $25.", "states": [], "nationwide": true, "quantity": "About 132", "codes": "", "remedy": "Consumers should take the recalled loose magnets away from children, stop using them immediately, and contact SKY CUBE HK for information on how to receive a $5 refund. Consumers will be asked to throw away the magnets and email a photo of the disposed magnets to recall@cubershop.com. Consumers may keep the cube. Refund", "retailers": ["Online at Amazon.com from April 2025 through June 2025 for between $20 and $25."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/CuberShop-Magnetic-Speed-Cubes-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnet-Ingestion-Violate-Mandatory-Standard-for-Toys-Imported-by-SKY-CUBE-HK", "url": "https://recallledger.net/recalls/product-26698-cubershop-magnetic-speed-cubes-recalled-due-to-risk-of-serious-injury/"}, {"id": "cpsc-26697", "source": "CPSC", "category": "consumer-product", "recall_number": "26697", "title": "Shengsen Prank Sound Makers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Shengsen Toys", "product": "Shengsen Prank Sound Maker", "reason": "The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.", "hazard_level": null, "company": "Yiwushishengsengongyipinyouxiangongsi, dba Shengsen Toys, of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from April 2024 through April 2026 for about $8.", "states": [], "nationwide": true, "quantity": "About 667", "codes": "", "remedy": "Consumers should stop using the sound maker immediately and contact Shengsen Toys for a full refund. Consumers will be asked to properly dispose of the sound maker into the trash and send a photo of the disposed product to ywpower@outlook.com. Note: Button cell and coin batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Online at Amazon.com from April 2024 through April 2026 for about $8."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Shengsen-Prank-Sound-Makers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Consumer-Products-with-Coin-Batteries-Imported-by-Shengsen-Toys", "url": "https://recallledger.net/recalls/product-26697-shengsen-prank-sound-makers-recalled-due-to-risk-of-serious-injury-or/"}, {"id": "cpsc-26696", "source": "CPSC", "category": "consumer-product", "recall_number": "26696", "title": "Ritchey Design Recalls Carbon Bicycle Forks Due to Risk of Serious Injury or Death from Fall and Crash Hazards", "product": "Ritchey Carbon Fiber Bicycle Forks", "reason": "The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's front wheel, posing a risk of serious injury or death from a fall and crash hazard.", "hazard_level": null, "company": "Ritchey Design, of Reno, Nevada", "company_location": "Taiwan", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Performance Bike, Chico CA, Adrenaline Bikes, Orange CA, Excel Sports Boulder, Boulder, CO and other bicycle retailers nationwide and on-line including ritcheylogic.com from July 2024 through June 2026 for between $660 and $700 (individual carbon bicycle fork) and between $1,760 and $3,500 (bike frames with carbon bicycle forks).", "states": [], "nationwide": true, "quantity": "About 775", "codes": "", "remedy": "Consumers are asked to stop using the bicycles equipped with the recalled fork immediately. Please inspect the front crown hole for any attached racks or accessories. The threaded hole located above the front wheel should be closed immediately. Consumers should register at https://ritcheylogic.com/support/recall to receive a free Ritchey Fork Crown Hole Closure Kit with instructions. All carbon bicycle forks with crown mounting holes are included in the recall. Repair", "retailers": ["Performance Bike, Chico CA, Adrenaline Bikes, Orange CA, Excel Sports Boulder, Boulder, CO and other bicycle retailers nationwide and on-line including ritcheylogic.com from July 2024 through June 2026 for between $660 and $700 (individual carbon bicycle fork) and between $1,760 and $3,500 (bike frames with carbon bicycle forks)."], "injuries": "The firm has received one report of the alloy insert in the crown hole coming loose. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Ritchey-Design-Recalls-Carbon-Bicycle-Forks-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-and-Crash-Hazards", "url": "https://recallledger.net/recalls/product-26696-ritchey-design-recalls-carbon-bicycle-forks-due-to-risk-of-serious-inj/"}, {"id": "cpsc-26695", "source": "CPSC", "category": "consumer-product", "recall_number": "26695", "title": "Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability; Sold on Amazon by Qabefy", "product": "Qabefy Mattresses", "reason": "The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.", "hazard_level": null, "company": "Guangzhoushi Jiatian Trading Co., Ltd, dba Qabefy, of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from November 2025 through March 2026 for between $120 and $140.", "states": [], "nationwide": true, "quantity": "About 774", "codes": "", "remedy": "Consumers should stop using the recalled mattresses immediately and contact Qabefy for a full refund. Consumers will be asked to destroy the mattress, by writing in permanent marker \"Recalled,\" their name and the current date on the mattress's top surface, and to email a photo of the destroyed mattress to Sixiang2023@gmail.com. Consumers should then dispose of the recalled product. Refund", "retailers": ["Online at Amazon.com from November 2025 through March 2026 for between $120 and $140."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Mattresses-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Fire-Hazard-Violate-Mandatory-Standard-for-Mattress-Flammability-Sold-on-Amazon-by-Qabefy", "url": "https://recallledger.net/recalls/product-26695-mattresses-recalled-due-to-risk-of-serious-injury-or-death-from-fire-h/"}, {"id": "cpsc-26694", "source": "CPSC", "category": "consumer-product", "recall_number": "26694", "title": "GigaCloud Technology USA Recalls Merax Murphy Beds Due to Risk of Serious Injury or Death from Impact and Crush Hazards", "product": "Merax Full-Size and Twin-Size Murphy Beds", "reason": "During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.", "hazard_level": null, "company": "GigaCloud Technology (USA) Inc., of El Monte, California", "company_location": "Vietnam", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com, HomeDepot.com, Wayfair.com, Walmart.com, Target.com, Overstock.com, Temu.com and other websites from May 2024 through February 2026 for between $900 and $1,100.", "states": [], "nationwide": true, "quantity": "About 1,250", "codes": "", "remedy": "Consumers should stop using the recalled Murphy beds immediately and contact GigaCloud Technology for a free repair kit. Consumers that have not assembled the Murphy bed will receive a repair kit consisting of unloaded piston springs, updated assembly instructions and inspection instructions. Consumers that have assembled the Murphy bed will receive inspection instructions. If the consumer determines that the Murphy bed is assembled incorrectly, GigaCloud Technology will provide the consumer with a professional installer to correct or complete the installation, at no cost to the consumer. Repair", "retailers": ["Online at Amazon.com, HomeDepot.com, Wayfair.com, Walmart.com, Target.com, Overstock.com, Temu.com and other websites from May 2024 through February 2026 for between $900 and $1,100."], "injuries": "The firm has received two reports of the Murphy beds falling during assembly, when the Murphy beds were not anchored to the wall, resulting in two injured consumers. One consumer sustained bruising to his head, neck and right shoulder and one consumer sustained a hit to his head, and scrapes and bruises on his arms.", "source_url": "https://www.cpsc.gov/Recalls/2026/GigaCloud-Technology-USA-Recalls-Merax-Murphy-Beds-Due-to-Risk-of-Serious-Injury-or-Death-from-Impact-and-Crush-Hazards", "url": "https://recallledger.net/recalls/product-26694-gigacloud-technology-usa-recalls-merax-murphy-beds-due-to-risk-of-seri/"}, {"id": "cpsc-26693", "source": "CPSC", "category": "consumer-product", "recall_number": "26693", "title": "Yamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash Hazard; Violates Mandatory Standard for ATVs", "product": "Youth All-Terrain Vehicles (ATVs), model XW-A19", "reason": "The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting device is not set to the restricted speed required for children ages six (6) and older, posing a crash hazard. Additionally, the ATVs are missing the required rear safety reflectors, reducing visibility of the youth ATV to other vehicles, posing a deadly crash hazard.", "hazard_level": null, "company": "Yongkang Dingchang Industry and Trade Co., Ltd, of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com and Walmart.com from September 2025 through April 2026 for between $500 to $580.", "states": [], "nationwide": true, "quantity": "About 1,050 (Yamazuki vehicles model XW-A17 were previously recalled in June 2026)", "codes": "", "remedy": "Consumers should stop using the recalled youth ATVs immediately and contact Yamazuki for a free repair kit, including shipping. The repair kit consists of replacement parking brake latches, rear safety reflectors, an owner's manual storage bag and repair tools. Repair", "retailers": ["Online at Amazon.com and Walmart.com from September 2025 through April 2026 for between $500 to $580."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Yamazuki-Recalls-Youth-All-Terrain-Vehicles-ATVs-Due-to-Risk-of-Serious-Injury-or-Death-from-Crash-Hazard-Violates-Mandatory-Standard-for-ATVs", "url": "https://recallledger.net/recalls/product-26693-yamazuki-recalls-youth-all-terrain-vehicles-atvs-due-to-risk-of-seri/"}, {"id": "cpsc-26692", "source": "CPSC", "category": "consumer-product", "recall_number": "26692", "title": "COMMOWNER Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by AZ Home Concept", "product": "COMMOWNER Electric Pressure Washers, model numbers HD14P-Z and HX18", "reason": "The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.", "hazard_level": null, "company": "AZ Home Concept Ltd., of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com in April 2026 for about $150.", "states": [], "nationwide": true, "quantity": "1,694", "codes": "", "remedy": "Consumers should stop using the recalled pressure washers immediately and contact AZ Home Concept for a full refund. Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed power washer to pressurewasherrecall@outlook.com. Consumers should then dispose of the destroyed recalled product. Refund", "retailers": ["Online at Amazon.com in April 2026 for about $150."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/COMMOWNER-Pressure-Washers-Recalled-Due-to-Serious-Risk-of-Injury-or-Death-from-Shock-and-Electrocution-Hazards-Imported-by-AZ-Home-Concept", "url": "https://recallledger.net/recalls/product-26692-commowner-pressure-washers-recalled-due-to-serious-risk-of-injury-or-d/"}, {"id": "cpsc-26691", "source": "CPSC", "category": "consumer-product", "recall_number": "26691", "title": "Deli Jerry Fuel Containers Recalled Due to Risk of Serious Injury or Death from Burn Hazard and Child Poisoning; Violate Mandatory Standard for Portable Fuel Containers; Sold on Walmart.com by Deli OfficeSupplies", "product": "Deli Jerry Fuel Containers", "reason": "The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not child-resistant, posing a risk of burns and poisoning to children.", "hazard_level": null, "company": "Ningbo DELI IMP. & EXP. Co., Ltd., dba Deli OfficeSupplies, of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Walmart.com from April 2025 through June 2026 for about $36.", "states": [], "nationwide": true, "quantity": "About 1,750", "codes": "", "remedy": "Consumers should stop using the recalled fuel containers immediately and contact Deli OfficeSupplies for a full refund. Consumers will be asked to destroy the fuel container by writing in permanent maker \"RECALLED\" on the product and to send a photo of the destroyed fuel container to service@steelitetool.com. Consumers should then dispose of the recalled product in accordance with local and/or state disposal procedures. Refund", "retailers": ["Online at Walmart.com from April 2025 through June 2026 for about $36."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Deli-Jerry-Fuel-Containers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Burn-Hazard-and-Child-Poisoning-Violate-Mandatory-Standard-for-Portable-Fuel-Containers-Sold-on-Walmart-com-by-Deli-OfficeSupplies", "url": "https://recallledger.net/recalls/product-26691-deli-jerry-fuel-containers-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26690", "source": "CPSC", "category": "consumer-product", "recall_number": "26690", "title": "DUMOS Nine-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units", "product": "DUMOS Nine-Drawer Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.", "hazard_level": null, "company": "Jiangsu Jiayubo Furniture Co., Ltd., of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from December 2025 through June 2026 for about $54.", "states": [], "nationwide": true, "quantity": "About 8,981", "codes": "", "remedy": "Consumers should immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access. Consumers should contact DUMOS for a full refund. Consumers will be asked to destroy the dressers by cutting the drawers in half and writing in permanent marker \"RECALLED\", and to send a photo of the destroyed dressers to dumosdresserrecall@dumos.com. Consumers should then dispose of the recalled products. Refund", "retailers": ["Online at Amazon.com from December 2025 through June 2026 for about $54."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/DUMOS-Nine-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Clothing-Storage-Units", "url": "https://recallledger.net/recalls/product-26690-dumos-nine-drawer-dressers-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26689", "source": "CPSC", "category": "consumer-product", "recall_number": "26689", "title": "TooyBing Wooden Bead Stacking Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Small Parts Ban", "product": "TooyBing Wooden Bead Stacking Toys", "reason": "The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a deadly choking hazard to young children.", "hazard_level": null, "company": "Guangzhou Yide Toys Co., Ltd., of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from July 2023 through December 2025 for approximately $10.", "states": [], "nationwide": true, "quantity": "About 21,758", "codes": "", "remedy": "Consumers should stop using the toys immediately, take them away from children, and contact TooyBing for free replacement. Consumers will be asked to destroy the toys by cutting the red and yellow string laces, writing in permanent marker \"RECALLED\" on the top of the wooden pegged stand and send a photo of the destroyed toy to tooybingwoodenbeadrecall@gmail.com. Consumers should then dispose of the destroyed product. Compliant replacement toys will not be available until October, and consumers will be asked to register for the replacement. TooyBing with contact registered consumers when it is available. Replace", "retailers": ["Online at Amazon.com from July 2023 through December 2025 for approximately $10."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/TooyBing-Wooden-Bead-Stacking-Toys-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Choking-Violate-Small-Parts-Ban", "url": "https://recallledger.net/recalls/product-26689-tooybing-wooden-bead-stacking-toys-recalled-due-to-risk-of-serious-inj/"}, {"id": "cpsc-26688", "source": "CPSC", "category": "consumer-product", "recall_number": "26688", "title": "Taleco Gear Recalls Baby Jumpers, Baby Swings and 2-in-1 Baby Jumper & Swings Due to Risk of Serious Injury or Death from Fall and Strangulation Hazards", "product": "G Taleco Gear Baby Jumpers, Baby Swings and 2-in-1 Baby Jumper & Swings", "reason": "The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging restraint straps and seat openings can pose strangulation hazards.", "hazard_level": null, "company": "Taleco Gear, of La Verne, California", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com, Walmart.com and TalecoGear.com from April 2021 through July 2026 for between $65 and $120.", "states": [], "nationwide": true, "quantity": "About 41,100 (In addition, 150 were sold in Canada)", "codes": "", "remedy": "Consumers should stop using the recalled products immediately and contact Taleco Gear to receive a full refund. Consumers will be provided with instructions on how to destroy the recalled products and provide photos of the destroyed parts to obtain a full refund. Refund", "retailers": ["Online at Amazon.com, Walmart.com and TalecoGear.com from April 2021 through July 2026 for between $65 and $120."], "injuries": "Taleco Gear has received at least 52 reports of fall, impact and strangulation hazards, including at least 32 reports of injuries such as head bumps and a bloody nose.", "source_url": "https://www.cpsc.gov/Recalls/2026/Taleco-Gear-Recalls-Baby-Jumpers-Baby-Swings-and-2-in-1-Baby-Jumper-Swings-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-and-Strangulation-Hazards", "url": "https://recallledger.net/recalls/product-26688-taleco-gear-recalls-baby-jumpers-baby-swings-and-2-in-1-baby-jumper/"}, {"id": "cpsc-26687", "source": "CPSC", "category": "consumer-product", "recall_number": "26687", "title": "Southern Telecom Recalls Brookstone-Branded Tabletop Fire Pits Due to Risk of Serious Burn Injury or Death from Flame Jetting and Fire Hazards", "product": "Brookstone-branded Tabletop Fire Pits", "reason": "Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as flame jetting from fuel containers, resulting in serious or fatal burns.", "hazard_level": null, "company": "Southern Telecom Inc., of Brooklyn, New York", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Macy's, Marshalls, T.J. Maxx, Indoff, iBuy, and Newton Buying Corp. stores nationwide and online at Macys.com and other websites from February 2023 through December 2024 for between $20 and $25.", "states": [], "nationwide": true, "quantity": "About 48,700", "codes": "UPCs: 680079015930, 680079015947, 680079015954", "remedy": "Consumers should stop using the Brookstone-branded Tabletop Fire Pits immediately and contact Southern Telecom to receive a full refund. Consumers can email a photo of the fire pit with \"Recalled,\" their name, and the date written on it in permanent marker to support@customersupport123.com and then dispose of the product. Do not sell or give away these hazardous products. Refund", "retailers": ["Macy's, Marshalls, T.J. Maxx, Indoff, iBuy, and Newton Buying Corp. stores nationwide and online at Macys.com and other websites from February 2023 through December 2024 for between $20 and $25."], "injuries": "Southern Telecom has received two reports of flame jetting and flames escaping from the concrete container, resulting in two injuries including second-degree and third-degree burns.", "source_url": "https://www.cpsc.gov/Recalls/2026/Southern-Telecom-Recalls-Brookstone-Branded-Tabletop-Fire-Pits-Due-to-Risk-of-Serious-Burn-Injury-or-Death-from-Flame-Jetting-and-Fire-Hazards", "url": "https://recallledger.net/recalls/product-26687-southern-telecom-recalls-brookstone-branded-tabletop-fire-pits-due-to/"}, {"id": "cpsc-26686", "source": "CPSC", "category": "consumer-product", "recall_number": "26686", "title": "Goody King Magnetic Building Cubes and Blocks Recalled Due to Risk of Serious Injury or Death from Magnetic Ingestion Hazard; Imported by Yi Suen Commerce", "product": "Goody King Magnetic Building Cubes and Blocks", "reason": "The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.", "hazard_level": null, "company": "Yi Suen Commerce, of Hong Kong", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from January 2024 through July 2026 for between $17 and $50.", "states": [], "nationwide": true, "quantity": "About 213,500", "codes": "", "remedy": "Consumers should stop using the recalled magnetic building cubes immediately and contact Yi Suen Commerce for a full refund. Consumers will be provided with a pre-paid label to return the recalled magnetic cubes to receive a refund. Refund", "retailers": ["Online at Amazon.com from January 2024 through July 2026 for between $17 and $50."], "injuries": "Yi Suen Commerce is aware of two children who have ingested magnets from the cubes and required surgery to remove the magnets. Yi Suen Commerce is also aware of least 27 reports of the cubes breaking or opening, causing the magnets to become loose and accessible to children.", "source_url": "https://www.cpsc.gov/Recalls/2026/Goody-King-Magnetic-Building-Cubes-and-Blocks-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnetic-Ingestion-Hazard-Imported-by-Yi-Suen-Commerce", "url": "https://recallledger.net/recalls/product-26686-goody-king-magnetic-building-cubes-and-blocks-recalled-due-to-risk-of/"}, {"id": "cpsc-26685", "source": "CPSC", "category": "consumer-product", "recall_number": "26685", "title": "Cooluli Recalls 10-Liter and 15-Liter Minifridges Due to Fire and Burn Hazards", "product": "Cooluli Minifridges, 10-Liter and 15-Liter models", "reason": "The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.", "hazard_level": null, "company": "Ningbo Iceberg Electronic Appliance Co., Ltd., of China", "company_location": "China", "date": "2026-08-13", "report_date": "2026-08-14", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com and Cooluli.com from January 2019 through October 2024 for between $80 and $120.", "states": [], "nationwide": true, "quantity": "About 250,000", "codes": "", "remedy": "Consumers should stop using the recalled minifridges immediately and contact Cooluli for a free replacement power cord. Consumers will be asked to visit www.cooluli.com/pages/product-notices-recalls to enter the model and batch numbers to determine whether their minifridge is included in the recall. Consumers who have recalled minifridges will be instructed to unplug the minifridge, cut the power cord and submit photos to Cooluli showing the model and batch numbers of the fridge. Cooluli will provide a replacement DC power cord and permanent sticker to cover the AC port. Replace", "retailers": ["Online at Amazon.com and Cooluli.com from January 2019 through October 2024 for between $80 and $120."], "injuries": "Cooluli has received at least 19 reports of the minifridges smoking, sparking, burning, melting, overheating or catching fire, resulting in property damages totaling more than $80,000. One consumer reported a smoke inhalation injury.", "source_url": "https://www.cpsc.gov/Recalls/2026/Cooluli-Recalls-10-Liter-and-15-Liter-Minifridges-Due-to-Fire-and-Burn-Hazards", "url": "https://recallledger.net/recalls/product-26685-cooluli-recalls-10-liter-and-15-liter-minifridges-due-to-fire-and-burn/"}, {"id": "fda-food-h-1272-2026", "source": "FDA", "category": "food", "recall_number": "H-1272-2026", "title": "Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES recall (Blank Slate Creamery Production)", "product": "Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, 4.5 oz clear plastic package", "reason": "undeclared egg", "hazard_level": "Class I", "company": "Blank Slate Creamery Production", "company_location": "Ann Arbor, MI, United States", "date": "2026-08-01", "report_date": "2026-08-12", "status": "Terminated", "distribution": "Ann Arbor and Brighton, MI at 3 store locations", "states": ["MI"], "nationwide": false, "quantity": "66 individual retail units", "codes": "best by dates 11/23/26 and 1/9/27", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-1272-2026%22", "url": "https://recallledger.net/recalls/food-h-1272-2026-blank-slate-creamery-vegan-non-dairy-frozen-dessert-coconut-fudge-sand/"}, {"id": "fda-drug-d-0745-2026", "source": "FDA", "category": "drug", "recall_number": "D-0745-2026", "title": "Mirabegron Extended-Release Tablets recall (Zydus Pharmaceuticals (USA) Inc)", "product": "Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.", "reason": "CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.", "hazard_level": "Class II", "company": "Zydus Pharmaceuticals (USA) Inc", "company_location": "Pennington, NJ, United States", "date": "2026-08-05", "report_date": "2026-08-12", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "", "codes": "Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0745-2026%22", "url": "https://recallledger.net/recalls/drug-d-0745-2026-mirabegron-extended-release-tablets-25-mg-30-count-bottle-rx-only/"}, {"id": "cpsc-26677", "source": "CPSC", "category": "consumer-product", "recall_number": "26677", "title": "Head Watersports Recalls Apeks Second Stage Scuba Regulators Recalled Due to Risk of Serious Injury or Death from Drowning Hazard", "product": "Apeks Second Stage Scuba Regulators", "reason": "The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk of serious injury or death from a drowning hazard.", "hazard_level": null, "company": "HEAD USA, Inc. dba Head Watersports of Delray Beach, Florida", "company_location": "England", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Authorized Apeks, Aqualung, and HEAD Watersports retailers and online at apeksdiving.com, aqualung.com and head.com from April 2025 through June 2026 for between $260 to $1,140.", "states": [], "nationwide": true, "quantity": "About 1,105", "codes": "", "remedy": "Consumers should stop using the recalled second stage scuba regulators immediately and bring the product to any HEAD Watersports Authorized Retailer who will replace the valve spindle assembly at no cost to the consumer. Repair", "retailers": ["Authorized Apeks, Aqualung, and HEAD Watersports retailers and online at apeksdiving.com, aqualung.com and head.com from April 2025 through June 2026 for between $260 to $1,140."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Head-Watersports-Recalls-Apeks-Second-Stage-Scuba-Regulators-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Drowning-Hazard", "url": "https://recallledger.net/recalls/product-26677-head-watersports-recalls-apeks-second-stage-scuba-regulators-recalled/"}, {"id": "cpsc-26676", "source": "CPSC", "category": "consumer-product", "recall_number": "26676", "title": "Fitueyes Recalls Laziza Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units", "product": "Laziza Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.", "hazard_level": null, "company": "Fitueyes, Inc., of City of Industry, California", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Wayfair.com from March 2024 through April 2026 for about $870.", "states": [], "nationwide": true, "quantity": "About 150", "codes": "", "remedy": "Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access. Contact Fitueyes for a full refund. Consumers will be asked to write the word \"recalled\" on the top and all sides of the dresser with a permanent marker and to submit a photo to lazizadresserrecall@s-homooi.com. Consumers should then dispose of the recalled product. Refund", "retailers": ["Online at Wayfair.com from March 2024 through April 2026 for about $870."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Fitueyes-Recalls-Laziza-Dressers-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Clothing-Storage-Units", "url": "https://recallledger.net/recalls/product-26676-fitueyes-recalls-laziza-dressers-due-to-risk-of-serious-injury-or-deat/"}, {"id": "cpsc-26675", "source": "CPSC", "category": "consumer-product", "recall_number": "26675", "title": "Wichard Groupe North America Recalls Courant Spliced Kalimba Climbing Ropes Due to Risk of Serious Injury or Death from Fall Hazard", "product": "Courant Spliced Kalimba Climbing Ropes", "reason": "The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard.", "hazard_level": null, "company": "Courant, of Angers, France", "company_location": "France", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Vertical Supply Group, Arbsession, RBI Corporation and nationwide retailers from January 2023 through June 2026 for between $250 and $350.", "states": [], "nationwide": true, "quantity": "About 1,050", "codes": "", "remedy": "Consumers should stop using the recalled ropes immediately and contact Wichard Groupe North America for a free replacement rope, including shipping. Consumers will be asked to complete the registration form at https://www.wichardgroupe.us/news/post/recall-spliced-kalimba to receive a pre-paid shipping label and instructions for returning the recalled product. Consumers will be offered one of two free replacement options; one with immediate availability and the other with availability beginning mid-September. Replace", "retailers": ["Vertical Supply Group, Arbsession, RBI Corporation and nationwide retailers from January 2023 through June 2026 for between $250 and $350."], "injuries": "The firm has received three reports of splices failing. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Wichard-Groupe-North-America-Recalls-Courant-Spliced-Kalimba-Climbing-Ropes-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-Hazard", "url": "https://recallledger.net/recalls/product-26675-wichard-groupe-north-america-recalls-courant-spliced-kalimba-climbing/"}, {"id": "cpsc-26674", "source": "CPSC", "category": "consumer-product", "recall_number": "26674", "title": "Vanderhall North America Recalls Brawley GTS Electric Recreational Off Highway Vehicles (ROVs) Due to Risk of Serious Injury or Death from Crash Hazard", "product": "Vanderhall Brawley GTS electric recreational off highway vehicles", "reason": "The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of serious injury or death from a crash hazard.", "hazard_level": null, "company": "Vanderhall North America, LLC, of Provo, Utah", "company_location": "United States", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Vanderhall North America dealers in Utah, Ohio, Michigan, Texas, Montana, North Carolina, Oklahoma, and Arizona, from April 2024 through June 2026 for about $50,000.", "states": [], "nationwide": true, "quantity": "About 210", "codes": "", "remedy": "Consumers should stop using their vehicles immediately and contact Vanderhall North America for instructions on how to update their vehicles to firmware version 7.1.0 through the Vanderhall customer mobile app. The updated software was released on April 15, 2026, and can be identified by Vanderhall logo. Owners requiring assistance updating their firmware should contact their dealer or Vanderhall directly for assistance. Repair", "retailers": ["Vanderhall North America dealers in Utah, Ohio, Michigan, Texas, Montana, North Carolina, Oklahoma, and Arizona, from April 2024 through June 2026 for about $50,000."], "injuries": "The firm has received one report of a vehicle unexpectedly accelerating. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Vanderhall-North-America-Recalls-Brawley-GTS-Electric-Recreational-Off-Highway-Vehicles-ROVs-Due-to-Risk-of-Serious-Injury-or-Death-from-Crash-Hazard", "url": "https://recallledger.net/recalls/product-26674-vanderhall-north-america-recalls-brawley-gts-electric-recreational-off/"}, {"id": "cpsc-26673", "source": "CPSC", "category": "consumer-product", "recall_number": "26673", "title": "KC Imports and Exports Recalls Mini Laser Pointer Keychains Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries", "product": "Laser & LED Light Mini Laser Pointer Keychains", "reason": "The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.", "hazard_level": null, "company": "KC IMPORTS AND EXPORTS, Inc., of Vernon, California", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Gas stations and discount stores nationwide and online at https://www.divaatheartsj.com/from June 2025 through June 2026 for about 42 cents per unit.", "states": [], "nationwide": true, "quantity": "9,600", "codes": "", "remedy": "Consumers should stop using the recalled laser keychains immediately and contact KC Import and Export for refund. To receive a refund, email a photo of the products disposed of in the trash to kcimport90058@hotmail.com. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Gas stations and discount stores nationwide and online at https://www.divaatheartsj.com/from June 2025 through June 2026 for about 42 cents per unit."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/KC-Imports-and-Exports-Recalls-Mini-Laser-Pointer-Keychains-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Consumer-Products-with-Button-Cell-Batteries", "url": "https://recallledger.net/recalls/product-26673-kc-imports-and-exports-recalls-mini-laser-pointer-keychains-due-to-ris/"}, {"id": "cpsc-26672", "source": "CPSC", "category": "consumer-product", "recall_number": "26672", "title": "Syera Projecting Finger Light Toys Recalled Due to Risk of Serious Injury from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on TEMU by Senyu", "product": "Space Astronaut LED Finger Lights", "reason": "The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.", "hazard_level": null, "company": "Senyu Era International Co. Limited, dba Syera, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Temu.com from December 2025 through April 2026 for between $8 and $16.", "states": [], "nationwide": true, "quantity": "About 184", "codes": "", "remedy": "Consumers should stop using the recalled toys immediately, take them away from children and contact Syera for a full refund. Consumers will be asked to remove and properly dispose of the finger lights into the trash and send a photo of the disposed product to syerarecallusa@outlook.com. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Online at Temu.com from December 2025 through April 2026 for between $8 and $16."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Syera-Projecting-Finger-Light-Toys-Recalled-Due-to-Risk-of-Serious-Injury-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Toys-Sold-on-TEMU-by-Senyu", "url": "https://recallledger.net/recalls/product-26672-syera-projecting-finger-light-toys-recalled-due-to-risk-of-serious-inj/"}, {"id": "cpsc-26671", "source": "CPSC", "category": "consumer-product", "recall_number": "26671", "title": "Little Rawr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Okabesini-us", "product": "Little Rawr Silicone Pull String Teething Toys", "reason": "The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and a deadly choking hazard.", "hazard_level": null, "company": "Shenzhen Okabesini Technology Co., Ltd., dba Okabesini-us, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2025 through April 2026 for between $11 to $15.", "states": [], "nationwide": true, "quantity": "About 2,180", "codes": "", "remedy": "Consumers should stop using the teething toy immediately, take it away from children and contact Okabesini-us to receive a full refund. Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker \"RECALLED\" on the main body of the toy and send a photo of the destroyed toy and order number if available to lilrawrrecall@163.com. Consumers should then dispose of the destroyed product. Refund", "retailers": ["Online at Amazon.com from September 2025 through April 2026 for between $11 to $15."], "injuries": "The firm is aware of one report of the toy's strings reaching the back of a child's throat, resulting in respiratory distress or choking.", "source_url": "https://www.cpsc.gov/Recalls/2026/Little-Rawr-Pull-String-Teething-Toys-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Choking-Violate-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-Okabesini-us", "url": "https://recallledger.net/recalls/product-26671-little-rawr-pull-string-teething-toys-recalled-due-to-risk-of-serious/"}, {"id": "cpsc-26670", "source": "CPSC", "category": "consumer-product", "recall_number": "26670", "title": "A2batt Recalls EEMB Lithium Coin Battery Chargers Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries", "product": "EEMB Lithium-ion Coin Battery Chargers with Rechargeable 2032 Batteries", "reason": "The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings, as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.", "hazard_level": null, "company": "EEMB USA, doing business as A2batt, Inc., of Redlands, California", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from August 2024 through March 2026 for about $14.", "states": [], "nationwide": true, "quantity": "About 4,930", "codes": "", "remedy": "Consumers should stop using the charger immediately, remove the batteries and place them in an area that children cannot access. Contact A2batt to receive a full refund. Consumers will be asked to write \"RECALL\" on the charger. If batteries remain in packaging, dispose of the batteries according to local hazardous waste guidelines and provide a photo of the disposal to info@a2batt.com. Note: Button cell and coin batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Online at Amazon.com from August 2024 through March 2026 for about $14."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/A2batt-Recalls-EEMB-Lithium-Coin-Battery-Chargers-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Consumer-Products-with-Coin-Batteries", "url": "https://recallledger.net/recalls/product-26670-a2batt-recalls-eemb-lithium-coin-battery-chargers-due-to-risk-of-serio/"}, {"id": "cpsc-26669", "source": "CPSC", "category": "consumer-product", "recall_number": "26669", "title": "Play Yard and Crib Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment and Fire Hazards; Violate Mandatory Standards for Mattresses; Sold on Amazon by Voomf", "product": "Voomf Play Yard and Crib Mattresses", "reason": "The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain play yards, posing a deadly entrapment hazard. Babies can suffocate in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant from breathing. Furthermore, the full-sized crib mattresses violate the mandatory flammability standard for mattress sets, posing a risk of serious injury or death from fire.", "hazard_level": null, "company": "Shanghaiyuejiuyaoguojimaoyiyouxiangongsi (Shanghai Yuejiuyao International Trade Co., Ltd.), dba Voomf, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from January 2026 through May 2026 for between $40 and $87.", "states": [], "nationwide": true, "quantity": "About 2,401", "codes": "", "remedy": "Consumers should stop using the mattresses immediately and contact Voomf for a full refund. Consumers will be asked to destroy the mattresses by writing in permanent marker \"Recalled,\" cutting the play yard mattress in half and cutting the full-sized mattress cover diagonally across the entire mattress using scissors, and to send a photo of the destroyed mattress to voomfrecall@outlook.com. Consumers should then dispose of the recalled product in accordance with local and/or state disposal procedures. Refund", "retailers": ["Online at Amazon.com from January 2026 through May 2026 for between $40 and $87."], "injuries": "CPSC has received one report of inadequate mattress fit. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Play-Yard-and-Crib-Mattresses-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Entrapment-and-Fire-Hazards-Violate-Mandatory-Standards-for-Mattresses-Sold-on-Amazon-by-Voomf", "url": "https://recallledger.net/recalls/product-26669-play-yard-and-crib-mattresses-recalled-due-to-risk-of-serious-injury-o/"}, {"id": "cpsc-26668", "source": "CPSC", "category": "consumer-product", "recall_number": "26668", "title": "Liuqibax Adult Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Luqiba", "product": "Liuqibax Adult Bed Rails", "reason": "The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.", "hazard_level": null, "company": "Changsha 678 Trading Co., Ltd., dba Luqiba, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from July 2024 through May 2026 for about $60.", "states": [], "nationwide": true, "quantity": "About 12,000", "codes": "", "remedy": "Consumers should stop using the recalled bed rails immediately and contact Luqiba for a full refund. Consumers will be asked to destroy the bed rails by dismantling them, cutting off the safety strap and storage bag and writing in permanent marker \"RECALLED\" on the upper and lower rails, and email a photo of the destroyed rails to Liuqibax@outlook.com. Consumers should then dispose of the destroyed product. Refund", "retailers": ["Online at Amazon.com from July 2024 through May 2026 for about $60."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Liuqibax-Adult-Bed-Rails-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Entrapment-and-Asphyxiation-Violate-Mandatory-Standard-for-Adult-Portable-Bed-Rails-Sold-on-Amazon-by-Luqiba", "url": "https://recallledger.net/recalls/product-26668-liuqibax-adult-bed-rails-recalled-due-to-risk-of-serious-injury-or-dea/"}, {"id": "cpsc-26667", "source": "CPSC", "category": "consumer-product", "recall_number": "26667", "title": "Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by PIXLABBY", "product": "PIXLABBY Silicone Sensory Magnetic Fidget Sliders", "reason": "The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.", "hazard_level": null, "company": "Huoshan County Haozhou E-commerce Co, doing business as PIXLABBY, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from October 2025 through May 2026 for about $10.", "states": [], "nationwide": true, "quantity": "860", "codes": "", "remedy": "Consumers should take the fidget sliders away from children, stop using them immediately and contact PIXLABBY for a full refund. Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to ah1998zxc@gmail.com to receive a refund. Refund", "retailers": ["Online at Amazon.com from October 2025 through May 2026 for about $10."], "injuries": "CPSC and the firm are aware of a report involving a child who removed the silicone casing, accessed the two small magnets inside the slider and ingested them. The child was hospitalized.", "source_url": "https://www.cpsc.gov/Recalls/2026/Magnetic-Fidget-Sliders-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnet-Ingestion-Violate-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-PIXLABBY", "url": "https://recallledger.net/recalls/product-26667-magnetic-fidget-sliders-recalled-due-to-risk-of-serious-injury-or-deat/"}, {"id": "cpsc-26665", "source": "CPSC", "category": "consumer-product", "recall_number": "26665", "title": "Wnttmt Baby Walkers Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violate Mandatory Standard for Infant Walkers; Sold on Amazon by WURUI.BABY", "product": "Wnttmt Baby Walkers", "reason": "The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant walkers have leg openings that allow the child to slip down until the child's head can become entrapped, posing a risk of serious injury or death.", "hazard_level": null, "company": "Changsha Yuelu District Ruiwu E-Commerce Co., Ltd., dba WURUI.BABY, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from February 2026 through March 2026 for between $65 and $75.", "states": [], "nationwide": true, "quantity": "About 1,310", "codes": "", "remedy": "Consumers should stop using the recalled infant walkers immediately and contact WURUI.BABY for a full refund. Consumers will be asked to disassemble the walker, cut the fabric seat, write \"Recalled\" on the top of the tray in permanent marker and send a photo of the recalled infant walker to wbabywalker-recall@outlook.com. Refund", "retailers": ["Online at Amazon.com from February 2026 through March 2026 for between $65 and $75."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Wnttmt-Baby-Walkers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Infant-Walkers-Sold-on-Amazon-by-WURUI-BABY", "url": "https://recallledger.net/recalls/product-26665-wnttmt-baby-walkers-recalled-due-to-risk-of-serious-injury-or-death-fr/"}, {"id": "cpsc-26664", "source": "CPSC", "category": "consumer-product", "recall_number": "26664", "title": "Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys: Sold on Amazon by BUSOHA", "product": "BUSOHA Magnetic Fidget Slider Toys", "reason": "The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.", "hazard_level": null, "company": "Shenzhen Yuejia Mei Maoyi Youxian Gongsi (Shenzhen Yuejia Mei Trading Co., Ltd.), doing business as BUSOHA, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from December 2025 through May 2026 for about $7.", "states": [], "nationwide": true, "quantity": "About 2,186", "codes": "", "remedy": "Consumers should take the fidget sliders away from children, stop using them immediately and contact BUSOHA for a full refund. Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to BUSHOHArecall@outlook.com to receive a refund. Refund", "retailers": ["Online at Amazon.com from December 2025 through May 2026 for about $7."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Magnetic-Fidget-Sliders-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnet-Ingestion-Violate-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-BUSOHA", "url": "https://recallledger.net/recalls/product-26664-magnetic-fidget-sliders-recalled-due-to-risk-of-serious-injury-or-deat/"}, {"id": "cpsc-26663", "source": "CPSC", "category": "consumer-product", "recall_number": "26663", "title": "Winston Porter and Seeday 3-Drawer, 4-Drawer, and 5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units", "product": "Winston Porter and Seeday 3-Drawer, 4-Drawer and 5-Drawer Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.", "hazard_level": null, "company": "Linyi Lingmoxuan Technology Co., Ltd., of China and Shenzhen Xinmu Home Furnishing Trading Co., Ltd., dba Seeday, of China", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at The 3-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $110. The 4-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $130. The 5-Drawer Dresser was sold on Wayfair.com and Amazon.com from May 2025 through January 2026 for between $70 and $160.", "states": [], "nationwide": true, "quantity": "About 2,000 5-Drawer Dressers, 28 3-Drawer Dressers and 22 4-Drawer Dressers", "codes": "", "remedy": "Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access. Consumers should contact Linyi Lingmoxuan and Seeday for instructions on how to identify affected units and dispose of the dressers to receive a full refund. Consumers will be asked to write the word \"recalled\" on the top and all sides of the dresser with a permanent marker and email a photo demonstrating disposal of the product to Winstonporterseedayrecall@outlook.com. Refund", "retailers": ["The 3-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $110. The 4-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $130. The 5-Drawer Dresser was sold on Wayfair.com and Amazon.com from May 2025 through January 2026 for between $70 and $160."], "injuries": "One report of a tip-over incident with a dresser that resulted in the injury of a 3-year-old child.", "source_url": "https://www.cpsc.gov/Recalls/2026/Winston-Porter-and-Seeday-3-Drawer-4-Drawer-and-5-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Clothing-Storage-Units", "url": "https://recallledger.net/recalls/product-26663-winston-porter-and-seeday-3-drawer-4-drawer-and-5-drawer-dressers-re/"}, {"id": "cpsc-26662", "source": "CPSC", "category": "consumer-product", "recall_number": "26662", "title": "OKK Trading Recalls Easter LED Headbands Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys", "product": "Easter LED Headbands", "reason": "The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.", "hazard_level": null, "company": "OKK Trading, Inc., of Vernon, California", "company_location": "China", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Retail dollar stores and gift stores mostly in California, Texas and Arizona from November 2023 through April 2026 for between $1 and $2.", "states": [], "nationwide": true, "quantity": "About 25,200", "codes": "", "remedy": "Consumers should stop using the Easter LED Headbands immediately and contact OKK Trading for a refund. Consumers will be asked to email recall@okktoys.com a photograph showing the product being properly disposed of in the trash. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Refund", "retailers": ["Retail dollar stores and gift stores mostly in California, Texas and Arizona from November 2023 through April 2026 for between $1 and $2."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/OKK-Trading-Recalls-Easter-LED-Headbands-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violate-Mandatory-Standard-for-Toys", "url": "https://recallledger.net/recalls/product-26662-okk-trading-recalls-easter-led-headbands-due-to-risk-of-serious-injury/"}, {"id": "cpsc-26661", "source": "CPSC", "category": "consumer-product", "recall_number": "26661", "title": "Louisville Ladder Recalls Over One Million Attic Stairway Ladders Due to Risk of Serious Injury or Death from Fall Hazard", "product": "Louisville, Featherlite, Lite & Century Attic Stairway Ladders with gas struts", "reason": "The bolts on the attic stairway ladders can break while in use, posing a risk of serious injury or death from fall hazard.", "hazard_level": null, "company": "Louisville Ladder, Inc., of Louisville, Kentucky", "company_location": "Mexico", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at The Home Depot, Lowe's, Do It Best, Orgill, and other retailers nationwide and on-line at Amazon.com from November 2012 through July 2026 for between $170 and $600.", "states": [], "nationwide": true, "quantity": "1,770,000 (In addition, about 13,054 were sold in Canada)", "codes": "", "remedy": "Consumers should stop using the recalled ladders immediately and register at Atticstairwayrecall.expertinquiry.com to receive a free repair kit. Consumers should have the ladder's model number, which can be found on the inside of the attic door, available when they register. If your unit is included in the recall, the firm will send a free repair kit containing two replacement ¼\" spreader bolts, washers, and lock nuts with installation instructions. Repair", "retailers": ["The Home Depot, Lowe's, Do It Best, Orgill, and other retailers nationwide and on-line at Amazon.com from November 2012 through July 2026 for between $170 and $600."], "injuries": "The firm has received 11 reports of a bolt breaking, including one report of an injury to the neck, head and back.", "source_url": "https://www.cpsc.gov/Recalls/2026/Louisville-Ladder-Recalls-Over-One-Million-Attic-Stairway-Ladders-Due-to-Risk-of-Serious-Injury-or-Death-from-Fall-Hazard", "url": "https://recallledger.net/recalls/product-26661-louisville-ladder-recalls-over-one-million-attic-stairway-ladders-due/"}, {"id": "cpsc-26648", "source": "CPSC", "category": "consumer-product", "recall_number": "26648", "title": "DR Power Equipment Recalls Lawn Mowers Due to Risk of Serious Injury or Death from Laceration Hazard; Violate Mandatory Standard for Lawn Mowers", "product": "DR Power PRO MAX30 30\" Walk-Behind Power Lawn Mowers", "reason": "The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blade control system engaged or continue to operate even after the release of the control, posing a serious laceration hazard.", "hazard_level": null, "company": "Generac Power Systems Inc., of Waukesha, Wisconsin", "company_location": "United States", "date": "2026-08-06", "report_date": "2026-08-07", "status": "Announced", "distribution": "Sold in the United States at Independent power equipment stores nationwide and online at drpower.com from September 2024 through September 2025 for between $1,600 and $1,800.", "states": [], "nationwide": true, "quantity": "About 320 (In addition, 9 were sold in Canada)", "codes": "", "remedy": "Consumers should stop using the recalled mowers immediately unless they have already received a free repair kit in the mail from DR Power and it has been installed. If the repair kit has not been installed, contact DR Power to receive updated repair instructions or schedule a free repair from an authorized dealer. Owners who have not received a repair kit should contact DR Power Equipment to receive a free repair kit or schedule a free repair from an authorized dealer. Repair", "retailers": ["Independent power equipment stores nationwide and online at drpower.com from September 2024 through September 2025 for between $1,600 and $1,800."], "injuries": "The manufacturer reported 19 incidents involving the mower blades staying engaged or not stopping after release of the blade control. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/DR-Power-Equipment-Recalls-Lawn-Mowers-Due-to-Risk-of-Serious-Injury-or-Death-from-Laceration-Hazard-Violate-Mandatory-Standard-for-Lawn-Mowers", "url": "https://recallledger.net/recalls/product-26648-dr-power-equipment-recalls-lawn-mowers-due-to-risk-of-serious-injury-o/"}]}