{"month": "2025-12", "count": 421, "recalls": [{"id": "fda-device-z-2356-2026", "source": "FDA", "category": "device", "recall_number": "Z-2356-2026", "title": "NexxZr T Multi A3.5 W98-16mm recall (Sagemax Bioceramics, Inc.)", "product": "NexxZr T Multi A3.5 W98-16mm, REF: 745451", "reason": "Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have  reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.", "hazard_level": "Class II", "company": "Sagemax Bioceramics, Inc.", "company_location": "Federal Way, WA, United States", "date": "2025-12-11", "report_date": "2026-06-17", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.", "states": ["CA", "FL", "ID", "MN", "MO", "NY"], "nationwide": true, "quantity": "113", "codes": "UDI-DI: 00842271175373, Lot: YBDGLD", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2356-2026%22", "url": "https://recallledger.net/recalls/device-z-2356-2026-nexxzr-t-multi-a3-5-w98-16mm-ref-745451/"}, {"id": "fda-food-h-0900-2026", "source": "FDA", "category": "food", "recall_number": "H-0900-2026", "title": "Betaine Anhydrous recall (Creative Compounds, LLC)", "product": "Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as \"***BETAINE ANHYDROUS 98%***Distributed by Creative Compounds, LLC Scott City, Missouri USA 63780***\"", "reason": "Possible carbon steel foreign material (1-2mm)", "hazard_level": "Class II", "company": "Creative Compounds, LLC", "company_location": "Scott City, MO, United States", "date": "2025-12-15", "report_date": "2026-06-10", "status": "Terminated", "distribution": "5 direct accounts located in FL, NJ, TX, GA and OR", "states": ["FL", "GA", "NJ", "OR", "TX"], "nationwide": false, "quantity": "2055 kgs", "codes": "Lot Code SWT2025100101 Expiration Date September 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0900-2026%22", "url": "https://recallledger.net/recalls/food-h-0900-2026-betaine-anhydrous-2055kg-material-packed-in-foil-bags-inside-15kg-ca/"}, {"id": "fda-device-z-2295-2026", "source": "FDA", "category": "device", "recall_number": "Z-2295-2026", "title": "Phothera 200 recall (Daavlin Distributing Company)", "product": "Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4", "reason": "Some of the Calibration/Output Certificates had the outputs reversed.", "hazard_level": "Class II", "company": "Daavlin Distributing Company", "company_location": "Bryan, OH, United States", "date": "2025-12-10", "report_date": "2026-06-10", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "368 units", "codes": "Serial Numbers: 2-03409NB4DT 2-03560NB4DT 2-03798NB4DT 2-03472NB4DT 2-03315NB4DT 2-03726NB4DT 2-03396NB4DT 2-03320NB4DT 2-03447NB4DT 2-03564NB4DT 2-03516NB4DT 2-03467NB4DT 2-03292NB4DT 2-03371NB4DT 2-03433NB4DT 2-03446NB4DT 2-03343NB4DT 2-03400NB4DT 2-03342NB4DT 2-03547NB4DT 2-03449NB4DT 2-03685NB4DT 2-03574NB4DT 2-03392NB4DT 2-03345NB4DT 2-03431NB4DT 2-03608NB4DT 2-03530NB4DT 2-03501NB4DT 2-03362NB4DT 2-03603NB4DT 2-03713NB4DT 2-03508NB4DT 2-03341NB4DT 2-03418NB4DT 2-03721NB4DT 2-03662NB4DT 2-03679NB4DT 2-03591NB4DT 2-03319NB4DT 2-03411NB4DT 2-03505NB4DT 2-03335NB4DT 2-03585NB4DT 2-03556NB4DT 2-03355NB4DT 2-03664NB4DT 2-03515NB4DT 2-03424NB4DT 2-03470NB4DT 2-03386NB4DT 2-03455NB4DT 2-03401NB4DT 2-03391NB4DT 2-03578NB4DT 2-03388NB4DT 2-03632NB4DT 2-03615NB4DT 2-03434NB4DT 2-03454NB4DT 2-03387NB4DT 2-03390NB4DT 2-03569NB4DT 2-03541NB4DT 2-03509NB4DT 2-03789NB4DT 2-03804NB4DT 2-03439NB4DT 2-03367NB4DT 2-03442NB4DT 2-03750NB4DT 2-03349NB4DT 2-03510NB4DT 2-03538NB4DT 2-03559NB4DT 2-03539NB4DT 2-03491NB4DT 2-03502NB4DT 2-03629NB4DT 2-03383NB4DT 2-03496NB4DT 2-03619NB4DT 2-03511NB4DT 2-03670NB4DT 2-03565NB4DT 2-03581NB4DT 2-03479NB4DT 2-03348NB4DT 2-03534NB4DT 2-03484NB4DT 2-03802NB4DT 2-03504NB4DT 2-03457NB4DT 2-03417NB4DT 2-03482NB4DT 2-03318NB4DT 2-03503NB4DT 2-03518NB4DT 2-03350NB4DT 2-03686NB4DT 2-03317NB4DT 2-03687NB4DT 2-03507NB4DT 2-03663NB4DT 2-03658NB4DT 2-03330NB4DT 2-03489NB4DT 2-03451NB4DT 2-03486NB4DT 2-03465NB4DT 2-03346NB4DT 2-03598NB4DT 2-03377NB4DT 2-03414NB4DT 2-03422NB4DT 2-03531NB4DT 2-03329NB4DT 2-03579NB4DT 2-03817NB4DT 2-03613NB4DT 2-03322NB4DT 2-03570NB4DT 2-03397NB4DT 2-03326NB4DT 2-03347NB4DT 2-03469NB4DT 2-03483NB4DT 2-03359NB4DT 2-03344NB4DT 2-03436NB4DT 2-03711NB4DT 2-03437NB4DT 2-03459NB4DT 2-03384NB4DT 2-03389NB4DT 2-03592NB4DT 2-03432NB4DT 2-03823NB4DT 2-03616NB4DT 2-03498NB4DT 2-03512NB4DT 2-03809NB4DT 2-03647NB4DT 2-03606NB4DT 2-03722NB4DT 2-03818NB4DT 2-03589NB4DT 2-03356NB4DT 2-03583NB4DT 2-03799NB4DT 2-03487NB4DT 2-03398NB4DT 2-03775NB4DT 2-03427NB4DT 2-03533NB4DT 2-03676NB4DT 2-03468NB4DT 2-03684NB4DT 2-03413NB4DT 2-03716NB4DT 2-03374NB4DT 2-03430NB4DT 2-03473NB4DT 2-03575NB4DT 2-03339NB4DT 2-03666NB4DT 2-03323NB4DT 2-03471NB4DT 2-03334NB4DT 2-03310NB4DT 2-03631NB4DT 2-03405NB4DT 2-03720NB4DT 2-03372NB4DT 2-03463NB4DT 2-03353NB4DT 2-03563NB4DT 2-03419NB4DT 2-03725NB4DT 2-03621NB4DT 2-03336NB4DT 2-03312NB4DT 2-03806NB4DT 2-03572NB4DT 2-03597NB4DT 2-03370NB4DT 2-03435NB4DT 2-03354NB4DT 2-03555NB4DT 2-03440NB4DT 2-03376NB4DT 2-03610NB4DT 2-03653NB4DT 2-03749NB4DT 2-03380NB4DT 2-03558NB4DT 2-03462NB4DT 2-03313NB4DT 2-03517NB4DT 2-03790NB4DT 2-03513NB4DT 2-03602NB4DT 2-03683NB4DT 2-03561NB4DT 2-03514NB4DT 2-03604NB4DT 2-03445NB4DT 2-03423NB4DT 2-03338NB4DT 2-03375NB4DT 2-03361NB4DT 2-03543NB4DT 2-03492NB4DT 2-03801NB4DT 2-03497NB4DT 2-03601NB4DT 2-03824NB4DT 2-03477NB4DT 2-03545NB4DT 2-03813NB4DT 2-03557NB4DT 2-03426NB4DT 2-03428NB4DT 2-03394NB4DT 2-03645NB4DT 2-03842NB4DT 2-03528NB4DT 2-03321NB4DT 2-03478NB4DT 2-03438NB4DT 2-03369NB4DT 2-03661NB4DT 2-03682NB4DT 2-03412NB4DT 2-03351NB4DT 2-03673NB4DT 2-03453NB4DT 2-03605NB4DT 2-03461NB4DT 2-03495NB4DT 2-03582NB4DT 2-03540NB4DT 2-03594NB4DT 2-03612NB4DT 2-03810NB4DT 2-03364NB4DT 2-03609NB4DT 2-03672NB4DT 2-03529NB4DT 2-03379NB4DT 2-03554NB4DT 2-03490NB4DT 2-03407NB4DT 2-03586NB4DT 2-03600NB4DT 2-03618NB4DT 2-03421NB4DT 2-03659NB4DT 2-03671NB4DT 2-03448NB4DT 2-03607NB4DT 2-03402NB4DT 2-03485NB4DT 2-03480NB4DT 2-03420NB4DT 2-03328NB4DT 2-03408NB4DT 2-03481NB4DT 2-03625NB4DT 2-03331NB4DT 2-03614NB4DT 2-03646NB4DT 2-03668NB4DT 2-03800NB4DT 2-03499NB4DT 2-03753NB4DT 2-03520NB4DT 2-03464NB4DT 2-03316NB4DT 2-03580NB4DT 2-03675NB4DT 2-03665NB4DT 2-03546NB4DT 2-03590NB4DT 2-03544NB4DT 2-03415NB4DT 2-03719NB4DT 2-03456NB4DT 2-03532NB4DT 2-03385NB4DT 2-03452NB4DT 2-03593NB4DT 2-03366NB4DT 2-03759NB4DT 2-03506NB4DT 2-03425NB4DT 2-03660NB4DT 2-03360NB4DT 2-03519NB4DT 2-03688NB4DT 2-03537NB4DT 2-03429NB4DT 2-03406NB4DT 2-03340NB4DT 2-03311NB4DT 2-03562NB4DT 2-03474NB4DT 2-03655NB4DT 2-03466NB4DT 2-03595NB4DT 2-03476NB4DT 2-03403NB4DT 2-03752NB4DT 2-03332NB4DT 2-03314NB4DT 2-03309NB4DT 2-03678NB4DT 2-03410NB4DT 2-03460NB4DT 2-03717NB4DT 2-03521NB4DT 2-03674NB4DT 2-03363NB4DT 2-03667NB4DT 2-03475NB4DT 2-03724NB4DT 2-03493NB4DT 2-03617NB4DT 2-03680NB4DT 2-03494NB4DT 2-03450NB4DT 2-03754NB4DT 2-03378NB4DT 2-03712NB4DT 2-03840NB4DT 2-03441NB4DT 2-03416NB4DT 2-03393NB4DT 2-03577NB4DT 2-03751NB4DT 2-03681NB4DT 2-03368NB4DT 2-03333NB4DT 2-03640NB4DT 2-03373NB4DT 2-03358NB4DT 2-03500NB4DT 2-03596NB4DT 2-03811NB4DT 2-03308NB4DT 2-03669NB4DT 2-03337NB4DT 2-03381NB4DT 2-03352NB4DT 2-03488NB4DT 2-03382NB4DT 2-03443NB4DT 2-03357NB4DT 2-03444NB4DT 2-03542NB4DT 2-03599NB4DT 2-03404NB4DT 2-03395NB4DT 2-03365NB4DT 2-03399NB4DT 2-03576NB4DT 2-03458NB4DT 2-03611NB4DT", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2295-2026%22", "url": "https://recallledger.net/recalls/device-z-2295-2026-phothera-200-phototherapy-devices-indicated-for-use-to-treat-diagnose/"}, {"id": "fda-drug-d-0524-2026", "source": "FDA", "category": "drug", "recall_number": "D-0524-2026", "title": "TPN bag recall (Central Admixture Pharmacy Services, Inc (CAPS)  Los Angeles)", "product": "TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670", "reason": "Incorrect Product Formulation: product did not contain insulin as listed in the label.", "hazard_level": "Class II", "company": "Central Admixture Pharmacy Services, Inc (CAPS)  Los Angeles", "company_location": "Santa Fe Springs, CA, United States", "date": "2025-12-27", "report_date": "2026-05-13", "status": "Ongoing", "distribution": "CA", "states": ["CA"], "nationwide": false, "quantity": "1 bag", "codes": "Lot #: 11-4909703-0-1, Exp 12/28/2025", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0524-2026%22", "url": "https://recallledger.net/recalls/drug-d-0524-2026-tpn-bag-patient-specific-rx-11-4909703-0-1-compound-volume-1660-m/"}, {"id": "fda-device-z-1827-2026", "source": "FDA", "category": "device", "recall_number": "Z-1827-2026", "title": "WHILL Model F recall (WHILL, INC.)", "product": "WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel   drive) powered wheelchair.", "reason": "Cyber vulnerability of BLE communication was found by CISA VDP program.", "hazard_level": "Class I", "company": "WHILL, INC.", "company_location": "Shinagawa, Japan", "date": "2025-12-29", "report_date": "2026-05-06", "status": "Ongoing", "distribution": "US: Kansas", "states": ["KS"], "nationwide": false, "quantity": "2324 units", "codes": "UDI/DI 04570072300019, Serial Numbers:  FB1203U2610192, FB1203U2610191, FB1203U2610190, FB1203U2610189, FB1203U2610188, FB1203U2610187, FB1203U2610186, FB1203U2610185, FB1203U2610184, FB1203U2610183, FB1203U2610182, FB1203U2610181, FB1203U2610180, FB1203U2610179, FB1203U2610178, FB1203U2610177, FB1203U2610176, FB1203U2610175, FB1203U2610174, FB1203U2610173, FB1203U2610172, FB1203U2610171, FB1203U2610170, FB1203U2610169, FB1203U2610168, FB1203U2610167, FB1203U2610166, FB1203U2610165, FB1203U2610164, FB1203U2610163, FB1203U2610162, FB1203U2610161, FB1203U2610160, FB1203U2610159, FB1203U2610158, FB1203U2610157, FB1203U2610156, FB1203U2610155, FB1203U2610154, FB1203U2610153, FB1203U2610152, FB1203U2610151, FB1203U2610150, FB1203U2610149, 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"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1827-2026%22", "url": "https://recallledger.net/recalls/device-z-1827-2026-whill-model-f-with-software-versions-before-hmi-2-23-mc-1-05-the/"}, {"id": "fda-device-z-1826-2026", "source": "FDA", "category": "device", "recall_number": "Z-1826-2026", "title": "WHILL Model C2 recall (WHILL, INC.)", "product": "WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.", "reason": "Cyber vulnerability of BLE communication was found by CISA VDP program.", "hazard_level": "Class I", "company": "WHILL, INC.", "company_location": "Shinagawa, Japan", "date": "2025-12-29", "report_date": "2026-05-06", "status": "Ongoing", "distribution": "US: Kansas", "states": ["KS"], "nationwide": false, "quantity": "4685 units", "codes": "UDI/DI 04570072300019, Serial Numbers:  CB2307U25A0134, CB2307U25A0133, CB2307U25A0132, 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CB2107U2570021, CB2107U2570020, CB2107U2570019, CB2107U2570018, CB2107U2570017, CB2107U2570016, CB2107U2570015, CB2107U2570014, CB2107U2570013, CB2107U2570012, CB2107U2570011, CB2107U2570010, CB2107U2570009, CB2107U2570008, CB2107U2570007, CB2107U2570006, CB2107U2570005, CB2107U2570004, CB2107U2570003, CB2107U2570002, CB2107U2570001, CB2207U2540068, CB2207U2540067, CB2207U2540066, CB2207U2540065, CB2207U2540064, CB2207U2540063, CB2207U2540062, CB2207U2540061, CB2207U2540060, CB2207U2540059, CB2207U2540058, CB2207U2540057, CB2207U2540056, CB2207U2540055, CB2207U2540054, CB2207U2540053, CB2207U2540052, CB2207U2540051, CB2207U2540050, CB2207U2540049, CB2207U2540048, CB2207U2540047, CB2207U2540046, CB2207U2540045, CB2207U2540044, CB2207U2540043, CB2207U2540042, CB2207U2540041, CB2207U2540040, CB2207U2540039, CB2207U2540038, CB2207U2540037, CB2207U2540036, CB2207U2540035, CB2207U2540034, CB2207U2540033, CB2207U2540032, CB2207U2540031, CB2207U2540030, CB2207U2540029, CB2207U2540028, CB2207U2540027, CB2207U2540026, CB2207U2540025, CB2207U2540024, CB2207U2540023, CB2107U2540022, CB2107U2540021, CB2107U2540020, CB2107U2540019, CB2107U2540018, CB2107U2540017, CB2107U2540016, CB2107U2540015, CB2107U2540014, CB2107U2540013, CB2107U2540012, CB2107U2540011, CB2107U2540010, CB2107U2540009, CB2107U2540008, CB2107U2540007, CB2107U2540006, CB2107U2540005, CB2107U2540004, CB2107U2540003, CB2107U2540002, CB2107U2540001, CB2307U2530134, CB2307U2530133, CB2307U2530132, CB2307U2530131, CB2307U2530130, CB2307U2530129, CB2307U2530128, CB2307U2530127, CB2307U2530126, CB2307U2530125, CB2307U2530124, CB2307U2530123, CB2307U2530122, CB2307U2530121, CB2307U2530120, CB2307U2530119, CB2307U2530118, CB2307U2530117, CB2307U2530116, CB2307U2530115, CB2307U2530114, CB2307U2530113, CB2307U2530112, CB2307U2530111, CB2307U2530110, CB2307U2530109, CB2307U2530108, CB2307U2530107, CB2307U2530106, CB2307U2530105, CB2307U2530104, CB2307U2530103, CB2207U2530102, CB2207U2530101, CB2207U2530100, CB2207U2530099, CB2207U2530098, CB2207U2530097, CB2207U2530096, CB2207U2530095, CB2207U2530094, CB2207U2530093, CB2207U2530092, CB2207U2530091, CB2207U2530090, CB2207U2530089, CB2207U2530088, CB2207U2530087, CB2207U2530086, CB2207U2530085, CB2207U2530084, CB2207U2530083, CB2207U2530082, CB2207U2530081, CB2207U2530080, CB2207U2530079, CB2207U2530078, CB2207U2530077, CB2207U2530076, CB2207U2530075, CB2207U2530074, CB2207U2530073, CB2207U2530072, CB2207U2530071, CB2207U2530070, CB2207U2530069, CB2107U2530068, CB2107U2530067, CB2307U2510068, CB2307U2510067, CB2307U2510066, CB2307U2510065, CB2307U2510064, CB2307U2510063, CB2307U2510062, CB2307U2510061, CB2307U2510060, CB2307U2510059, CB2307U2510058, CB2307U2510057, CB2307U2510056, CB2307U2510055, CB2307U2510054, CB2307U2510053, CB2307U2510052, CB2307U2510051, CB2307U2510050, CB2307U2510049, CB2307U2510048, CB2307U2510047, CB2307U2510046, CB2307U2510045, CB2307U2510044, CB2307U2510043, CB2207U2510042, CB2207U2510041, CB2207U2510040, CB2207U2510039, CB2207U2510038, CB2207U2510037, CB2207U2510036, CB2207U2510035, CB2207U2510034, CB2207U2510033, CB2207U2510032, CB2207U2510031, CB2207U2510030, CB2207U2510029, CB2207U2510028, CB2207U2510027, CB2207U2510026, CB2207U2510025, CB2207U2510024, CB2207U2510023, CB2207U2510022, CB2207U2510021, CB2207U2510020, CB2207U2510019, CB2207U2510018, CB2207U2510017, CB2207U2510016, CB2207U2510015, CB2207U2510014, CB2207U2510013, CB2207U2510012, CB2207U2510011, CB2107U2510010, CB2107U2510009, CB2107U2510008, CB2107U2510007, CB2107U2510006, CB2107U2510005, CB2107U2510004, CB2107U2510003, CB2107U2510002, CB2107U2510001, CB2307U24C0202, CB2307U24C0201, CB2307U24C0200, CB2307U24C0199, CB2307U24C0198, CB2307U24C0197, CB2307U24C0196, CB2307U24C0195, CB2307U24C0194, CB2307U24C0193, CB2307U24C0192, CB2307U24C0191, CB2307U24C0190, CB2307U24C0189, CB2307U24C0188, CB2307U24C0187, CB2307U24C0186, CB2307U24C0185, CB2307U24C0184, CB2307U24C0183, CB2307U24C0182, CB2307U24C0181, CB2307U24C0180, CB2307U24C0179, CB2307U24C0178, CB2307U24C0177, CB2207U24C0176, CB2207U24C0175, CB2207U24C0174, CB2207U24C0173, CB2207U24C0172, CB2207U24C0171, CB2207U24C0170, CB2207U24C0169, CB2207U24C0168, CB2207U24C0167, CB2207U24C0166, CB2207U24C0165, CB2207U24C0164, CB2207U24C0163, CB2207U24C0162, CB2207U24C0161, CB2207U24C0160, CB2207U24C0159, CB2207U24C0158, CB2207U24C0157, CB2207U24C0156, CB2207U24C0155, CB2207U24C0154, CB2207U24C0153, CB2207U24C0152, CB2207U24C0151, CB2207U24C0150, CB2207U24C0149, CB2207U24C0148, CB2207U24C0147, CB2207U24C0146, CB2207U24C0145, CB2107U24C0144, CB2107U24C0143, CB2107U24C0142, CB2107U24C0141, CB2107U24C0140, CB2107U24C0139, CB2107U24C0138, CB2107U24C0137, CB2107U24C0136, CB2107U24C0135, CB2307U24C0068, CB2307U24C0067, CB2307U24C0066, CB2307U24C0065, CB2307U24C0064, CB2307U24C0063, CB2307U24C0062, CB2307U24C0061, CB2307U24C0060, CB2307U24C0059, CB2307U24C0058, CB2307U24C0057, CB2307U24C0056, CB2307U24C0055, CB2307U24C0054, CB2307U24C0053, CB2307U24C0052, CB2307U24C0051, CB2207U24C0050, CB2207U24C0049, CB2207U24C0048, CB2207U24C0047, CB2207U24C0046, CB2207U24C0045, CB2207U24C0044, CB2207U24C0043, CB2207U24C0042, CB2207U24C0041, CB2207U24C0040, CB2207U24C0039, CB2207U24C0038, CB2207U24C0037, CB2207U24C0036, CB2207U24C0035, CB2207U24C0034, CB2207U24C0033, CB2207U24C0032, CB2207U24C0031, CB2207U24C0030, CB2207U24C0029, CB2207U24C0028, CB2207U24C0027, CB2207U24C0026, CB2207U24C0025, CB2207U24C0024, CB2207U24C0023, CB2207U24C0022, CB2207U24C0021, CB2207U24C0020, CB2207U24C0019, CB2207U24C0018, CB2207U24C0017, CB2107U24C0016, CB2107U24C0015, CB2107U24C0014, CB2107U24C0013, CB2107U24C0012, CB2107U24C0011, CB2107U24C0010, CB2107U24C0009, CB2107U24C0008, CB2107U24C0007, CB2107U24C0006, CB2107U24C0005, CB2107U24C0004, CB2107U24C0003, CB2107U24C0002, CB2107U24C0001, CB2207U24B0200, CB2207U24B0199, CB2207U24B0198, CB2207U24B0197, CB2207U24B0196, CB2207U24B0195, CB2207U24B0194, CB2207U24B0193, CB2207U24B0192, CB2207U24B0191, CB2207U24B0190, CB2207U24B0189, CB2207U24B0188, CB2207U24B0187, CB2207U24B0186, CB2207U24B0185, CB2207U24B0184, CB2207U24B0183, CB2207U24B0182, CB2207U24B0181, CB2207U24B0180, CB2207U24B0179, CB2207U24B0178, CB2207U24B0177, CB2207U24B0176, CB2207U24B0175, CB2207U24B0174, CB2207U24B0173, CB2207U24B0172, CB2207U24B0171, CB2207U24B0170, CB2207U24B0169, CB2207U24B0168, CB2207U24B0167, CB2207U24B0166, CB2207U24B0165, CB2207U24B0164, CB2207U24B0163, CB2207U24B0162, CB2207U24B0161, CB2207U24B0160, CB2207U24B0159, CB2207U24B0158, CB2207U24B0157, CB2207U24B0156, CB2207U24B0155, CB2207U24B0154, CB2207U24B0153, CB2207U24B0152, CB2207U24B0151, CB2107U24B0150, CB2107U24B0149, CB2107U24B0148, CB2107U24B0147, CB2207U24B0146, CB2107U24B0145, CB2107U24B0144, CB2107U24B0143, CB2107U24B0142, CB2107U24B0141, CB2107U24B0140, CB2107U24B0139, CB2107U24B0138, CB2107U24B0137, CB2107U24B0136, CB2107U24B0135, CB2107U24B0134, CB2107U24B0133, CB2307U24A0200, CB2307U24A0199, CB2307U24A0198, CB2307U24A0197, CB2307U24A0196, CB2307U24A0195, CB2307U24A0194, CB2307U24A0193, CB2307U24A0192, CB2307U24A0191, CB2307U24A0190, CB2307U24A0189, CB2307U24A0188, CB2307U24A0187, CB2307U24A0186, CB2307U24A0185, CB2307U24A0184, CB2307U24A0183, CB2307U24A0182, CB2307U24A0181, CB2307U24A0180, CB2307U24A0179, CB2307U24A0178, CB2307U24A0177, CB2307U24A0176, CB2307U24A0175, CB2307U24A0174, CB2307U24A0173, CB2307U24A0172, CB2307U24A0171, CB2307U24A0170, CB2307U24A0169, CB2307U24A0168, CB2307U24A0167, CB2307U24A0166, CB2307U24A0165, CB2307U24A0164, CB2307U24A0163, CB2307U24A0162, CB2307U24A0161, CB2307U24A0160, CB2307U24A0159, CB2307U24A0158, CB2307U24A0157, CB2307U24A0156, CB2307U24A0155, CB2307U24A0154, CB2307U24A0153, CB2107U24A0152, CB2107U24A0151, CB2107U24A0150, CB2107U24A0149, CB2107U24A0148, CB2107U24A0147, CB2107U24A0146, CB2107U24A0145, CB2107U24A0144, CB2107U24A0143, CB2107U24A0142, CB2107U24A0141, CB2107U24A0140, CB2107U24A0139, CB2107U24A0138, CB2107U24A0137, CB2107U24A0136, CB2107U24A0135, CB2107U24A0134, CB2107U24A0133, CB2307U2490068, CB2307U2490067, CB2307U2490066, CB2307U2490065, CB2307U2490064, CB2307U2490063, CB2307U2490062, CB2307U2490061, CB2307U2490060, CB2307U2490059, CB2307U2490058, CB2307U2490057, CB2207U2490056, CB2207U2490055, CB2207U2490054, CB2207U2490053, CB2207U2490052, CB2207U2490051, CB2207U2490050, CB2207U2490049, CB2207U2490048, CB2207U2490047, CB2207U2490046, CB2207U2490045, CB2207U2490044, CB2207U2490043, CB2207U2490042, CB2207U2490041, CB2207U2490040, CB2207U2490039, CB2207U2490038, CB2207U2490037, CB2207U2490036, CB2207U2490035, CB2207U2490034, CB2207U2490033, CB2207U2490032, CB2207U2490031, CB2207U2490030, CB2207U2490029, CB2207U2490028, CB2207U2490027, CB2207U2490026, CB2207U2490025, CB2207U2490024, CB2207U2490023, CB2207U2490022, CB2207U2490021, CB2207U2490020, CB2207U2490019, CB2207U2490018, CB2207U2490017, CB2207U2490016, CB2207U2490015, CB2207U2490014, CB2207U2490013, CB2207U2490012, CB2207U2490011, CB2207U2490010, CB2207U2490009, CB2207U2490008, CB2207U2490007, CB2207U2490006, CB2207U2490005, CB2207U2490004, CB2207U2490003, CB2207U2490002, CB2207U2490001, CB2203U2480068, CB2203U2480067, CB2203U2480066, CB2203U2480065, CB2203U2480064, CB2203U2480063, CB2203U2480062, CB2203U2480061, CB2203U2480060, CB2203U2480059, CB2203U2480058, CB2203U2480057, CB2203U2480056, CB2203U2480055, CB2203U2480054, CB2203U2480053, CB2203U2480052, CB2203U2480051, CB2203U2480050, CB2203U2480049, CB2203U2480048, CB2203U2480047, CB2203U2480046, CB2203U2480045, CB2203U2480044, CB2203U2480043, CB2203U2480042, CB2203U2480041, CB2203U2480040, CB2203U2480039, CB2203U2480038, CB2203U2480037, CB2203U2480036, CB2203U2480035, CB2203U2480034, CB2203U2480033, CB2203U2480032, CB2203U2480031, CB2203U2480030, CB2203U2480029, CB2203U2480028, CB2203U2480027, CB2203U2480026, CB2203U2480025, CB2203U2480024, CB2203U2480023, CB2203U2480022, CB2203U2480021, CB2203U2480020, CB2203U2480019, CB2203U2480018, CB2203U2480017, CB2203U2480016, CB2203U2480015, CB2203U2480014, CB2203U2480013, CB2203U2480012, CB2203U2480011, CB2203U2480010, CB2203U2480009, CB2203U2480008, CB2203U2480007, CB2203U2480006, CB2203U2480005, CB2203U2480004, CB2203U2480003, CB2203U2480002, CB2203U2480001, CB2307U2460068, CB2307U2460067, CB2307U2460066, CB2307U2460065, CB2307U2460064, CB2307U2460063, CB2307U2460062, CB2307U2460061, CB2307U2460060, CB2307U2460059, CB2307U2460058, CB2307U2460057, CB2307U2460056, CB2307U2460055, CB2307U2460054, CB2307U2460053, CB2207U2460052, CB2207U2460051, CB2207U2460050, CB2207U2460049, CB2207U2460048, CB2207U2460047, CB2207U2460046, CB2207U2460045, CB2207U2460044, CB2207U2460043, CB2207U2460042, CB2207U2460041, CB2207U2460040, CB2207U2460039, CB2207U2460038, CB2207U2460037, CB2207U2460036, CB2207U2460035, CB2207U2460034, CB2207U2460033, CB2207U2460032, CB2207U2460031, CB2207U2460030, CB2207U2460029, CB2207U2460028, CB2207U2460027, CB2207U2460026, CB2207U2460025, CB2207U2460024, CB2207U2460023, CB2207U2460022, CB2207U2460021, CB2207U2460020, CB2207U2460019, CB2207U2460018, CB2207U2460017, CB2207U2460016, CB2207U2460015, CB2207U2460014, CB2207U2460013, CB2207U2460012, CB2207U2460011, CB2207U2460010, CB2207U2460009, CB2207U2460008, CB2207U2460007, CB2207U2460006, CB2207U2460005, CB2207U2460004, CB2207U2460003, CB2207U2460002, CB2207U2460001, CB2307U2450068, CB2307U2450067, CB2307U2450066, CB2307U2450065, CB2307U2450064, CB2307U2450063, CB2307U2450062, CB2307U2450061, CB2307U2450060, CB2307U2450059, CB2307U2450058, CB2307U2450057, CB2207U2450056, CB2207U2450055, CB2207U2450054, CB2207U2450053, CB2207U2450052, CB2207U2450051, CB2207U2450050, CB2207U2450049, CB2207U2450048, CB2207U2450047, CB2207U2450046, CB2207U2450045, CB2207U2450044, CB2207U2450043, CB2207U2450042, CB2207U2450041, CB2207U2450040, CB2207U2450039, CB2207U2450038, CB2207U2450037, CB2207U2450036, CB2207U2450035, CB2207U2450034, CB2207U2450033, CB2207U2450032, CB2207U2450031, CB2207U2450030, CB2207U2450029, CB2207U2450028, CB2207U2450027, CB2207U2450026, CB2207U2450025, CB2207U2450024, CB2207U2450023, CB2207U2450022, CB2207U2450021, CB2207U2450020, CB2207U2450019, CB2207U2450018, CB2207U2450017, CB2207U2450016, CB2207U2450015, CB2207U2450014, CB2207U2450013, CB2207U2450012, CB2207U2450011, CB2207U2450010, CB2207U2450009, CB2207U2450008, CB2207U2450007, CB2207U2450006, CB2207U2450005, CB2207U2450004, CB2207U2450003, CB2207U2450002, CB2207U2450001, CB2307U2440202, CB2307U2440201, CB2307U2440200, CB2307U2440199, CB2307U2440198, CB2307U2440197, CB2307U2440196, CB2307U2440195, CB2307U2440194, CB2307U2440193, CB2307U2440192, CB2307U2440191, CB2307U2440190, CB2307U2440189, CB2307U2440188, CB2307U2440187, CB2307U2440186, CB2307U2440185, CB2307U2440184, CB2307U2440183, CB2307U2440182, CB2307U2440181, CB2307U2440180, CB2307U2440179, CB2307U2440178, CB2307U2440177, CB2307U2440176, CB2307U2440175, CB2307U2440174, CB2307U2440173, CB2307U2440172, CB2307U2440171, CB2307U2440170, CB2307U2440169, CB2307U2440168, CB2307U2440167, CB2307U2440166, CB2307U2440165, CB2307U2440164, CB2307U2440163, CB2307U2440162, CB2307U2440161, CB2307U2440160, CB2307U2440159, CB2307U2440158, CB2307U2440157, CB2307U2440156, CB2307U2440155, CB2307U2440154, CB2307U2440153, CB2307U2440152, CB2307U2440151, CB2307U2440150, CB2307U2440149, CB2307U2440148, CB2307U2440147, CB2307U2440146, CB2307U2440145, CB2307U2440144, CB2307U2440143, CB2307U2440142, CB2307U2440141, CB2307U2440140, CB2307U2440139, CB2307U2440138, CB2307U2440137, CB2307U2440136, CB2307U2440135, CB2307U2440068, CB2307U2440067, CB2307U2440066, CB2307U2440065, CB2307U2440064, CB2307U2440063, CB2307U2440062, CB2307U2440061, CB2307U2440060, CB2307U2440059, CB2307U2440058, CB2307U2440057, CB2307U2440056, CB2307U2440055, CB2307U2440054, CB2307U2440053, CB2307U2440052, CB2307U2440051, CB2307U2440050, CB2307U2440049, CB2307U2440048, CB2307U2440047, CB2307U2440046, CB2307U2440045, CB2307U2440044, CB2307U2440043, CB2307U2440042, CB2307U2440041, CB2307U2440040, CB2307U2440039, CB2307U2440038, CB2307U2440037, CB2307U2440036, CB2307U2440035, CB2307U2440034, CB2307U2440033, CB2307U2440032, CB2307U2440031, CB2307U2440030, CB2307U2440029, CB2307U2440028, CB2307U2440027, CB2307U2440026, CB2307U2440025, CB2307U2440024, CB2307U2440023, CB2307U2440022, CB2307U2440021, CB2307U2440020, CB2307U2440019, CB2307U2440018, CB2307U2440017, CB2307U2440016, CB2307U2440015, CB2307U2440014, CB2307U2440013, CB2307U2440012, CB2307U2440011, CB2307U2440010, CB2307U2440009, CB2307U2440008, CB2307U2440007, CB2307U2440006, CB2307U2440005, CB2307U2440004, CB2307U2440003, CB2307U2440002, CB2307U2440001, CB2203U2410267, CB2203U2410266, CB2203U2410265, CB2203U2410264, CB2203U2410263, CB2203U2410262, CB2203U2410261, CB2203U2410260, CB2203U2410259, CB2203U2410258, CB2203U2410257, CB2203U2410256, CB2203U2410255, CB2203U2410254, CB2203U2410253, CB2203U2410252, CB2203U2410251, CB2203U2410250, CB2203U2410249, CB2203U2410248, CB2203U2410247, CB2203U2410246, CB2203U2410245, CB2203U2410244, CB2203U2410243, CB2203U2410242, CB2203U2410241, CB2203U2410240, CB2203U2410239, CB2203U2410238, CB2203U2410237, CB2203U2410236, CB2203U2410235, CB2203U2410234, CB2203U2410233, CB2203U2410232, CB2203U2410231, CB2203U2410230, CB2203U2410229, CB2203U2410228, CB2203U2410227, CB2203U2410226, CB2203U2410225, CB2203U2410224, CB2203U2410223, CB2203U2410222, CB2203U2410221, CB2203U2410220, CB2203U2410219, CB2203U2410218, CB2203U2410217, CB2203U2410216, CB2203U2410215, CB2203U2410214, CB2203U2410213, CB2203U2410212, CB2203U2410211, CB2203U2410210, CB2203U2410209, CB2203U2410208, CB2203U2410207, CB2203U2410206, CB2203U2410205, CB2203U2410204, CB2203U2410203, CB2203U2410202, CB2203U2410201, CB2203U2410200, CB2207U2410068, CB2207U2410067, CB2207U2410066, CB2207U2410065, CB2207U2410064, CB2207U2410063, CB2207U2410062, CB2207U2410061, CB2207U2410060, CB2207U2410059, CB2207U2410058, CB2207U2410057, CB2207U2410056, CB2207U2410055, CB2207U2410054, CB2207U2410053, CB2207U2410052, CB2207U2410051, CB2207U2410050, CB2207U2410049, CB2207U2410048, CB2207U2410047, CB2207U2410046, CB2207U2410045, CB2207U2410044, CB2207U2410043, CB2207U2410042, CB2207U2410041, CB2207U2410040, CB2207U2410039, CB2207U2410038, CB2207U2410037, CB2207U2410036, CB2207U2410035, CB2207U2410034, CB2207U2410033, CB2207U2410032, CB2207U2410031, CB2207U2410030, CB2207U2410029, CB2207U2410028, CB2207U2410027, CB2207U2410026, CB2207U2410025, CB2207U2410024, CB2207U2410023, CB2207U2410022, CB2207U2410021, CB2207U2410020, CB2207U2410019, CB2207U2410018, CB2207U2410017, CB2207U2410016, CB2207U2410015, CB2207U2410014, CB2207U2410013, CB2207U2410012, CB2207U2410011, CB2207U2410010, CB2207U2410009, CB2207U2410008, CB2207U2410007, CB2207U2410006, CB2207U2410005, CB2207U2410004, CB2207U2410003, CB2207U2410002, CB2207U2410001, CB2203U2370252, CB2203U2370251, CB2203U2370250, CB2203U2370249, CB2203U2370248, CB2203U2370247, CB2203U2370246, CB2203U2370245, CB2203U2370244, CB2203U2370243, CB2203U2370242, CB2203U2370241, CB2203U2370240, CB2203U2370239, CB2203U2370238, CB2203U2370237, CB2203U2370236, CB2203U2370235, CB2203U2370234, CB2203U2370233, CB2203U2370232, CB2203U2370231, CB2203U2370230, CB2203U2370229, CB2203U2370228, CB2203U2370227, CB2203U2370226, CB2203U2370225, CB2203U2370224, CB2203U2370223, CB2203U2370222, CB2203U2370221, CB2203U2370220, CB2203U2370219, CB2203U2370218, CB2203U2370217, CB2203U2370216, CB2203U2370215, CB2203U2370214, CB2203U2370213, CB2203U2370212, CB2203U2370211, CB2203U2370210, CB2203U2370209, CB2203U2370208, CB2203U2370207, CB2203U2370206, CB2203U2370205, CB2203U2370204, CB2203U2370203, CB2203U2370202, CB2203U2370201, CB2203U2370200, CB2203U2370199, CB2203U2370198, CB2203U2370197, CB2203U2370196, CB2207U2370196, CB2203U2370195, CB2203U2370194, CB2203U2370193, CB2203U2370192, CB2203U2370191, CB2203U2370190, CB2203U2370189, CB2203U2370188, CB2203U2370187, CB2203U2370186, CB2203U2370185, CB2307U2370068, CB2307U2370067, CB2307U2370066, CB2307U2370065, CB2307U2370064, CB2307U2370063, CB2307U2370062, CB2307U2370061, CB2307U2370060, CB2307U2370059, CB2307U2370058, CB2307U2370057, CB2307U2370056, CB2307U2370055, CB2307U2370054, CB2307U2370053, CB2307U2370052, CB2307U2370051, CB2307U2370050, CB2307U2370049, CB2307U2370048, CB2307U2370047, CB2307U2370046, CB2307U2370045, CB2307U2370044, CB2307U2370043, CB2307U2370042, CB2307U2370041, CB2307U2370040, CB2307U2370039, CB2307U2370038, CB2307U2370037, CB2307U2370036, CB2307U2370035, CB2307U2370034, CB2307U2370033, CB2307U2370032, CB2307U2370031, CB2307U2370030, CB2307U2370029, CB2207U2370028, CB2207U2370027, CB2207U2370026, CB2207U2370025, CB2207U2370024, CB2207U2370023, CB2207U2370022, CB2207U2370021, CB2207U2370020, CB2207U2370019, CB2207U2370018, CB2207U2370017, CB2207U2370016, CB2207U2370015, CB2207U2370014, CB2207U2370013, CB2207U2370012, CB2207U2370011, CB2207U2370010, CB2207U2370009, CB2207U2370008, CB2207U2370007, CB2207U2370006, CB2207U2370005, CB2207U2370004, CB2207U2370003, CB2207U2370002, CB2207U2370001, CB2307U2310204, CB2307U2310203, CB2307U2310202, CB2307U2310201, CB2307U2310200, CB2307U2310199, CB2307U2310198, CB2307U2310197, CB2307U2310196, CB2307U2310195, CB2307U2310194, CB2307U2310193, CB2307U2310192, CB2207U2310191, CB2207U2310190, CB2207U2310189, CB2207U2310188, CB2207U2310187, CB2207U2310186, CB2207U2310185, CB2207U2310184, CB2207U2310183, CB2207U2310182, CB2207U2310181, CB2207U2310180, CB2207U2310179, CB2207U2310178, CB2207U2310177, CB2207U2310176, CB2207U2310175, CB2207U2310174, CB2207U2310173, CB2207U2310172, CB2107U2310171, CB2107U2310170, CB2107U2310169, CB2107U2310168, CB2107U2310167, CB2107U2310166, CB2107U2310165, CB2107U2310164, CB2107U2310163, CB2107U2310162, CB2107U2310161, CB2107U2310160, CB2107U2310159, CB2107U2310158, CB2107U2310157, CB2107U2310156, CB2107U2310155, CB2107U2310154, CB2107U2310153, CB2107U2310152, CB2107U2310151, CB2107U2310150, CB2107U2310149, CB2107U2310148, CB2107U2310147, CB2107U2310146, CB2107U2310145, CB2107U2310144, CB2107U2310143, CB2107U2310142, CB2107U2310141, CB2107U2310140, CB2107U2310139, CB2107U2310138, CB2107U2310137, CB2307U2310136, CB2307U2310135, CB2307U2310134, CB2307U2310133, CB2307U2310132, CB2307U2310131, CB2307U2310130, CB2307U2310129, CB2307U2310128, CB2307U2310127, CB2307U2310126, CB2307U2310125, CB2307U2310124, CB2207U2310123, CB2207U2310122, CB2207U2310121, CB2207U2310120, CB2207U2310119, CB2207U2310118, CB2207U2310117, CB2207U2310116, CB2207U2310115, CB2207U2310114, CB2207U2310113, CB2207U2310112, CB2207U2310111, CB2207U2310110, CB2207U2310109, CB2207U2310108, CB2207U2310107, CB2207U2310106, CB2207U2310105, CB2207U2310104, CB2107U2310103, CB2107U2310102, CB2107U2310101, CB2107U2310100, CB2107U2310099, CB2107U2310098, CB2107U2310097, CB2107U2310096, CB2107U2310095, CB2107U2310094, CB2107U2310093, CB2107U2310092, CB2107U2310091, CB2107U2310090, CB2107U2310089, CB2107U2310088, CB2107U2310087, CB2107U2310086, CB2107U2310085, CB2107U2310084, CB2107U2310083, CB2107U2310082, CB2107U2310081, CB2107U2310080, CB2107U2310079, CB2107U2310078, CB2107U2310077, CB2107U2310076, CB2107U2310075, CB2107U2310074, CB2107U2310073, CB2107U2310072, CB2107U2310071, CB2107U2310070, CB2107U2310069, CB2307U2310068, CB2307U2310067, CB2307U2310066, CB2307U2310065, CB2307U2310064, CB2307U2310063, CB2307U2310062, CB2307U2310061, CB2307U2310060, CB2307U2310059, CB2307U2310058, CB2307U2310057, CB2307U2310056, CB2307U2310055, CB2207U2310054, CB2207U2310053, CB2207U2310052, CB2207U2310051, CB2207U2310050, CB2207U2310049, CB2207U2310048, CB2207U2310047, CB2207U2310046, CB2207U2310045, CB2207U2310044, CB2207U2310043, CB2207U2310042, CB2207U2310041, CB2207U2310040, CB2207U2310039, CB2207U2310038, CB2207U2310037, CB2207U2310036, CB2207U2310035, CB2107U2310034, CB2107U2310033, CB2107U2310032, CB2107U2310031, CB2107U2310030, CB2107U2310029, CB2107U2310028, CB2107U2310027, CB2107U2310026, CB2107U2310025, CB2107U2310024, CB2107U2310023, CB2107U2310022, CB2107U2310021, CB2107U2310020, CB2107U2310019, CB2107U2310018, CB2107U2310017, CB2107U2310016, CB2107U2310015, CB2107U2310014, CB2107U2310013, CB2107U2310012, CB2107U2310011, CB2107U2310010, CB2107U2310009, CB2107U2310008, CB2107U2310007, CB2107U2310006, CB2107U2310005, CB2107U2310004, CB2107U2310003, CB2107U2310002, CB2107U2310001, CB2207U22C0204, CB2207U22C0203, CB2207U22C0202, CB2207U22C0201, CB2207U22C0200, CB2207U22C0199, CB2207U22C0198, CB2207U22C0197, CB2207U22C0196, CB2207U22C0195, CB2207U22C0194, CB2207U22C0193, CB2207U22C0192, CB2207U22C0191, CB2207U22C0190, CB2207U22C0189, CB2207U22C0188, CB2207U22C0187, CB2207U22C0186, CB2207U22C0185, CB2207U22C0184, CB2207U22C0183, CB2207U22C0182, CB2207U22C0181, CB2207U22C0180, CB2207U22C0179, CB2207U22C0178, CB2207U22C0177, CB2207U22C0176, CB2207U22C0175, CB2207U22C0174, CB2207U22C0173, CB2207U22C0172, CB2207U22C0171, CB2207U22C0170, CB2207U22C0169, CB2207U22C0168, CB2207U22C0167, CB2207U22C0166, CB2207U22C0165, CB2207U22C0164, CB2207U22C0163, CB2207U22C0162, CB2207U22C0161, CB2207U22C0160, CB2207U22C0159, CB2207U22C0158, CB2207U22C0157, CB2207U22C0156, CB2207U22C0155, CB2207U22C0154, CB2207U22C0153, CB2207U22C0152, CB2207U22C0151, CB2207U22C0150, CB2207U22C0149, CB2207U22C0148, CB2207U22C0147, CB2107U22C0146, CB2107U22C0145, CB2107U22C0144, CB2107U22C0143, CB2107U22C0142, CB2107U22C0141, CB2107U22C0140, CB2107U22C0139, CB2107U22C0138, CB2107U22C0137, CB2207U22C0136, CB2207U22C0135, CB2207U22C0134, CB2207U22C0133, CB2207U22C0132, CB2207U22C0131, CB2207U22C0130, CB2207U22C0129, CB2207U22C0128, CB2207U22C0127, CB2207U22C0126, CB2207U22C0125, CB2207U22C0124, CB2207U22C0123, CB2207U22C0122, CB2207U22C0121, CB2207U22C0120, CB2207U22C0119, CB2207U22C0118, CB2207U22C0117, CB2207U22C0116, CB2207U22C0115, CB2207U22C0114, CB2207U22C0113, CB2207U22C0112, CB2207U22C0111, CB2207U22C0110, CB2207U22C0109, CB2207U22C0108, CB2207U22C0107, CB2207U22C0106, CB2207U22C0105, CB2207U22C0104, CB2207U22C0103, CB2207U22C0102, CB2207U22C0101, CB2207U22C0100, CB2207U22C0099, CB2207U22C0098, CB2207U22C0097, CB2207U22C0096, CB2207U22C0095, CB2207U22C0094, CB2207U22C0093, CB2207U22C0092, CB2207U22C0091, CB2207U22C0090, CB2207U22C0089, CB2207U22C0088, CB2207U22C0087, CB2207U22C0086, CB2207U22C0085, CB2207U22C0084, CB2207U22C0083, CB2207U22C0082, CB2207U22C0081, CB2207U22C0080, CB2207U22C0079, CB2107U22C0078, CB2107U22C0077, CB2107U22C0076, CB2107U22C0075, CB2107U22C0074, CB2107U22C0073, CB2107U22C0072, CB2107U22C0071, CB2107U22C0070, CB2107U22C0069, CB2207U22C0068, CB2307U22C0068, CB2207U22C0067, CB2307U22C0067, CB2207U22C0066, CB2307U22C0066, CB2207U22C0065, CB2307U22C0065, CB2207U22C0064, CB2307U22C0064, CB2207U22C0063, CB2307U22C0063, CB2207U22C0062, CB2307U22C0062, CB2207U22C0061, CB2307U22C0061, CB2207U22C0060, CB2307U22C0060, CB2207U22C0059, CB2307U22C0059, CB2207U22C0058, CB2307U22C0058, CB2207U22C0057, CB2307U22C0057, CB2207U22C0056, CB2307U22C0056, CB2207U22C0055, CB2307U22C0055, CB2207U22C0054, CB2307U22C0054, CB2207U22C0053, CB2307U22C0053, CB2207U22C0052, CB2307U22C0052, CB2207U22C0051, CB2307U22C0051, CB2207U22C0050, CB2307U22C0050, CB2207U22C0049, CB2307U22C0049, CB2207U22C0048, CB2307U22C0048, CB2207U22C0047, CB2307U22C0047, CB2207U22C0046, CB2307U22C0046, CB2207U22C0045, CB2307U22C0045, CB2207U22C0044, CB2307U22C0044, CB2207U22C0043, CB2307U22C0043, CB2207U22C0042, CB2307U22C0042, CB2207U22C0041, CB2307U22C0041, CB2207U22C0040, CB2307U22C0040, CB2207U22C0039, CB2307U22C0039, CB2207U22C0038, CB2307U22C0038, CB2207U22C0037, CB2307U22C0037, CB2207U22C0036, CB2307U22C0036, CB2207U22C0035, CB2307U22C0035, CB2207U22C0034, CB2307U22C0034, CB2207U22C0033, CB2307U22C0033, CB2207U22C0032, CB2307U22C0032, CB2207U22C0031, CB2307U22C0031, CB2207U22C0030, CB2307U22C0030, CB2207U22C0029, CB2307U22C0029, CB2207U22C0028, CB2307U22C0028, CB2207U22C0027, CB2307U22C0027, CB2207U22C0026, CB2307U22C0026, CB2207U22C0025, CB2307U22C0025, CB2207U22C0024, CB2307U22C0024, CB2207U22C0023, CB2307U22C0023, CB2207U22C0022, CB2307U22C0022, CB2207U22C0021, CB2307U22C0021, CB2207U22C0020, CB2307U22C0020, CB2207U22C0019, CB2307U22C0019, CB2207U22C0018, CB2307U22C0018, CB2207U22C0017, CB2307U22C0017, CB2207U22C0016, CB2307U22C0016, CB2207U22C0015, CB2307U22C0015, CB2207U22C0014, CB2307U22C0014, CB2207U22C0013, CB2307U22C0013, CB2207U22C0012, CB2307U22C0012, CB2207U22C0011, CB2307U22C0011, CB2107U22C0010, CB2107U22C0009, CB2107U22C0008, CB2107U22C0007, CB2107U22C0006, CB2107U22C0005, CB2107U22C0004, CB2107U22C0003, CB2107U22C0002, CB2107U22C0001, CB2307U22B0336, CB2307U22B0335, CB2307U22B0334, CB2307U22B0333, CB2307U22B0332, CB2307U22B0331, CB2307U22B0330, CB2307U22B0329, CB2307U22B0328, CB2307U22B0327, CB2307U22B0326, CB2307U22B0325, CB2307U22B0324, CB2307U22B0323, CB2307U22B0322, CB2307U22B0321, CB2307U22B0320, CB2307U22B0319, CB2307U22B0318, CB2307U22B0317, CB2307U22B0316, CB2307U22B0315, CB2307U22B0314, CB2307U22B0313, CB2307U22B0312, CB2307U22B0311, CB2307U22B0310, CB2307U22B0309, CB2307U22B0308, CB2307U22B0307, CB2307U22B0306, CB2307U22B0305, CB2307U22B0304, CB2307U22B0303, CB2307U22B0302, CB2307U22B0301, CB2307U22B0300, CB2307U22B0299, CB2307U22B0298, CB2307U22B0297, CB2107U22B0296, CB2107U22B0295, CB2107U22B0294, CB2107U22B0293, CB2107U22B0292, CB2107U22B0291, CB2107U22B0290, CB2107U22B0289, CB2107U22B0288, CB2107U22B0287, CB2107U22B0286, CB2107U22B0285, CB2107U22B0284, CB2107U22B0283, CB2107U22B0282, CB2107U22B0281, CB2107U22B0280, CB2107U22B0279, CB2107U22B0278, CB2107U22B0277, CB2107U22B0276, CB2107U22B0275, CB2107U22B0274, CB2107U22B0273, CB2107U22B0272, CB2107U22B0271, CB2107U22B0270, CB2107U22B0269, CB2307U22B0268, CB2307U22B0267, CB2307U22B0266, CB2307U22B0265, CB2307U22B0264, CB2307U22B0263, CB2307U22B0262, CB2307U22B0261, CB2307U22B0260, CB2307U22B0259, CB2307U22B0258, CB2307U22B0257, CB2307U22B0256, CB2307U22B0255, CB2307U22B0254, CB2207U22B0253, CB2207U22B0252, CB2207U22B0251, CB2207U22B0250, CB2207U22B0249, CB2207U22B0248, CB2207U22B0247, CB2207U22B0246, CB2207U22B0245, CB2207U22B0244, CB2207U22B0243, CB2207U22B0242, CB2207U22B0241, CB2207U22B0240, CB2207U22B0239, CB2207U22B0238, CB2207U22B0237, CB2207U22B0236, CB2207U22B0235, CB2207U22B0234, CB2207U22B0233, CB2207U22B0232, CB2207U22B0231, CB2207U22B0230, CB2207U22B0229, CB2207U22B0228, CB2207U22B0227, CB2207U22B0226, CB2207U22B0225, CB2207U22B0224, CB2207U22B0223, CB2207U22B0222, CB2207U22B0221, CB2207U22B0220, CB2207U22B0219, CB2207U22B0218, CB2207U22B0217, CB2207U22B0216, CB2207U22B0215, CB2207U22B0214, CB2207U22B0213, CB2207U22B0212, CB2207U22B0211, CB2207U22B0210, CB2207U22B0209, CB2207U22B0208, CB2207U22B0207, CB2207U22B0206, CB2207U22B0205, CB2207U22B0204, CB2207U22B0203, CB2207U22B0202, CB2207U22B0201, CB2307U22B0200, CB2307U22B0199, CB2307U22B0198, CB2307U22B0197, CB2307U22B0196, CB2307U22B0195, CB2307U22B0194, CB2307U22B0193, CB2307U22B0192, CB2307U22B0191, CB2307U22B0190, CB2307U22B0189, CB2307U22B0188, CB2307U22B0187, CB2307U22B0186, CB2207U22B0185, CB2207U22B0184, CB2207U22B0183, CB2207U22B0182, CB2207U22B0181, CB2207U22B0180, CB2207U22B0179, CB2207U22B0178, CB2207U22B0177, CB2207U22B0176, CB2207U22B0175, CB2207U22B0174, CB2207U22B0173, CB2207U22B0172, CB2207U22B0171, CB2207U22B0170, CB2207U22B0169, CB2207U22B0168, CB2207U22B0167, CB2207U22B0166, CB2207U22B0165, CB2207U22B0164, CB2207U22B0163, CB2207U22B0162, CB2207U22B0161, CB2207U22B0160, CB2207U22B0159, CB2207U22B0158, CB2207U22B0157, CB2207U22B0156, CB2207U22B0155, CB2207U22B0154, CB2207U22B0153, CB2207U22B0152, CB2207U22B0151, CB2207U22B0150, CB2207U22B0149, CB2207U22B0148, CB2207U22B0147, CB2207U22B0146, CB2207U22B0145, CB2207U22B0144, CB2207U22B0143, CB2107U22B0142, CB2107U22B0141, CB2107U22B0140, CB2107U22B0139, CB2107U22B0138, CB2107U22B0137, CB2107U22B0136, CB2107U22B0135, CB2107U22B0134, CB2107U22B0133, CB2307U22A0202, CB2307U22A0201, CB2307U22A0200, CB2307U22A0199, CB2307U22A0198, CB2307U22A0197, CB2307U22A0196, CB2307U22A0195, CB2307U22A0194, CB2307U22A0193, CB2307U22A0192, CB2307U22A0191, CB2307U22A0190, CB2307U22A0189, CB2307U22A0188, CB2207U22A0187, CB2207U22A0186, CB2207U22A0185, CB2207U22A0184, CB2207U22A0183, CB2207U22A0182, CB2207U22A0181, CB2207U22A0180, CB2207U22A0179, CB2207U22A0178, CB2207U22A0177, CB2207U22A0176, CB2207U22A0175, CB2207U22A0174, CB2207U22A0173, CB2207U22A0172, CB2207U22A0171, CB2207U22A0170, CB2207U22A0169, CB2207U22A0168, CB2207U22A0167, CB2207U22A0166, CB2207U22A0165, CB2207U22A0164, CB2207U22A0163, CB2207U22A0162, CB2207U22A0161, CB2207U22A0160, CB2207U22A0159, CB2207U22A0158, CB2207U22A0157, CB2207U22A0156, CB2207U22A0155, CB2207U22A0154, CB2207U22A0153, CB2207U22A0152, CB2207U22A0151, CB2207U22A0150, CB2207U22A0149, CB2207U22A0148, CB2207U22A0147, CB2107U22A0146, CB2107U22A0145, CB2107U22A0144, CB2107U22A0143, CB2107U22A0142, CB2107U22A0141, CB2107U22A0140, CB2107U22A0139, CB2107U22A0138, CB2107U22A0137, CB2107U22A0136, CB2107U22A0135, CB2307U22A0134, CB2307U22A0133, CB2307U22A0132, CB2307U22A0131, CB2307U22A0130, CB2307U22A0129, CB2307U22A0128, CB2307U22A0127, CB2307U22A0126, CB2307U22A0125, CB2307U22A0124, CB2307U22A0123, CB2307U22A0122, CB2307U22A0121, CB2307U22A0120, CB2207U22A0119, CB2207U22A0118, CB2207U22A0117, CB2207U22A0116, CB2207U22A0115, CB2207U22A0114, CB2207U22A0113, CB2207U22A0112, CB2207U22A0111, CB2207U22A0110, CB2207U22A0109, CB2207U22A0108, CB2207U22A0107, CB2207U22A0106, CB2207U22A0105, CB2207U22A0104, CB2207U22A0103, CB2207U22A0102, CB2207U22A0101, CB2207U22A0100, CB2207U22A0099, CB2207U22A0098, CB2207U22A0097, CB2207U22A0096, CB2207U22A0095, CB2207U22A0094, CB2207U22A0093, CB2207U22A0092, CB2207U22A0091, CB2207U22A0090, CB2207U22A0089, CB2207U22A0088, CB2207U22A0087, CB2207U22A0086, CB2207U22A0085, CB2207U22A0084, CB2207U22A0083, CB2207U22A0082, CB2207U22A0081, CB2207U22A0080, CB2207U22A0079, CB2107U22A0078, CB2107U22A0077, CB2107U22A0076, CB2107U22A0075, CB2107U22A0074, CB2107U22A0073, CB2107U22A0072, CB2107U22A0071, CB2107U22A0070, CB2107U22A0069, CB2107U22A0068, CB2107U22A0067, CB2307U2290270, CB2307U2290269, CB2307U2290268, CB2307U2290267, CB2307U2290266, CB2307U2290265, CB2307U2290264, CB2307U2290263, CB2307U2290262, CB2307U2290261, CB2207U2290260, CB2207U2290259, CB2207U2290258, CB2207U2290257, CB2207U2290256, CB2207U2290255, CB2207U2290254, CB2207U2290253, CB2207U2290252, CB2207U2290251, CB2207U2290250, CB2207U2290249, CB2207U2290248, CB2207U2290247, CB2207U2290246, CB2207U2290245, CB2207U2290244, CB2207U2290243, CB2207U2290242, CB2207U2290241, CB2207U2290240, CB2207U2290239, CB2207U2290238, CB2207U2290237, CB2207U2290236, CB2207U2290235, CB2207U2290234, CB2207U2290233, CB2207U2290232, CB2207U2290231, CB2207U2290230, CB2207U2290229, CB2207U2290228, CB2207U2290227, CB2207U2290226, CB2207U2290225, CB2207U2290224, CB2207U2290223, CB2207U2290222, CB2207U2290221, CB2107U2290220, CB2107U2290219, CB2107U2290218, CB2107U2290217, CB2107U2290216, CB2107U2290215, CB2107U2290214, CB2107U2290213, CB2107U2290212, CB2107U2290211, CB2107U2290210, CB2107U2290209, CB2107U2290208, CB2107U2290207, CB2107U2290206, CB2107U2290205, CB2107U2290204, CB2107U2290203, CB2307U2290136, CB2307U2290135, CB2307U2290134, CB2307U2290133, CB2307U2290132, CB2307U2290131, CB2307U2290130, CB2307U2290129, CB2307U2290128, CB2307U2290127, CB2207U2290126, CB2207U2290125, CB2207U2290124, CB2207U2290123, CB2207U2290122, CB2207U2290121, CB2207U2290120, CB2207U2290119, CB2207U2290118, CB2207U2290117, CB2207U2290116, CB2207U2290115, CB2207U2290114, CB2207U2290113, CB2207U2290112, CB2207U2290111, CB2207U2290110, CB2207U2290109, CB2207U2290108, CB2207U2290107, CB2207U2290106, CB2207U2290105, CB2207U2290104, CB2207U2290103, CB2207U2290102, CB2207U2290101, CB2207U2290100, CB2207U2290099, CB2207U2290098, CB2207U2290097, CB2207U2290096, CB2207U2290095, CB2207U2290094, CB2207U2290093, CB2207U2290092, CB2207U2290091, CB2207U2290090, CB2207U2290089, CB2207U2290088, CB2207U2290087, CB2107U2290086, CB2107U2290085, CB2107U2290084, CB2107U2290083, CB2107U2290082, CB2107U2290081, CB2107U2290080, CB2107U2290079, CB2107U2290078, CB2107U2290077, CB2107U2290076, CB2107U2290075, CB2107U2290074, CB2107U2290073, CB2107U2290072, CB2107U2290071, CB2107U2290070, CB2107U2290069, CB2307U2290068, CB2307U2290067, CB2307U2290066, CB2307U2290065, CB2307U2290064, CB2307U2290063, CB2307U2290062, CB2307U2290061, CB2307U2290060, CB2307U2290059, CB2207U2290058, CB2207U2290057, CB2207U2290056, CB2207U2290055, CB2207U2290054, CB2207U2290053, CB2207U2290052, CB2207U2290051, CB2207U2290050, CB2207U2290049, CB2207U2290048, CB2207U2290047, CB2207U2290046, CB2207U2290045, CB2207U2290044, CB2207U2290043, CB2207U2290042, CB2207U2290041, CB2207U2290040, CB2207U2290039, CB2207U2290038, CB2207U2290037, CB2207U2290036, CB2207U2290035, CB2207U2290034, CB2207U2290033, CB2207U2290032, CB2207U2290031, CB2207U2290030, CB2207U2290029, CB2207U2290028, CB2207U2290027, CB2207U2290026, CB2207U2290025, CB2207U2290024, CB2207U2290023, CB2207U2290022, CB2207U2290021, CB2207U2290020, CB2207U2290019, CB2107U2290018, CB2107U2290017, CB2107U2290016, CB2107U2290015, CB2107U2290014, CB2107U2290013, CB2107U2290012, CB2107U2290011, CB2107U2290010, CB2107U2290009, CB2107U2290008, CB2107U2290007, CB2107U2290006, CB2107U2290005, CB2107U2290004, CB2107U2290003, CB2107U2290002, CB2107U2290001, CB2307U2280338, CB2307U2280337, CB2307U2280336, CB2307U2280335, CB2307U2280334, CB2307U2280333, CB2307U2280332, CB2307U2280331, CB2307U2280330, CB2307U2280329, CB2307U2280328, CB2307U2280327, CB2307U2280326, CB2307U2280325, CB2307U2280324, CB2307U2280323, CB2307U2280322, CB2307U2280321, CB2307U2280320, CB2307U2280319, CB2207U2280318, CB2207U2280317, CB2207U2280316, CB2207U2280315, CB2207U2280314, CB2207U2280313, CB2207U2280312, CB2207U2280311, CB2207U2280310, CB2207U2280309, CB2207U2280308, CB2207U2280307, CB2207U2280306, CB2207U2280305, CB2207U2280304, CB2207U2280303, CB2207U2280302, CB2207U2280301, CB2207U2280300, CB2207U2280299, CB2207U2280298, CB2207U2280297, CB2207U2280296, CB2207U2280295, CB2207U2280294, CB2207U2280293, CB2207U2280292, CB2207U2280291, CB2207U2280290, CB2207U2280289, CB2207U2280288, CB2207U2280287, CB2207U2280286, CB2107U2280285, CB2107U2280284, CB2107U2280283, CB2107U2280282, CB2107U2280281, CB2107U2280280, CB2107U2280279, CB2107U2280278, CB2107U2280277, CB2107U2280276, CB2107U2280275, CB2107U2280274, CB2107U2280273, CB2107U2280272, CB2107U2280271, CB2307U2280270, CB2307U2280269, CB2307U2280268, CB2307U2280267, CB2307U2280266, CB2307U2280265, CB2307U2280264, CB2307U2280263, CB2307U2280262, CB2307U2280261, CB2307U2280260, CB2307U2280259, CB2307U2280258, CB2307U2280257, CB2307U2280256, CB2307U2280255, CB2307U2280254, CB2307U2280253, CB2307U2280252, CB2307U2280251, CB2207U2280250, CB2207U2280249, CB2207U2280248, CB2207U2280247, CB2207U2280246, CB2207U2280245, CB2207U2280244, CB2207U2280243, CB2207U2280242, CB2207U2280241, CB2207U2280240, CB2207U2280239, CB2207U2280238, CB2207U2280237, CB2207U2280236, CB2207U2280235, CB2207U2280234, CB2207U2280233, CB2207U2280232, CB2207U2280231, CB2207U2280230, CB2207U2280229, CB2207U2280228, CB2207U2280227, CB2207U2280226, CB2207U2280225, CB2207U2280224, CB2207U2280223, CB2207U2280222, CB2207U2280221, CB2207U2280220, CB2207U2280219, CB2207U2280218, CB2107U2280217, CB2107U2280216, CB2107U2280215, CB2107U2280214, CB2107U2280213, CB2107U2280212, CB2107U2280211, CB2107U2280210, CB2107U2280209, CB2107U2280208, CB2107U2280207, CB2107U2280206, CB2107U2280205, CB2107U2280204, CB2107U2280203, CB2307U2280136, CB2307U2280135, CB2307U2280134, CB2307U2280133, CB2307U2280132, CB2307U2280131, CB2307U2280130, CB2307U2280129, CB2307U2280128, CB2307U2280127, CB2307U2280126, CB2307U2280125, CB2307U2280124, CB2307U2280123, CB2307U2280122, CB2307U2280121, CB2307U2280120, CB2307U2280119, CB2307U2280118, CB2307U2280117, CB2207U2280116, CB2207U2280115, CB2207U2280114, CB2207U2280113, CB2207U2280112, CB2207U2280111, CB2207U2280110, CB2207U2280109, CB2207U2280108, CB2207U2280107, CB2207U2280106, CB2207U2280105, CB2207U2280104, CB2207U2280103, CB2207U2280102, CB2207U2280101, CB2207U2280100, CB2207U2280099, CB2207U2280098, CB2207U2280097, CB2207U2280096, CB2207U2280095, CB2207U2280094, CB2207U2280093, CB2207U2280092, CB2207U2280091, CB2207U2280090, CB2207U2280089, CB2207U2280088, CB2207U2280087, CB2207U2280086, CB2207U2280085, CB2107U2280084, CB2107U2280083, CB2107U2280082, CB2107U2280081, CB2107U2280080, CB2107U2280079, CB2107U2280078, CB2107U2280077, CB2107U2280076, CB2107U2280075, CB2107U2280074, CB2107U2280073, CB2107U2280072, CB2107U2280071, CB2107U2280070, CB2107U2280069, CB2307U2280068, CB2307U2280067, CB2307U2280066, CB2307U2280065, CB2307U2280064, CB2307U2280063, CB2307U2280062, CB2307U2280061, CB2307U2280060, CB2307U2280059, CB2307U2280058, CB2307U2280057, CB2307U2280056, CB2307U2280055, CB2307U2280054, CB2307U2280053, CB2307U2280052, CB2307U2280051, CB2207U2280050, CB2207U2280049, CB2207U2280048, CB2207U2280047, CB2207U2280046, CB2207U2280045, CB2207U2280044, CB2207U2280043, CB2207U2280042, CB2207U2280041, CB2207U2280040, CB2207U2280039, CB2207U2280038, CB2207U2280037, CB2207U2280036, CB2207U2280035, CB2207U2280034, CB2207U2280033, CB2207U2280032, CB2207U2280031, CB2207U2280030, CB2207U2280029, CB2207U2280028, CB2207U2280027, CB2207U2280026, CB2207U2280025, CB2207U2280024, CB2207U2280023, CB2207U2280022, CB2207U2280021, CB2207U2280020, CB2207U2280019, CB2207U2280018, CB2207U2280017, CB2207U2280016, CB2207U2280015, CB2207U2280014, CB2207U2280013, CB2207U2280012, CB2207U2280011, CB2207U2280010, CB2207U2280009, CB2207U2280008, CB2207U2280007, CB2207U2280006, CB2107U2280005, CB2107U2280004, CB2107U2280003, CB2107U2280002, CB2107U2280001, CB2307U2270268, CB2307U2270267, CB2307U2270266, CB2307U2270265, CB2307U2270264, CB2307U2270263, CB2307U2270262, CB2307U2270261, CB2307U2270260, CB2307U2270259, CB2307U2270258, CB2307U2270257, CB2307U2270256, CB2307U2270255, CB2307U2270254, CB2307U2270253, CB2307U2270252, CB2307U2270251, CB2207U2270250, CB2207U2270249, CB2207U2270248, CB2207U2270247, CB2207U2270246, CB2207U2270245, CB2207U2270244, CB2207U2270243, CB2207U2270242, CB2207U2270241, CB2207U2270240, CB2207U2270239, CB2207U2270238, CB2207U2270237, CB2207U2270236, CB2207U2270235, CB2207U2270234, CB2207U2270233, CB2207U2270232, CB2207U2270231, CB2207U2270230, CB2207U2270229, CB2207U2270228, CB2207U2270227, CB2207U2270226, CB2207U2270225, CB2207U2270224, CB2207U2270223, CB2207U2270222, CB2207U2270221, CB2207U2270220, CB2207U2270219, CB2207U2270218, CB2207U2270217, CB2207U2270216, CB2207U2270215, CB2207U2270214, CB2207U2270213, CB2207U2270212, CB2207U2270211, CB2207U2270210, CB2207U2270209, CB2207U2270208, CB2207U2270207, CB2207U2270206, CB2107U2270205, CB2107U2270204, CB2107U2270203, CB2107U2270202, CB2107U2270201, CB2307U2270200, CB2307U2270199, CB2307U2270198, CB2307U2270197, CB2307U2270196, CB2307U2270195, CB2307U2270194, CB2307U2270193, CB2307U2270192, CB2307U2270191, CB2307U2270190, CB2307U2270189, CB2307U2270188, CB2307U2270187, CB2307U2270186, CB2307U2270185, CB2307U2270184, CB2307U2270183, CB2307U2270182, CB2307U2270181, CB2307U2270180, CB2307U2270179, CB2307U2270178, CB2307U2270177, CB2307U2270176, CB2307U2270175, CB2307U2270174, CB2307U2270173, CB2307U2270172, CB2307U2270171, CB2307U2270170, CB2307U2270169, CB2307U2270168, CB2307U2270167, CB2307U2270166, CB2307U2270165, CB2307U2270164, CB2307U2270163, CB2307U2270162, CB2307U2270161, CB2307U2270160, CB2307U2270159, CB2307U2270158, CB2307U2270157, CB2307U2270156, CB2307U2270155, CB2307U2270154, CB2307U2270153, CB2107U2270152, CB2107U2270151, CB2107U2270150, CB2107U2270149, CB2107U2270148, CB2107U2270147, CB2107U2270146, CB2107U2270145, CB2107U2270144, CB2107U2270143, CB2107U2270142, CB2107U2270141, CB2107U2270140, CB2107U2270139, CB2107U2270138, CB2107U2270137, CB2107U2270136, CB2107U2270135, CB2107U2270134, CB2107U2270133, CB2307U2260270, CB2307U2260269, CB2307U2260268, CB2307U2260267, CB2307U2260266, CB2307U2260265, CB2307U2260264, CB2307U2260263, CB2307U2260262, CB2307U2260261, CB2307U2260260, CB2307U2260259, CB2307U2260258, CB2307U2260257, CB2307U2260256, CB2307U2260255, CB2207U2260254, CB2207U2260253, CB2207U2260252, CB2207U2260251, CB2207U2260250, CB2207U2260249, CB2207U2260248, CB2207U2260247, CB2207U2260246, CB2207U2260245, CB2207U2260244, CB2207U2260243, CB2207U2260242, CB2207U2260241, CB2207U2260240, CB2207U2260239, CB2207U2260238, CB2207U2260237, CB2207U2260236, CB2207U2260235, CB2207U2260234, CB2207U2260233, CB2207U2260232, CB2207U2260231, CB2207U2260230, CB2207U2260229, CB2207U2260228, CB2207U2260227, CB2207U2260226, CB2207U2260225, CB2107U2260224, CB2107U2260223, CB2107U2260222, CB2107U2260221, CB2107U2260220, CB2107U2260219, CB2107U2260218, CB2107U2260217, CB2107U2260216, CB2107U2260215, CB2107U2260214, CB2107U2260213, CB2107U2260212, CB2107U2260211, CB2107U2260210, CB2107U2260209, CB2107U2260208, CB2107U2260207, CB2107U2260206, CB2107U2260205, CB2107U2260204, CB2107U2260203, CB2307U2260202, CB2307U2260201, CB2307U2260200, CB2307U2260199, CB2307U2260198, CB2307U2260197, CB2307U2260196, CB2307U2260195, CB2307U2260194, CB2307U2260193, CB2307U2260192, CB2307U2260191, CB2307U2260190, CB2307U2260189, CB2207U2260188, CB2207U2260187, CB2207U2260186, CB2207U2260185, CB2207U2260184, CB2207U2260183, CB2207U2260182, CB2207U2260181, CB2207U2260180, CB2207U2260179, CB2207U2260178, CB2207U2260177, CB2207U2260176, CB2207U2260175, CB2207U2260174, CB2207U2260173, CB2207U2260172, CB2207U2260171, CB2207U2260170, CB2207U2260169, CB2207U2260168, CB2207U2260167, CB2207U2260166, CB2207U2260165, CB2207U2260164, CB2207U2260163, CB2207U2260162, CB2207U2260161, CB2207U2260160, CB2207U2260159, CB2207U2260158, CB2207U2260157, CB2207U2260156, CB2207U2260155, CB2207U2260154, CB2207U2260153, CB2207U2260152, CB2207U2260151, CB2207U2260150, CB2207U2260149, CB2207U2260148, CB2207U2260147, CB2207U2260146, CB2207U2260145, CB2207U2260144, CB2207U2260143, CB2207U2260142, CB2207U2260141, CB2207U2260140, CB2207U2260139, CB2107U2260138, CB2107U2260137, CB2107U2260136, CB2107U2260135, CB2307U2260134, CB2307U2260133, CB2307U2260132, CB2307U2260131, CB2307U2260130, CB2307U2260129, CB2307U2260128, CB2307U2260127, CB2307U2260126, CB2307U2260125, CB2307U2260124, CB2307U2260123, CB2307U2260122, CB2307U2260121, CB2207U2260120, CB2207U2260119, CB2207U2260118, CB2207U2260117, CB2207U2260116, CB2207U2260115, CB2207U2260114, CB2207U2260113, CB2207U2260112, CB2207U2260111, CB2207U2260110, CB2207U2260109, CB2207U2260108, CB2207U2260107, CB2207U2260106, CB2207U2260105, CB2207U2260104, CB2207U2260103, CB2207U2260102, CB2207U2260101, CB2207U2260100, CB2207U2260099, CB2207U2260098, CB2207U2260097, CB2207U2260096, CB2207U2260095, CB2207U2260094, CB2207U2260093, CB2207U2260092, CB2207U2260091, CB2207U2260090, CB2207U2260089, CB2207U2260088, CB2207U2260087, CB2207U2260086, CB2207U2260085, CB2207U2260084, CB2207U2260083, CB2207U2260082, CB2207U2260081, CB2207U2260080, CB2207U2260079, CB2207U2260078, CB2207U2260077, CB2207U2260076, CB2207U2260075, CB2207U2260074, CB2207U2260073, CB2207U2260072, CB2207U2260071, CB2107U2260070, CB2107U2260069, CB2107U2260068, CB2107U2260067, CB2307U2250136, CB2307U2250135, CB2307U2250134, CB2307U2250133, CB2307U2250132, CB2307U2250131, CB2307U2250130, CB2307U2250129, CB2307U2250128, CB2307U2250127, CB2307U2250126, CB2307U2250125, CB2307U2250124, CB2307U2250123, CB2207U2250122, CB2207U2250121, CB2207U2250120, CB2207U2250119, CB2207U2250118, CB2207U2250117, CB2207U2250116, CB2207U2250115, CB2207U2250114, CB2207U2250113, CB2207U2250112, CB2207U2250111, CB2207U2250110, CB2207U2250109, CB2207U2250108, CB2207U2250107, CB2207U2250106, CB2207U2250105, CB2207U2250104, CB2207U2250103, CB2207U2250102, CB2207U2250101, CB2207U2250100, CB2207U2250099, CB2207U2250098, CB2207U2250097, CB2207U2250096, CB2207U2250095, CB2207U2250094, CB2207U2250093, CB2207U2250092, CB2207U2250091, CB2207U2250090, CB2207U2250089, CB2207U2250088, CB2207U2250087, CB2207U2250086, CB2207U2250085, CB2207U2250084, CB2207U2250083, CB2207U2250082, CB2207U2250081, CB2207U2250080, CB2207U2250079, CB2207U2250078, CB2207U2250077, CB2207U2250076, CB2207U2250075, CB2207U2250074, CB2207U2250073, CB2107U2250072, CB2107U2250071, CB2107U2250070, CB2107U2250069, CB2307U2250068, CB2307U2250067, CB2307U2250066, CB2307U2250065, CB2307U2250064, CB2307U2250063, CB2307U2250062, CB2307U2250061, CB2307U2250060, CB2307U2250059, CB2307U2250058, CB2307U2250057, CB2307U2250056, CB2307U2250055, CB2207U2250054, CB2207U2250053, CB2207U2250052, CB2207U2250051, CB2207U2250050, CB2207U2250049, CB2207U2250048, CB2207U2250047, CB2207U2250046, CB2207U2250045, CB2207U2250044, CB2207U2250043, CB2207U2250042, CB2207U2250041, CB2207U2250040, CB2207U2250039, CB2207U2250038, CB2207U2250037, CB2207U2250036, CB2207U2250035, CB2207U2250034, CB2207U2250033, CB2207U2250032, CB2207U2250031, CB2207U2250030, CB2207U2250029, CB2207U2250028, CB2207U2250027, CB2207U2250026, CB2207U2250025, CB2207U2250024, CB2207U2250023, CB2207U2250022, CB2207U2250021, CB2207U2250020, CB2207U2250019, CB2207U2250018, CB2207U2250017, CB2207U2250016, CB2207U2250015, CB2207U2250014, CB2207U2250013, CB2207U2250012, CB2207U2250011, CB2207U2250010, CB2207U2250009, CB2207U2250008, CB2207U2250007, CB2207U2250006, CB2207U2250005, CB2107U2250004, CB2107U2250003, CB2107U2250002, CB2107U2250001, CB2307U2230068, CB2307U2230067, CB2307U2230066, CB2307U2230065, CB2307U2230064, CB2307U2230063, CB2307U2230062, CB2307U2230061, CB2307U2230060, CB2307U2230059, CB2307U2230058, CB2307U2230057, CB2307U2230056, CB2307U2230055, CB2207U2230054, CB2207U2230053, CB2207U2230052, CB2207U2230051, CB2207U2230050, CB2207U2230049, CB2207U2230048, CB2207U2230047, CB2207U2230046, CB2207U2230045, CB2207U2230044, CB2207U2230043, CB2207U2230042, CB2207U2230041, CB2207U2230040, CB2207U2230039, CB2207U2230038, CB2207U2230037, CB2207U2230036, CB2207U2230035, CB2207U2230034, CB2207U2230033, CB2207U2230032, CB2207U2230031, CB2207U2230030, CB2207U2230029, CB2207U2230028, CB2207U2230027, CB2207U2230026, CB2207U2230025, CB2207U2230024, CB2207U2230023, CB2207U2230022, CB2207U2230021, CB2207U2230020, CB2207U2230019, CB2207U2230018, CB2207U2230017, CB2207U2230016, CB2207U2230015, CB2207U2230014, CB2207U2230013, CB2207U2230012, CB2207U2230011, CB2207U2230010, CB2207U2230009, CB2207U2230008, CB2207U2230007, CB2207U2230006, CB2207U2230005, CB2107U2230004, CB2107U2230003, CB2107U2230002, CB2107U2230001, CB2207U2210274, CB2207U2210273, CB2207U2210272, CB2207U2210271, CB2207U2210270, CB2207U2210269, CB2207U2210268, CB2207U2210267, CB2207U2210266, CB2207U2210265, CB2207U2210264, CB2207U2210263, CB2207U2210262, CB2207U2210261, CB2207U2210260, CB2207U2210259, CB2207U2210258, CB2207U2210257, CB2207U2210256, CB2207U2210255, CB2207U2210254, CB2207U2210253, CB2207U2210252, CB2207U2210251, CB2207U2210250, CB2207U2210249, CB2207U2210248, CB2207U2210247, CB2207U2210246, CB2207U2210245, CB2207U2210244, CB2207U2210243, CB2207U2210242, CB2207U2210241, CB2207U2210240, CB2207U2210239, CB2107U2210238, CB2107U2210237, CB2107U2210236, CB2107U2210235, CB2107U2210234, CB2107U2210233, CB2107U2210232, CB2107U2210231, CB2107U2210230, CB2107U2210229, CB2107U2210228, CB2107U2210227, CB2107U2210226, CB2107U2210225, CB2107U2210224, CB2107U2210223, CB2107U2210222, CB2107U2210221, CB2107U2210220, CB2107U2210219, CB2107U2210218, CB2107U2210217, CB2107U2210216, CB2107U2210215, CB2107U2210214, CB2107U2210213, CB2107U2210212, CB2107U2210211, CB2107U2210210, CB2107U2210209, CB2107U2210208, CB2107U2210207, CB2307U2210202, CB2307U2210201, CB2307U2210200, CB2307U2210199, CB2307U2210198, CB2307U2210197, CB2307U2210196, CB2307U2210195, CB2307U2210194, CB2307U2210193, CB2307U2210192, CB2307U2210191, CB2307U2210190, CB2307U2210189, CB2307U2210188, CB2307U2210187, CB2307U2210186, CB2307U2210185, CB2307U2210184, CB2307U2210183, CB2207U2210182, CB2207U2210181, CB2207U2210180, CB2207U2210179, CB2207U2210178, CB2207U2210177, CB2207U2210176, CB2307U2210175, CB2307U2210174, CB2307U2210173, CB2307U2210172, CB2307U2210171, CB2207U2210170, CB2207U2210169, CB2207U2210168, CB2207U2210167, CB2207U2210166, CB2207U2210165, CB2207U2210164, CB2207U2210163, CB2207U2210162, CB2207U2210161, CB2207U2210160, CB2207U2210159, CB2207U2210158, CB2207U2210157, CB2207U2210156, CB2207U2210155, CB2207U2210154, CB2207U2210153, CB2207U2210152, CB2207U2210151, CB2207U2210150, CB2207U2210149, CB2207U2210148, CB2207U2210147, CB2207U2210146, CB2207U2210145, CB2207U2210144, CB2207U2210143, CB2207U2210142, CB2207U2210141, CB2207U2210140, CB2207U2210139, CB2207U2210138, CB2207U2210137, CB2207U2210136, CB2207U2210135, CB2307U2210134, CB2307U2210133, CB2307U2210132, CB2307U2210131, CB2307U2210130, CB2307U2210129, CB2307U2210128, CB2307U2210127, CB2307U2210126, CB2307U2210125, CB2307U2210124, CB2307U2210123, CB2307U2210122, CB2307U2210121, CB2307U2210120, CB2307U2210119, CB2307U2210118, CB2307U2210117, CB2307U2210116, CB2307U2210115, CB2307U2210114, CB2307U2210113, CB2307U2210112, CB2307U2210111, CB2307U2210110, CB2207U2210109, CB2207U2210108, CB2207U2210107, CB2207U2210106, CB2207U2210105, CB2207U2210104, CB2207U2210103, CB2207U2210102, CB2207U2210101, CB2207U2210100, CB2207U2210099, CB2207U2210098, CB2207U2210097, CB2207U2210096, CB2207U2210095, CB2207U2210094, CB2207U2210093, CB2207U2210092, CB2207U2210091, CB2207U2210090, CB2207U2210089, CB2207U2210088, CB2207U2210087, CB2207U2210086, CB2207U2210085, CB2207U2210084, CB2207U2210083, CB2207U2210082, CB2207U2210081, CB2207U2210080, CB2207U2210079, CB2207U2210078, CB2207U2210077, CB2207U2210076, CB2207U2210075, CB2207U2210074, CB2207U2210073, CB2207U2210072, CB2207U2210071, CB2207U2210070, CB2207U2210069, CB2207U2210068, CB2207U2210067, CB2207U21C0206, CB2207U21C0205, CB2207U21C0204, CB2207U21C0203, CB2207U21C0202, CB2207U21C0201, CB2207U21C0200, CB2207U21C0199, CB2207U21C0198, CB2207U21C0197, CB2207U21C0196, CB2207U21C0195, CB2207U21C0194, CB2207U21C0193, CB2207U21C0192, CB2207U21C0191, CB2207U21C0190, CB2207U21C0189, CB2207U21C0188, CB2207U21C0187, CB2207U21C0186, CB2207U21C0185, CB2207U21C0184, CB2207U21C0183, CB2207U21C0182, CB2207U21C0181, CB2207U21C0180, CB2207U21C0179, CB2207U21C0178, CB2207U21C0177, CB2207U21C0176, CB2207U21C0175, CB2207U21C0174, CB2207U21C0173, CB2207U21C0172, CB2207U21C0171, CB2107U21C0170, CB2107U21C0169, CB2107U21C0168, CB2107U21C0167, CB2107U21C0166, CB2107U21C0165, CB2107U21C0164, CB2107U21C0163, CB2107U21C0162, CB2107U21C0161, CB2107U21C0160, CB2107U21C0159, CB2107U21C0158, CB2107U21C0157, CB2107U21C0156, CB2107U21C0155, CB2107U21C0154, CB2107U21C0153, CB2107U21C0152, CB2107U21C0151, CB2107U21C0150, CB2107U21C0149, CB2107U21C0148, CB2107U21C0147, CB2107U21C0146, CB2107U21C0145, CB2107U21C0144, CB2107U21C0143, CB2107U21C0142, CB2107U21C0141, CB2107U21C0140, CB2107U21C0139, CB2207U21C0136, CB2207U21C0135, CB2207U21C0134, CB2207U21C0133, CB2207U21C0132, CB2207U21C0131, CB2207U21C0130, CB2207U21C0129, CB2207U21C0128, CB2207U21C0127, CB2207U21C0126, CB2207U21C0125, CB2207U21C0124, CB2207U21C0123, CB2207U21C0122, CB2207U21C0121, CB2207U21C0120, CB2207U21C0119, CB2207U21C0118, CB2207U21C0117, CB2207U21C0116, CB2207U21C0115, CB2207U21C0114, CB2207U21C0113, CB2207U21C0112, CB2207U21C0111, CB2207U21C0110, CB2207U21C0109, CB2207U21C0108, CB2207U21C0107, CB2207U21C0106, CB2207U21C0105, CB2207U21C0104, CB2207U21C0103, CB2207U21C0102, CB2207U21C0101, CB2207U21C0100, CB2107U21C0099, CB2107U21C0098, CB2107U21C0097, CB2107U21C0096, CB2107U21C0095, CB2107U21C0094, CB2107U21C0093, CB2107U21C0092, CB2107U21C0091, CB2107U21C0090, CB2107U21C0089, CB2107U21C0088, CB2107U21C0087, CB2107U21C0086, CB2107U21C0085, CB2107U21C0084, CB2107U21C0083, CB2107U21C0082, CB2107U21C0081, CB2107U21C0080, CB2107U21C0079, CB2107U21C0078, CB2107U21C0077, CB2107U21C0076, CB2107U21C0075, CB2107U21C0074, CB2107U21C0073, CB2107U21C0072, CB2107U21C0071, CB2107U21C0070, CB2107U21C0069, CB2107U21C0068, CB2107U21C0067, CB2107U21C0066, CB2107U21C0065, 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CB2207U21C0002, CB2207U21C0001, CB2207U21BT000, CB2207U21B0000, CA2201U21A0204, CA2201U21A0203, CA2201U21A0202, CA2201U21A0201, CA2201U21A0200, CA2201U21A0199, CA2201U21A0198, CA2201U21A0197, CA2201U21A0196, CA2201U21A0195, CA2201U21A0194, CA2201U21A0193, CA2201U21A0192, CA2201U21A0191, CA2201U21A0190, CA2201U21A0189, CA2201U21A0188, CA2201U21A0187, CA2201U21A0186, CA2201U21A0185, CA2201U21A0184, CA2201U21A0183, CA2201U21A0182, CA2201U21A0181, CA2201U21A0180, CA2201U21A0179, CA2201U21A0178, CA2201U21A0177, CA2201U21A0176, CA2201U21A0175, CA2201U21A0174, CA2201U21A0173, CA2201U21A0172, CA2201U21A0171, CA2201U21A0170, CA2201U21A0169, CA2201U21A0168, CA2201U21A0167, CA2201U21A0166, CA2201U21A0165, CA2101U21A0164, CA2101U21A0163, CA2101U21A0162, CA2101U21A0161, CA2101U21A0160, CA2101U21A0159, CA2101U21A0158, CA2101U21A0157, CA2101U21A0156, CA2101U21A0155, CA2101U21A0154, CA2101U21A0153, CA2101U21A0152, CA2101U21A0151, CA2101U21A0150, CA2101U21A0149, CA2101U21A0148, CA2101U21A0147, 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CA2201U2120158, CA2201U2120157, CA2201U2120156, CA2201U2120155, CA2201U2120154, CA2201U2120153, CA2201U2120152, CA2201U2120151, CA2201U2120150, CA2201U2120149, CA2201U2120148, CA2201U2120147, CA2101U2120146, CA2101U2120145, CA2101U2120144, CA2101U2120143, CA2101U2120142, CA2101U2120141, CA2101U2120140, CA2101U2120139, CA2101U2120138, CA2101U2120137, CA2101U2120136, CA2101U2120135, CA2101U2120134, CA2101U2120133, CA2301U2110468, CA2301U2110467, CA2301U2110466, CA2301U2110465, CA2301U2110464, CA2301U2110463, CA2301U2110462, CA2301U2110461, CA2301U2110460, CA2301U2110459, CA2301U2110458, CA2301U2110457, CA2301U2110456, CA2301U2110455, CA2301U2110454, CA2301U2110453, CA2301U2110452, CA2301U2110451, CA2301U2110450, CA2201U2110449, CA2201U2110448, CA2201U2110447, CA2201U2110446, CA2201U2110445, CA2201U2110444, CA2201U2110443, CA2201U2110442, CA2201U2110441, CA2201U2110440, CA2201U2110439, CA2201U2110438, CA2201U2110437, CA2201U2110436, CA2201U2110435, CA2201U2110434, CA2201U2110433, CA2201U2110432, CA2201U2110431, CA2201U2110430, CA2201U2110429, CA2201U2110428, CA2201U2110427, CA2201U2110426, CA2201U2110425, CA2201U2110424, CA2201U2110423, CA2201U2110422, CA2201U2110421, CA2201U2110420, CA2201U2110419, CA2201U2110418, CA2201U2110417, CA2201U2110416, CA2201U2110415, CA2101U2110414, CA2101U2110413, CA2101U2110412, CA2101U2110411, CA2101U2110410, CA2101U2110409, CA2101U2110408, CA2101U2110407, CA2101U2110406, CA2101U2110405, CA2101U2110404, CA2101U2110403, CA2101U2110402, CA2101U2110401.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1826-2026%22", "url": "https://recallledger.net/recalls/device-z-1826-2026-whill-model-c2-with-software-versions-before-hmi-2-22-mc-1-13-de/"}, {"id": "fda-food-h-0667-2026", "source": "FDA", "category": "food", "recall_number": "H-0667-2026", "title": "CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton recall (Mondelez Global Llc)", "product": "CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch )  and 7.7 oz Carton ( 1.4 oz pouch)", "reason": "Hard corn starch lumps were found in the product", "hazard_level": "Class II", "company": "Mondelez Global Llc", "company_location": "East Hanover, NJ, United States", "date": "2025-12-30", "report_date": "2026-04-29", "status": "Completed", "distribution": "The product was distributed to the following States : MN, PA, OH,IL, IN,TN,KY,FL,NC,TN,WI, VA", "states": ["FL", "IL", "IN", "KY", "MN", "NC", "OH", "PA", "TN", "VA", "WI"], "nationwide": false, "quantity": "437 Cases", "codes": "Case/UPC 1 00 44000 08667 8  Best When Used By Dates 09MAY2026 10MAY2026 11MAY2026 12MAY2026  Case/UPC 1 00 44000 08565 7  Best When Used By Dates  12MAY2026 18MAY2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0667-2026%22", "url": "https://recallledger.net/recalls/food-h-0667-2026-chips-ahoy-baked-bites-brookie-22-4-oz-carton-2-8-oz-pouch-and/"}, {"id": "fda-device-z-1701-2026", "source": "FDA", "category": "device", "recall_number": "Z-1701-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument  Product Name: da Vinci S, Si Permanent Cautery Hook Instrument  Model/Catalog Number: 420183  Software Version: NA  Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: NA", "reason": "Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.", "states": ["AR", "CA", "CT", "FL", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MN", "MO", "MS", "NC", "NJ", "NM", "NY", "OH", "PA", "TX", "VA", "WA"], "nationwide": true, "quantity": "6152 instruments", "codes": "Lot Code: 420183, Permanent Cautery Hook GTIN:  00886874111536 FDA Medical Device Listing Number:  D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294  Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182  Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076  Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935  Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604  Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997  Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997  Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997  Material Numbers: 420183-16 da Vinci System Number: SH1997", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2026%22", "url": "https://recallledger.net/recalls/device-z-1701-2026-brand-name-da-vinci-s-si-permanent-cautery-hook-instrument-product/"}, {"id": "fda-device-z-1700-2026", "source": "FDA", "category": "device", "recall_number": "Z-1700-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Tenaculum Forceps Instrument  Product Name: da Vinci S, Si Tenaculum Forceps Instrument  Model/Catalog Number: 420207  Software Version: N/A  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: N/A", "reason": "Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.", "states": ["AR", "CA", "CT", "FL", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "MN", "MO", "MS", "NC", "NJ", "NM", "NY", "OH", "PA", "TX", "VA", "WA"], "nationwide": true, "quantity": "2095 instruments", "codes": "Lot Code: 420207: Tenaculum Forceps Instrument GTIN: 00886874111659 FDA Medical Device Number: D088920  Material Number: 420207-06 da Vinci System Numbers: SH1378 SH0935 SH0935 SH0935 USG294 SH0761 SH0729 SH1182 SH1378 USG022 SH1378 SH1368 SH0059 SH1015 SH1182 SH0825 USG294 SH1390 USG022 SH0495 SH0495 SH1076 SH1390 SH1390 SH1390 SH1276 SH1385 USG022 SH0547 SH1385 SH1391 SH2144 SH0059 SH1279 SH0059 SH1390 SH1570 SH0059 SH1391 SG704 SH1570 SH0729 SH1385 SH1378 USG518 SH1385 SH1837 USG294 SH1368 SH1390 SH1385 SH1368 SG2026 SH1557 SH2144 SH1385 USG518 SH1279 USG294 SH1391  Material Number: 420207-07 da Vinci System Numbers: SH1391 SH1385 SH1385 SH1279 SH2125 SH0729 SH1368 USG721 SH1385 SH1997 SH2125 USG294 SH1378 SH1997 SH0035 SG704 SH1385 SH1279 SH1279 SH2125 SH1378 SH1378 SH0495 SH1390 SH1390 SH1385 SH2125 SH1378 SH1385 SH1279 USG721 SH1279 SH1837 USG518 SH1385 SH1378 USG022 SH1378 SH1570 SH1385 SH1385 SH0935 SH0935 SG704 SG704 SH1378 USG022 SH1385 SH1279 USG721 SH1279 USG518 SH1837 SH1279 USG022 SH1385 SH1385 SH1964 SH1385 SH1390 SH1279 SH1964 SH1385 SH1570 USG294 SH1182 SH1279 SH1279 USG022 SH1385 SH0825 USG294 SH0035 SH1276 SH2125 SH1279 RSH0152 USG518 SH1557 SH1837 SH1385 SH1390 SH1279 SH1390 SH1390 USG294 SH1385 SH1279 SH1385 SH1279 SH2125 USG721 SH1837 SH0035 SH1964 SH1837 SH1385 SH1385 SH1279 SH1279 RSH0152 SH1378 SH0495  Material Number: 420207-09 da Vinci System Numbers: RSH0152 SH1378 SH1385 SH1279 USG721 SH1279 SH1378 SH1385 USG721 SH1279 SH1182 SH1390 SH1076 USG721 SH1279 SH1182 SH1385 SH1837 SH1279 SH1837 SH1279  Material Number: 420207-10 da Vinci System Numbers: SH1279 SH1385 SH1390 SH1279 SH1385 SH1182 SH1368 SH1997 SH1279 USG721 SH1822 SH1557 SH1822 SH1964 SH1279 SH0495 SH1390 SH1279 SH1964 USG022 SH1822 SH1378 SH1182 SH1837 SH1279 SH1279 SH1279 SH1279 SH1997 SH1964 SH1964 SH1997 SH0761 SH1279 SH1837 SH1279 SH1279 SH1279 SH1390 SH1279 SH1997", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1700-2026%22", "url": "https://recallledger.net/recalls/device-z-1700-2026-brand-name-da-vinci-s-si-tenaculum-forceps-instrument-product-name/"}, {"id": "fda-device-z-1699-2026", "source": "FDA", "category": "device", "recall_number": "Z-1699-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  Software Version: NA  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: NA", "reason": "Due to increased complaints for broken/frayed grip cables for reusable instruments.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.", "states": ["CA", "FL", "GA", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MO", "MS", "NC", "NJ", "NY", "OH", "PA", "TX", "VA", "WI"], "nationwide": true, "quantity": "2660", "codes": "Lot Code: 420278: Grasping Retractor GTIN:  00886874111772 FDA Medical Device Listing Number:  D088920  Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761  Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385  Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604  Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2026%22", "url": "https://recallledger.net/recalls/device-z-1699-2026-brand-name-da-vinci-s-si-grasping-retractor-instrument-product-name/"}, {"id": "fda-device-z-1698-2026", "source": "FDA", "category": "device", "recall_number": "Z-1698-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Mega Needle Driver Instrument  Product Name: da Vinci S, Si Mega Needle Driver Instrument  Model/Catalog Number: 420194  Software Version: NA  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: NA", "reason": "Due to increased complaints for broken/frayed grip cables for reusable instruments.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.", "states": ["CA", "FL", "GA", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MO", "MS", "NC", "NJ", "NY", "OH", "PA", "TX", "VA", "WI"], "nationwide": true, "quantity": "7819", "codes": "Lot Code: 420194, Mega Needle Driver GTIN:  00886874111611 FDA Medical Device Listing Number:  D088920  Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M10120217 SH0729 M10120301 SH0729 M10120412 SH0729 M10120507 SH0729 M10120525 SH0729 M20120530 SH0729 M10120703 SH0729 M10120724 SH0729 M10120803 SH0729 M10120810 SH0729 M10120827 SH0729 M10121025 SH0729 M10130102 SH0729 M10130212 SH0729 M10130213 SH0729 M10130314 SH0729 M10130418 SH0729 M10130517 SH0729 M10130603 SH0729 M10130606 SH0729 M10130617 SH0729 M10130701 SH0729 M10131014 SH0729 N10140430 SH0729 M10101206 SH0035 M10110624 SH0035 M10101206 SH1391 S10110307 SH1391 M10110302 SH1391 M10110701 SH1391 M10120404 SH1391 M10120705 SH1391 M10121010 SH1391 M10130118 SH1391 M10130125 SH1391 M10130515 SH1391 M10130626 SH1391 M10121206 SH1604 M10130308 SH1604 M10101127 SH0495 M10101217 SH0495 M10110131 SH0495 M10110512 SH0495 M10110817 SH0495 M10110901 SH0495 M10111008 SH0495 M20111221 SH0495 M10120217 SH0495 M10120224 SH0495 M10110527 SH0495 M10120727 SH0495 M10121004 SH0495 M10130102 SH0495 M10130213 SH0495 M10130301 SH0495 M10130812 SH0495 M10130924 SH0495 M10111201 SH1015 M10111208 SH1015 M10120217 SH1015 M10120425 SH1015 M10120618 SH1015 M10120713 SH1015 M10120823 SH1015 M10120827 SH1015 M10121022 SH1015 M10130212 SH1015 M10130213 SH1015 M10130828 SH1015 M10120831 SH1385 M10120918 SH1385 M10110412 SH2144 M10110706 SH2144 M10110923 SH2144 M10111008 SH2144 M10111205 SH2144 M20120103 SH2144 M10120210 SH2144 M10120713 SH2144 M10121121 SH2144 M10130325 SH2144 M10130529 SH2144 M10110302 SH0761 M10121129 SH0761 M10130719 SH0761 M10131001 SH0761 M20120322 SH1276 M10120525 SH1276 M10130503 USG518 M10130821 USG518 M10130828 USG518 M10131014 USG518  Material Number: 420194-10 Batch / System Numbers:  N10170714 SH1182 N10170817 SH1182 N10171019 SH1182 M10140303 SH1570 N10140805 SH1570 N10150702 SH1570 N10160311 SH1570 N10160421 SH1570 N10161206 SH1570 N10161223 SH1570 N10180227 SG704 M10131121 SH0547 N10140609 SH0547 M10140221 SH0059 M10140307 SH0059 N10140508 SH0059 N10140827 SH0059 N10150320 SH0059 N10160519 SH0059 N10160728 SH0059 N11160907 SH0059 N11161013 SH0059 N10161129 SH0059 N10170419 SH0059 N11170407 SH0059 N10170612 SH0059 N10170705 SH0059 N10180202 SH0059 N10180323 SH0059 N10180321 SH0059 N10180412 SH0059 M10140225 SH1557 N10140605 SH1557 N10140620 SH1557 N10140827 SH1557 N12140929 SH1557 N10150211 SH1557 N10150320 SH1557 N10150528 SH1557 N10150616 SH1557 N10150721 SH1557 N10151209 SH1557 N10160307 SH1557 N10160519 SH1557 N10160509 SH1557 N10160728 SH1557 N10160907 SH1557 N10161031 SH1557 N11170111 SH1557 N11161216 SH1557 N11170427 SH1557 N10170504 SH1557 N10170605 SH1557 N10170914 SH1557 N10171016 SH1557 N10171027 SH1557 N10180118 SH1557 N10180223 SH1557 N10180321 SH1557 N10180427 SH1557 N10150604 SH1964 N10150626 SH1964 N10151207 SH1964 N10151211 SH1964 N10180131 SH1964 N10180223 SH1964 N10180404 SH1964 N10180426 SH1964 N10150814 SH1837 N10160105 SH1837 N10160728 SH1837 N11160901 SH1837 N10150717 SH1390 N10160419 SH1390 M10131211 USG689 N10160519 USG689 M10140515 SH1368 N11141113 SH1368 N10160105 SH1368 N10160718 SH1368 N10170901 SH1368 M10131102 USG294 M10140107 USG294 M10140109 USG294 M10140221 USG294 M10140408 USG294 N10140516 USG294 N10140923 USG294 N10141016 USG294 N10150219 USG294 N10150325 USG294 N10150723 USG294 N10151002 USG294 N10151013 USG294 N10160104 USG294 N10160307 USG294 N10160504 USG294 N11160616 USG294 N11160720 USG294 N10160907 USG294 N11160923 USG294 N10161118 USG294 N10161207 USG294 N10170302 USG294 N10170421 USG294 N10170621 USG294 N10170817 USG294 N10170927 USG294 N10180202 USG294 N10171214 USG294 N10180131 USG294 M10140324 SH2186 N10141127 SH2186 N10150320 SH2186 N10150626 SH2186 N10150731 SH2186 N10160901 SH2186 N10170427 SH2186 N10170509 SH2186 N10171221 SH2186 N10180321 SH2186 N11161207 SH0825 N10170511 SH0825 N10180301 SH0825 M10131109 SH1378 M10131104 SH0935 M10140225 SH0935 N10140718 SH0935 M10131109 SH0729 M10131130 SH0729 M10131202 SH0729 M10140107 SH0729 N10140611 SH0729 N10140716 SH0729 N10140717 SH0729 N10140728 SH0729 N10140826 SH0729 N11140929 SH0729 N10141118 SH0729 N10141205 SH0729 N10150219 SH0729 N10150226 SH0729 N10150421 SH0729 N10150428 SH0729 N10150721 SH0729 N10150804 SH0729 N10151123 SH0729 N10151203 SH0729 N10160311 SH0729 N11160419 SH0729 N11160907 SH0729 N10161019 SH0729 N10170324 SH0729 N11170410 SH0729 N10170511 SH0729 N10170621 SH0729 N10170810 SH0729 N10171207 SH0729 N10180202 SH0729 N11171214 SH0729 N11180321 SH0729 N10180307 SH0729 N10180412 SH0729 N10140722 SH0035 N10140910 SH0035 N10150519 SH0035 N10150707 SH0035 N11160711 SH0035 N10160804 SH0035 N10170207 SH0035 N10170511 SH0035 N10171207 SH0035 M10131121 SH1391 M10131217 SH1391 N10140516 SH1391 M10140206 SH2125 N10140530 SH2125 N10140611 SH2125 N10140926 SH2125 N10150105 SH2125 N10150413 SH2125 N10150504 SH2125 N10150804 SH2125 N10150918 SH2125 N10150928 SH2125 N10160114 SH2125 N10160504 SH2125 N10160519 SH2125 N10160601 SH2125 N10161019 SH2125 N10161216 SH2125 N10170404 SH2125 N10161025 SH2125 M10131104 SH2125 N10170712 SH2125 N10171103 SH2125 N11171214 SH2125 N10180223 SH2125 N10150818 SH2125 N10180323 SH2125 N10180321 SH2125 N10180427 SH2125 N10160219 SH1076 N10170427 SH1076 M10140116 SH1604 N10170926 SH1604 N10180122 SH1604 N10180111 SH1604 M10140121 SH0495 M10140303 SH0495 N10140522 SH0495 N10140808 SH0495 N11141112 SH0495 N10141127 SH0495 N11141205 SH0495 N10150226 SH0495 N10150626 SH0495 N10150811 SH0495 N10160523 SH0495 N10160822 SH0495 N11160822 SH0495 N10161118 SH0495 N10170301 SH0495 N10170927 SH0495 N10180202 SH0495 M10131119 SH1015 M11140109 SH1015 M10140131 SH1015 M10140307 SH1015 N10140425 SH1015 N10140708 SH1015 N10140904 SH1015 N11140902 SH1015 N10150204 SH1015 N10150211 SH1015 N10150216 SH1015 N10150511 SH1015 N10150610 SH1015 N10150630 SH1015 N10150707 SH1015 N10150828 SH1015 N10150916 SH1015 N10150928 SH1015 N10160212 SH1015 N10160229 SH1015 N10160307 SH1015 N10160330 SH1015 N10160504 SH1015 N10160610 SH1015 N10160616 SH1015 N10160630 SH1015 N10160706 SH1015 N11160711 SH1015 N10160822 SH1015 N11160907 SH1015 N10160901 SH1015 N11161013 SH1015 N11161118 SH1015 N10161118 SH1015 N10161223 SH1015 N10170202 SH1015 N10170302 SH1015 N10170316 SH1015 N11170324 SH1015 N10170331 SH1015 N10170504 SH1015 N10170511 SH1015 N10170515 SH1015 N10170623 SH1015 N10170710 SH1015 N10170720 SH1015 N10170901 SH1015 N10171003 SH1015 N10171103 SH1015 N10180312 SH1015 N10171221 SH1015 N10180122 SH1015 N10171226 SH1015 N10180124 SH1015 N10180227 SH1015 N10180426 SH1015 N10180412 SH1385 M10140303 SH2144 M10140326 SH2144 N10140605 SH2144 N10140805 SH2144 N10150223 SH2144 N10160519 SH2144 N10170913 SH2144 N10150312 SH0761 N10150528 SH0761 M10140206 SH1276 M10140213 SH1276 M10140327 SH1276 N10140508 SH1276 N10140925 SH1276 N10150305 SH1276 N10151021 SH1276 N10151125 SH1276 N10140902 USG518 N12140929 USG518 N10141008 USG518 M10140108 USG518 N10150320 USG518 N10161111 USG518 N10170103 USG518  Material Number: 420194-12 Batch / System Numbers: N10190729 SH1182 N10180921 SH1557 N10190104 SH1557 N10190211 SH1557 N10190326 SH1557 N12190423 SH1557 N10190719 SH1557 N11191021 SH1557 N10191216 SH1557 N10210329 SH1557 N10210524 SH1557 N10210517 SH1557 N10190108 SH1837 N10200727 SH1837 N10201012 SH1837 N10201103 SH1837 N10210412 SH1837 N10191111 USG689 N10191125 USG689 N10190805 SH1368 N10190930 SH1368 N10180808 USG294 N10180906 SH2186 N10190522 SH2186 N10201012 SH2186 N10190226 SH0825 N10190326 SH0825 N10210412 SH0825 N10181126 SH0729 N10190107 SH0729 N10190212 SH0729 N10180814 SH2125 N10180815 SH2125 N10181008 SH2125 N10190107 SH2125 N10190212 SH2125 N10190327 SH2125 N10190729 SH2125 N10191111 SH1076 N10180808 SH1604 N10190930 SH1604 N10190108 SH0495 N10190805 SH0495 N10190930 SH0495 N10200727 SH0495 N10180814 SH1015 N10180813 SH1015 N10181017 SH1015 N10190107 SH1015 N10190108 SH1015 N10190307 SH1015 N10190308 SH1015 N10190522 SH1015 N10190805 SH1015 N10190923 SH1015 N10190917 SH1015 N10191111 SH1015 N11191202 SH1015 N10191216 SH1015 N10191125 SH1015 N10191021 SH1015 N10200810 SH1015 N10201103 SH1015 N10210802 SH1015 N10181024 SH1385 N10191111 SH1385 N10190107 SH1279 N10190212 SH1279 N10190327 SH1279 N10210607 SH1279  Material Number: 420194-13 Batch / System Numbers: K11220626 SH1964 K10220228 SH1837", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2026%22", "url": "https://recallledger.net/recalls/device-z-1698-2026-brand-name-da-vinci-s-si-mega-needle-driver-instrument-product-name/"}, {"id": "fda-device-z-1697-2026", "source": "FDA", "category": "device", "recall_number": "Z-1697-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument  Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument  Model/Catalog Number: 420189  Software Version: NA  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: NA", "reason": "Due to increased complaints for broken/frayed grip cables for reusable instruments.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.", "states": ["CA", "FL", "GA", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MO", "MS", "NC", "NJ", "NY", "OH", "PA", "TX", "VA", "WI"], "nationwide": true, "quantity": "2370", "codes": "Lot Code: 420189, Double Fenestrated Grasper GTIN:  00886874111581 FDA Medical Device Listing Number:  D088920  Material Number: 420189-07 Batch / System Numbers: M10120911 SH1182 M10130103 SH1182 M10130116 SH1182 M10130124 SH1182 M10130422 SH1182 M10130731 SH1182 M10130918 SH1182 M10110112 SG704 M10110202 SG704 M10110318 SG704 M10111028 SG704 M20111221 SG704 M10120220 SG704 M10120419 SG704 M10130110 SG704 M10130422 SG704 M10130726 SG704 M10130802 SG704 M10130802 SH0547 M10130918 SH0547 M10110808 SH0059 M10111027 SH0059 M10111104 SH0059 M10121123 SH0059 M10121213 SH0059 M10130103 SH0059 M10130815 SH1557 M10130625 SH1390 M10130731 SH1390 M10130802 SH1390 M10130603 USG721 M10120911 SH0825 M10120727 SH1378 M10121026 SH1378 M10121105 SH1378 M10130121 SH1378 M10130207 SH1378 M10130218 SH1378 M10130322 SH1378 M10130315 SH1378 M10130422 SH1378 M10130603 SH1378 M10130625 SH1378 M10130726 SH1378 M10131010 SH1378 M10110309 SH0729 M10110415 SH0729 M10110621 SH0729 M10110812 SH0729 M10121009 SH0729 M10130103 SH0729 M10130124 SH1622 M10120125 SH1076 M10121113 SH1076 M10130426 SH1604 M10120719 SH1385 M10120727 SH1385 M10120822 SH1385 M10120829 SH2144 M10111104 SH0761 M10120327 SH1276 M10120522 SH1276 M10121026 SH1276 M10130514 SH1276 M10130426 USG518 M10130829 USG518  Material Number: 420189-09 Batch / System Numbers: M10131104 SH1182 M10140228 SH1182 M10140414 SH1182 N10140508 SH1182 N10140619 SH1182 N10140703 SH1182 N10140812 SH1182 N10140902 SH1182 N10141204 SH1182 N10150430 SH1182 N10150814 SH1182 N10150916 SH1182 N10151106 SH1182 N10151119 SH1182 N10160429 SH1182 N10160520 SH1182 N10150825 SH1182 N10160617 SH1182 N10160914 SH1182 N10161012 SH1182 N10161222 SH1182 N10160908 SH1182 N10180105 SH1182 N10140521 SG704 N10140801 SG704 N10141017 SG704 N10150309 SG704 N10150526 SG704 N10150805 SG704 N10160106 SG704 N10160429 SG704 N10160425 SG704 N10160901 SG704 N10170330 SG704 N10171116 SG704 N10171121 SG704 N10150219 SH0547 N10160408 SH0547 M10140324 SH0059 N10140902 SH0059 N10141121 SH0059 N10150227 SH0059 N10150409 SH0059 N10150626 SH0059 N10160901 SH0059 N10160914 SH0059 N10161012 SH0059 N10161122 SH0059 N10171212 SH0059 N10150416 SH1557 N10150727 SH1557 N10160229 SH1557 N10151201 SH1557 N10160520 SH1557 N10160817 SH1557 N10161012 SH1557 N10161122 SH1557 N10170130 SH1557 N10170210 SH1557 N10160825 SH1557 N10170515 SH1557 N10170815 SH1557 N10171116 SH1557 N10171121 SH1557 N10180105 SH1557 M10131108 SH1390 N10141017 SH1390 N10170825 SH1368 N10160525 USG721 N10160808 USG721 M10140327 SH2186 N10140902 SH0825 N10141027 SH0825 N10160114 SH0825 N10161027 SH0825 N10171116 SH0825 M10131025 SH1378 M10131104 SH1378 M10140214 SH1378 M10140324 SH1378 N10140508 SH1378 N10140902 SH1378 N10141030 SH1378 N10141204 SH1378 N10160203 SH1378 N10170330 SH1378 M10140325 SH0729 N10140711 SH0729 N10150122 SH0729 N10150910 SH0729 N10151217 SH0729 N10160509 SH0729 N10160216 SH0035 N10170609 SH0035 M10140327 SH2125 N10140603 SH2125 N10160718 SH2125 N10161209 SH2125 N10171019 SH1604 N10171220 SH1604 N10170531 SH1279 N10170609 SH1279 N10170628 SH1279 N10140711 SH2144 N10150129 SH2144 N10150526 SH2144 N10150727 SH2144 N10151119 SH2144 N10160914 SH2144 N10161222 SH2144 N10171204 SH2144 M10140414 SH1276 N10140603 SH1276 N10150129 USG518  Material Number: 420189-10 Batch / System Numbers: N10180409 SH1182 N10180702 SH1182 N10180509 SG704 N10180223 SH1557 N10180712 SH1557 N12180123 SH0825 N10180409 SH1279  Material Number: 420189-11 Batch / System Numbers: N10190128 SH1182 N10190206 SH1182 N10180814 SH1557 N10181005 SH1557 N10180802 SH1557 N10180928 SH1557 N10190423 SH1557 N10190902 SH1557 N10180814 SH0825 N10190805 SH0825 N10190306 SH2180 N10190128 SH1604 N10180814 SH2144  Material Number: 420189-12 Batch / System Numbers: N10190715 SH1182 N10190502 SH1182 N10190513 SH1182 N10190513 SH1557 N10190408 SH1557 N10190715 SH1557 N10200217 SH1557 N10200803 SH1557 N10201005 SH1557 N10210419 SH1557 N10210210 SH1557 N10200217 SH1964 N10200720 SH1964 N10200427 SH1964 N10210419 SH1964 N10210308 SH1964 N10210713 SH1964 N10200427 SH1604 N10210104 SH1604 N10190502 SH1385 N10210913 SH2144 K10220925 SH2144 K10231026 SH2144", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2026%22", "url": "https://recallledger.net/recalls/device-z-1697-2026-brand-name-da-vinci-s-si-double-fenestrated-grasper-instrument-prod/"}, {"id": "fda-device-z-1696-2026", "source": "FDA", "category": "device", "recall_number": "Z-1696-2026", "title": "Brand Name: da Vinci S recall (Intuitive Surgical, Inc.)", "product": "Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument  Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument  Model/Catalog Number: 420179  Software Version: N/A  Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.    All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).  Component: N/A", "reason": "Due to increased complaints for broken/frayed grip cables for reusable instruments.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-09", "report_date": "2026-04-08", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. 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SH0495 M10121126 SH0935 M10121128 SH0059 M10121128 SH0729 M10121129 SH1276 M10121204 USG022 M10121205 SH2144 M10121206 SH0059 M10121215 SH1378 M10121215 SH1391 M10121215 SH0495 M10121218 USG294 M10121219 SH0547 M10130102 SH0547 M10130102 SH0059 M10130102 SH1279 M10130104 USG294 M10130108 SH1390 M10130108 USG022 M10130108 SH1279 M10130109 SH1368 M10130110 SH1368 M10130110 SH0935 M10130114 SH0729 M10130115 USG294 M10130116 SH1570 M10130116 SH0935 M10130117 SH0059 M10130117 SH0825 M10130117 SH0729 M10130117 SH0495 M10130118 USG294 M10130121 SH1390 M10130122 USG721 M10130122 SH1015 M10130123 SH1182 M10130124 SH1378 M10130124 SH0761 M10130205 USG022 M10130207 SH1391 M10130207 SH1015 M10130208 SG704 M10130211 USG689 M10130212 SH0729 M10130212 SH0761 M10130213 SH0547 M10130214 SH0729 M10130214 SH0495 M10130215 SH1182 M10130215 SH1378 M10130222 SH1390 M10130227 SH0495 M10130228 SH1622 M10130304 SH0825 M10130304 SH0495 M10130305 SH1570 M10130306 SH0761 M10130306 SH1276 M10130307 USG294 M10130308 SG2026 M10130308 SH1378 M10130308 SH1279 M10130313 USG294 M10130313 SH0935 M10130315 SH2144 M10130315 SH0761 M10130318 SH0059 M10130319 SH1279 M10130319 SH2144 M10130322 SH1279 M10130402 USG022 M10130404 USG022 M10130408 SH1378 M10130408 SH0729 M10130409 SH0059 M10130409 SH0761 M11110225 SG704 M11110323 SH1368 M11110517 SH0729 M11110517 SH1279 M11110517 SH2144 M11110525 SH0761 M11110526 SG704 M11110531 SH0495 M11110602 USG294 M11110602 SH0729 M11110623 SH1368 M11110623 SH1279 M11110625 SH0547 M11110625 USG294 M11110630 SG704 M11110630 USG294 M11110701 USG721 M11110701 SH0495 M11110701 SH0761 M11110808 SH0495 M11110808 SH0761 M11110809 USG294 M11110809 SH1391 M11110809 SH2144 M11110810 SH0761 M11110825 SH0059 M11110825 SH0761 M11110826 SH2144 M11110929 SG2026 M11110929 SH1279 M11111026 SH0729 M11111027 USG294 M11111028 SH0935 M11111028 SH0495 M11111117 USG022 M11111117 SH0729 M11111117 SH0761 M11111124 SH1015 M11111129 USG721 M11111130 USG294 M11111130 SH2144 M11120103 SH0059 M11120103 SH0729 M11120116 USG294 M11120116 SH0495 M11120126 SH0035 M11120127 SH1279 M11120130 USG294 M11120131 SH1182 M11120208 USG294 M11120209 SH0761 M11120210 SH0935 M11120213 SH0729 M11120214 SG2026 M11120330 USG294 M11120402 SH1391 M11120403 USG022 M11120404 SH1279 M11120517 USG294 M11120517 SH1279 M11120522 SH1368 M11120522 SH1276 M11120607 USG294 M11120607 USG022 M11120608 USG022 M11120717 USG294 M11120801 SH1015 M11120813 SH1368 M11120814 SH0729 M11120814 SH1276 M11120816 SH0729 M11120821 USG294 M11120906 SH1378 M11120919 USG689 M11120928 SH0935 M11120928 SH1276 M11121004 USG294 M11121004 SH1015 M11121004 SH1279 M11121010 USG294 M11121011 SH1182 M11121015 SH1378 M11121016 SH2144 M11121114 SH1557 M11121114 SH1378 M11121114 SH0935 M11121114 SH1279 M11121114 SH1276 M11121115 SH1076 M11121116 SH1279 M11121129 USG294 M11121129 SH0761 M11121130 SH0059 M11121203 USG294 M11121205 SH0035 M11121206 SH1604 M11121206 SH1385 M11121211 SG704 M11121211 SH0935 M11121211 SH2144 M11121214 SH1622 M11121218 SH0495 M11121219 SH1279 M11130112 USG294 M11130121 SH1276 M11130124 USG294 M11130124 SH0729 M11130124 SH1279 M11130207 USG721 M11130211 SH1378 M11130213 USG294 M11130214 SH2144 M11130225 SH0729 M11130226 USG721 M11130227 SH0059 M11130227 USG294 M11130228 SH0729 M11130301 SG704 M11130306 SH0059 M11130307 SH1378 M11130315 SH1378 M11130315 SH1391 M11130315 SH1015 M11130322 SH0729 M11130322 SH1276 M11130402 SH1279 M11130404 SH1015 M12110228 SH1279 M12120614 USG294 M12120614 SH1378 M12120801 SH1378 M12120816 SH1279 M12120906 SH1279 M12121011 SH1276 M12121105 SH0495 M12121207 SH1368 M12121211 SH0729 M12130109 SH0495 M12130111 SG704 M12130213 SH1279 M12130221 USG721 M12130226 SH0729 M12130226 SH0035 M12130320 USG294 M12130320 SH0935 M12130320 SH2144 M13120801 SH1390 M13120801 SH0495 M13121206 SH1378 M13130110 USG294 M13130110 SH0761 M13130111 USG721 M13130111 SH0935 M13130112 SH0035 M20111026 SH0935 M20111118 USG294 M20111206 SH0935 M20111206 SH1279 M20120116 USG294 M20120116 SH2144 M20120125 SH1391 M20120125 SH1076 M20120306 SH0495 M20120307 SH0935 M20120307 SH1279 M20120308 SH0035 M20120314 USG294 M20120314 SH0495 M20120514 USG721 M20120514 SH0825 M20120514 SH0729 M20120514 SH1276 S12110708 USG294  Material Number: 420179-12 Batch /  System Numbers: M10130601 SH1390 M10130603 SH0825 M10130603 SH0495 M10130605 USG022 M10130605 SH2144 M10130606 SH1570 M10130611 SH1390 M10130612 SH2144 M10130612 SH1276 M10130614 SH0935 M10130619 SG704 M10130620 SH1378 M10130621 SH0729 M10130622 SH1276 M10130703 SH1182 M10130703 SH0035 M10130704 SH2144 M10130710 SH1378 M10130713 SH0729 M10130713 SH1385 M10130713 SH0761 M10130716 SH0761 M10130716 SH1276 M10130717 SG2026 M10130717 SH0935 M10130717 SH1279 M10130718 SH0729 M10130722 USG294 M10130722 SH0761 M10130725 USG022 M10130725 SH1279 M10130726 SH1557 M10130726 USG294 M10130726 SH1391 M10130731 USG294 M10130731 SH0495 M10130801 SH1182 M10130802 SH0495 M10130805 SH0059 M10130805 SH0729 M10130806 USG294 M10130806 SH1391 M10130812 SH1276 M10130814 SH0035 M10130815 SH1378 M10130815 SH0729 M10130815 SH2144 M10130816 SH1570 M10130816 USG721 M10131105 USG294 M10131111 SH0935 M10131111 SH0729 M10131115 USG294 M10131115 SH1279 M10131119 USG022 M10131120 USG294 M10131120 SH1378 M10131120 SH1279 M10131121 SG704 M10131121 USG022 M10131122 SH0935 M10131122 SH0761 M10131123 SH0547 M10131123 SH1837 M10131123 SH1390 M10131128 SH0825 M10131128 SH1378 M10131202 SH0761 M10131202 SH1276 M10131204 SH1604 M10131206 SH1182 M10131206 SH0547 M10131206 SH2144 M10131207 SH0729 M10131207 SH1279 M10131207 SH1276 M10131211 USG294 M10131212 SH0059 M10131212 USG022 M10131212 SH0729 M10131212 SH1279 M10131214 SG704 M10131216 SH0729 M10131217 SH1570 M10131217 SH1557 M10131217 SH0729 M10131217 SH1279 M10131217 SH2144 M10131218 SH1368 M10140108 SH0761 M10140113 SH1378 M10140115 SH1390 M10140115 SH0935 M10140116 SH1557 M10140116 USG721 M10140116 SH1622 M10140117 USG721 M10140120 USG294 M10140120 USG022 M10140123 USG294 M10140123 SH1015 M10140212 SH0547 M10140212 SH1368 M10140212 USG294 M10140212 SH0761 M10140213 SG704 M10140213 SH0729 M10140213 SH0495 M10140213 SH1279 M10140217 SH1276 M10140306 SH1570 M10140328 SH1378 M10140328 SH1391 M10140401 SH1557 M10140401 SH0729 M10140402 SH1385 M10140402 SH1279 M10140416 SH1997 M10140416 SH1391 M11130527 SH1279 M11130603 SH0059 M11130603 SH0729 M11130606 USG721 M11130606 SH1385 M11130607 SH1837 M11130607 SH1279 M11130611 SH0059 M11130613 USG721 M11130613 SH1391 M11130614 SH1570 M11130614 SH1837 M11130618 SH0059 M11130618 SH1390 M11130622 SH1390 M11130622 SH1279 M11130622 SH1276 M11130703 SH1390 M11130708 USG022 M11130709 USG294 M11130710 SH1837 M11130710 SH0935 M11130710 SH1279 M11130711 SH0495 M11130712 USG294 M11130713 SH1368 M11130713 SH0729 M11130716 SH0059 M11130716 SH0729 M11130716 SH2144 M11130718 USG689 M11130718 USG294 M11130722 SH0825 M11130723 SH1378 M11130724 USG294 M11130726 SG704 M11130726 SH1557 M11130726 SH0761 M11130730 SH1390 M11130805 SH1368 M11130805 SG2026 M11130809 USG689 M11130813 SG704 M11130813 USG294 M11130814 SH1837 M11130814 USG022 M11130815 SH0729 M11130815 SH1015 M11130816 USG294 M11130816 SH0729 M11130816 SH1279 M11131111 SH0495 M11131111 USG518 M11131202 USG294 M11131202 SH1378 M11131204 SH0935 M11131205 SH1391 M11131205 SH1279 M11131207 USG721 M11131207 SH0935 M11131207 SH0729 M11131207 SH0495 M11131207 SH2144 M11140108 USG294 M11140108 SH0495 M11140116 SH1378 M11140116 SH1279 M11140211 SH1557 M11140211 SH1378 M11140228 USG721 M11140228 SH1279 M12130531 SH0761 M12130603 SH0729 M12130608 SH0761 M12130610 SG704 M12130611 SH0059 M12130613 USG022 M12130613 SH1391 M12130615 USG518 M12130620 SH0935 M12130620 SH1385 M12130621 SH2144 M12130624 USG294 M12130624 SH1015 M12130702 SH0729 M12130704 SH0495 M12130705 SH1279 M12130708 SH1385 M12130709 SH1276 M12130710 SH1076 M12130710 SH0495 M12130712 USG721 M12130712 SH1385 M12130715 SH0547 M12130715 USG022 M12130717 SH0729 M12130717 SH1391 M12130722 SH0035 M12130726 SG704 M12130726 SH1279 M12130729 SH0729 M12130801 SH1182 M12130802 USG294 M12130802 SH2144 M12130805 SH1557 M12130807 USG294 M12130807 USG022 M12130808 SH1279 M12130809 SH1378 M12130809 SH0761 M12131123 USG689 M13130601 USG294 M13130605 SH0935 M13130605 SH1276 M13130606 SH0035 M13130608 SH0059 M13130613 SH0935 M13130613 SH0035 M13130615 SH1279 M13130617 USG294 M13130620 USG721 M13130621 SH1368 M13130621 SH1378 M13130622 SH1015 M13130624 SH1368 M13130624 SH0761 M13130626 SH0729 M13130702 USG294 M13130703 SH1279 M13130703 SH2144 M13130708 SH1279 M13130712 SH2144 M13130712 SH1276 M13130715 USG721 M13130715 SH1378 M13130715 SH0729 M13130716 USG022 M13130716 SH1076 M13130722 SH1570 M13130722 USG518 M13130724 SH1279 M13130726 USG294 M13130726 SH0825 M13130726 SH0935 M13130731 USG294 M13130731 SH0729 M13130807 SH1378 M13130808 USG294 M13131123 SH1557 M13131123 SH0729 M14130606 SH1391 M14130606 USG518 M14130607 USG294 M14130610 USG294 M14130610 SH0729 M14130613 SH0035 M14130614 SH1622 M14130617 USG294 M14130617 SH0761 M14130620 USG294 M14130620 USG721 M14130621 SH0825 M14130626 SH1570 M14130626 SH1391 M14130702 SH1279 M14130703 USG294 M14130724 SH1015 M14130724 SH1276 M14130725 SH1622 M14130730 USG294 N10130926 SH0495 N10131217 SH1015 N10131217 SH2144 N10140106 SH1015 N10140109 SH1385 N10140110 SH1378 N10140120 SH0729 N10140120 SH1279 N10140120 SH0761 N10140123 SH1378 N10140130 SH0825 N10140130 SH1378 N10140130 SH0935 N10140204 SH1837 N10140204 USG721 N10140204 SH0729 N10140207 SH1276 N10140210 SH0059 N10140210 SH1557 N10140210 USG294 N10140210 SH0729 N10140210 SH2125 N10140211 SH0935 N10140214 SG704 N10140214 USG294 N10140214 SH0495 N10140217 USG294 N10140221 SH0495 N10140224 SH0729 N10140313 USG294 N10140313 SH1378 N10140313 SH0729 N10140313 SH0495 N10140314 SH1557 N10140325 SH0761 N10140401 SH1390 N10140401 SH2186 N10140403 SH1182 N10140403 USG294 N10140408 SH2144 N10140410 SH1378 N10140410 SH0495 N10140410 SH1015 N10140414 USG294 N10140422 USG294 N10140422 SH0761 N10140423 USG294 N10140424 SH1378 N10140425 SH1390 N10140425 USG022 N10140428 SH1015 N10140428 SH1279 N10140428 SH2144 N10140501 USG294 N10140501 SH1391 N10140501 SH2125 N10140501 USG518 N10140507 SH1557 N10140507 SH0729 N10140508 SH0729 N10140512 SH1378 N10140512 SH0935 N10140512 SH1279 N10140513 USG518 N10140514 USG721 N10140519 SH1182 N10140519 USG022 N10140519 SH0495 N10140520 USG721 N10140520 SH0729 N10140523 SH1557 N10140523 SH2144 N10140527 USG721 N10140527 SH1279 N10140530 USG721 N11140204 SH0059 N11140204 USG294 N11140204 SH0729 N11140204 SH0035 N11140314 SH0547 N11140314 USG294 N11140314 USG022 N11140321 USG022 N11140423 SH1378 N11140423 SH2125 N11140428 SH0935 N11140428 SH0761 N11140501 SG704 N11140501 SH0035 N11140501 SH2125 N11140508 SH0059 N11140508 SH0761 N11140509 SH0729 N11140509 SH2144 N11140513 SH0547 N11140514 SH1378 N11140515 SH1279 N11140515 SH0761 N11140516 SH1622 N11140519 SH0547 N11140519 SH1837 N11140521 USG294 N11140526 USG689 N11140526 SH0825 N11140527 SH0729 N11140527 SH1279 N11140529 SH1378 N11140530 SH1076 N12140321 SH1182 N12140325 SH2144 N12140515 SH1378 N13140325 SH0729 N13140424 USG689 S10130603 SH1279 S11130530 SH0761 S11130603 USG294 S11130603 SH1378  Material Number: 420179-14 Batch / System Numbers: N10140620 SH1182 N11140730 SH1182 N13140808 SH1182 N11140904 SH1182 N11150109 SH1182 N11150228 SH1182 N12140620 SH1570 N11140923 SH1570 N11141111 SH1570 N11150228 SH1570 N11140630 SG704 N10140704 SG704 N10140721 SG704 N10140729 SG704 N10140811 SG704 N13140808 SG704 N11140814 SG704 N10140829 SG704 N10140917 SG704 N10140926 SG704 N10141217 SG704 N12141217 SG704 N13150302 SG704 N11140703 SH0547 N10140909 SH0547 N13140909 SH0547 N11141213 SH0547 N10150212 SH0547 N10140617 SH0059 N12140704 SH0059 N10140718 SH0059 N11140820 SH0059 N11140916 SH0059 N10141119 SH0059 N10141125 SH0059 N11150218 SH0059 N11140729 SH1997 N12140620 SH1557 N10140701 SH1557 N10140711 SH1557 N11140724 SH1557 N10140812 SH1557 N11140822 SH1557 N10140828 SH1557 N10140909 SH1557 N10141022 SH1557 N10141111 SH1557 N13141124 SH1557 N11141209 SH1557 N11141213 SH1557 N14141223 SH1557 N10150106 SH1557 N10150115 SH1557 N10150128 SH1557 N11150213 SH1557 N11150219 SH1557 N10150303 SH1557 N10150109 SH1964 N11150218 SH1964 N11140623 SH1837 N10141010 SH1837 N12140612 SH1390 N10140701 SH1390 N10140910 SH1390 N10141206 SH1390 N10150210 SH1390 N13150302 SH1390 N12140612 USG689 N11140701 USG689 N11141001 USG689 N11140806 SH1368 N10141116 SH1368 N12141213 SH1368 N11140610 USG294 N10140620 USG294 N10140701 USG294 N11140701 USG294 N10140711 USG294 N10140718 USG294 N11140730 USG294 N11140731 USG294 N11140820 USG294 N10140829 USG294 N13141023 USG294 N14141023 USG294 N11141104 USG294 N10141201 USG294 N11141210 USG294 N12141213 USG294 N12141217 USG294 N12150121 USG294 N11150123 USG294 N12150212 USG294 N10150219 USG294 N11150228 USG294 N13141125 USG294 N12140710 USG721 N10140806 USG721 N10140814 USG721 N11140829 USG721 N11140901 USG721 N10140903 USG721 N10141029 USG721 N11141103 USG721 N10141211 USG721 N14141223 USG721 N11150211 USG721 N10140701 USG022 N10140703 USG022 N10140806 USG022 N10140814 USG022 N11140917 USG022 N11141211 USG022 N10141213 USG022 N10141218 USG022 N11150115 USG022 N11150209 USG022 N11150211 USG022 N11141110 SH2186 N11141206 SH2186 N12141208 SH2186 N10141218 SH2186 N10140619 SH0825 N11140806 SH0825 N11140903 SH0825 N10141022 SH0825 N14141218 SH0825 N10140620 SH1378 N13140623 SH1378 N10140630 SH1378 N12140704 SH1378 N11140724 SH1378 N10140729 SH1378 N10140909 SH1378 N10140905 SH1378 N11141022 SH1378 N13141023 SH1378 N11141104 SH1378 N10141127 SH1378 N12141129 SH1378 N10141202 SH1378 N11141208 SH1378 N13141218 SH1378 N10141222 SH1378 N11150116 SH1378 N11150219 SH1378 N11150225 SH1378 N10140701 SH0935 N12140710 SH0935 N10140813 SH0935 N13140808 SH0935 N11140909 SH0935 N10141028 SH0935 N10141104 SH0935 N11141208 SH0935 N12141210 SH0935 N11150126 SH0935 N11150204 SH0935 N12150212 SH0935 N12140623 SH0729 N12140704 SH0729 N10140721 SH0729 N10140730 SH0729 N11140729 SH0729 N10140815 SH0729 N10140820 SH0729 N10140904 SH0729 N11140904 SH0729 N10140909 SH0729 N12140910 SH0729 N13141022 SH0729 N11141105 SH0729 N10141127 SH0729 N12141202 SH0729 N11150119 SH0729 N10150109 SH0729 N11150123 SH0729 N11150211 SH0729 N10150224 SH0729 N13150225 SH0729 N10140630 SH0035 N11140801 SH0035 N10141001 SH0035 N11141201 SH0035 N10150218 SH0035 N10140617 SH1391 N13140808 SH1391 N11141129 SH1391 N12150216 SH1391 N13150224 SH1391 N10140607 SH2125 N12141125 SH2125 N10140711 SH1622 N12150121 SH1622 N12140910 SH1076 N11140611 SH1604 N12141023 SH1604 N12141211 SH1604 N10140617 SH0495 N10140703 SH0495 N11140707 SH0495 N10140722 SH0495 N11140812 SH0495 N11140904 SH0495 N10140910 SH0495 N10141103 SH0495 N10141124 SH0495 N11141208 SH0495 N11141217 SH0495 N10141222 SH0495 N11150203 SH0495 N10150225 SH0495 N13150302 SH0495 N10140607 SH1015 N11140612 SH1015 N10140711 SH1015 N11140724 SH1015 N11140926 SH1015 N10141001 SH1015 N10141022 SH1015 N10141106 SH1015 N12141116 SH1015 N10150209 SH1015 N12150216 SH1015 N10150216 SH1015 N13150302 SH1015 N10140619 SH1385 N10140729 SH1385 N12140808 SH1385 N11140917 SH1385 N10141202 SH1385 N10150219 SH1385 N13150302 SH1385 N11140612 SH1279 N10140613 SH1279 N10140620 SH1279 N11140630 SH1279 N11140711 SH1279 N10140718 SH1279 N10140820 SH1279 N13140909 SH1279 N11140926 SH1279 N10141010 SH1279 N10141104 SH1279 N10141110 SH1279 N13141116 SH1279 N12141208 SH1279 N12141211 SH1279 N12141217 SH1279 N10150109 SH1279 N11150218 SH1279 N10150228 SH1279 N11150303 SH1279 N11140610 SH2144 N11140611 SH2144 N10140904 SH2144 N10140903 SH2144 N11140909 SH2144 N10141021 SH2144 N12141116 SH2144 N12141124 SH2144 N11141201 SH2144 N12141222 SH2144 N10150203 SH2144 N10150226 SH2144 N12140630 SH0761 N10140722 SH0761 N11140801 SH0761 N11140923 SH0761 N11141103 SH0761 N11141201 SH0761 N12141213 SH0761 N11141217 SH0761 N12150121 SH0761 N11150211 SH0761 N11140630 SH1276 N11140711 SH1276 N10140806 SH1276 N11140822 SH1276 N10141110 USG518 N10141116 USG518 N12141125 USG518 N10150217 USG518  Material Number: 420179-15 Batch / System Numbers: N11150625 SH1182 N10150810 SH1182 N11150810 SH1182 N10150911 SH1182 N10150916 SH1182 N11150922 SH1182 N10151117 SH1182 N12151202 SH1182 N10160107 SH1182 N10160129 SH1182 N11160309 SH1182 N10160620 SH1182 N12160708 SH1182 N10160715 SH1182 N10161014 SH1182 N11161116 SH1182 N11170106 SH1182 N12170110 SH1182 N10170126 SH1182 N11170217 SH1182 N10170309 SH1182 N11170526 SH1182 N10170626 SH1182 N11170706 SH1182 N11170627 SH1182 N10170830 SH1182 N10171128 SH1182 N10180125 SH1182 N10180222 SH1182 N10180326 SH1182 N10180316 SH1182 N10180424 SH1182 N10150605 SH1570 N10150603 SH1570 N11150825 SH1570 N10151015 SH1570 N10151202 SH1570 N11151216 SH1570 N10160112 SH1570 N10160422 SH1570 N14160725 SH1570 N12160712 SH1570 N10161221 SH1570 N12170309 SH1570 N11170427 SH1570 N10170630 SH1570 N11170609 SH1570 N10180208 SH1570 N10180405 SH1570 N11180220 SH1570 N11150311 SG704 N10150416 SG704 N11150505 SG704 N11150609 SG704 N11150730 SG704 N10150729 SG704 N10150801 SG704 N10151005 SG704 N10151202 SG704 N12151208 SG704 N10151222 SG704 N10160119 SG704 N10160220 SG704 N13160305 SG704 N11160504 SG704 N11160609 SG704 N13160801 SG704 N11160912 SG704 N10161013 SG704 N11161102 SG704 N11170103 SG704 N11170217 SG704 N10170223 SG704 N10170421 SG704 N11170427 SG704 N10170515 SG704 N11170526 SG704 N10170626 SG704 N10170714 SG704 N10170728 SG704 N10171002 SG704 N10171115 SG704 N10171204 SG704 N10171207 SG704 N10180104 SG704 N10180125 SG704 N10180202 SG704 N11180123 SG704 N10180321 SG704 N10180306 SG704 N10180618 SG704 N13150304 SH0547 N12150511 SH0547 N11150519 SH0547 N10150624 SH0547 N10150921 SH0547 N10150923 SH0547 N11151210 SH0547 N13151208 SH0547 N10160210 SH0547 N10160414 SH0547 N10160519 SH0547 N11160614 SH0547 N11160811 SH0547 N11150312 SH0059 N11150401 SH0059 N12150319 SH0059 N10150507 SH0059 N10150519 SH0059 N10150601 SH0059 N10150602 SH0059 N10150623 SH0059 N10150731 SH0059 N10150903 SH0059 N10150929 SH0059 N11151030 SH0059 N10151209 SH0059 N12151202 SH0059 N10151221 SH0059 N11151210 SH0059 N10160718 SH0059 N12160815 SH0059 N13160823 SH0059 N10161020 SH0059 N10161104 SH0059 N10161116 SH0059 N11161117 SH0059 N10170425 SH0059 N10170426 SH0059 N10170509 SH0059 N10170610 SH0059 N10170704 SH0059 N10170717 SH0059 N10170718 SH0059 N10170720 SH0059 N10170926 SH0059 N10171109 SH0059 N10171205 SH0059 N10171215 SH0059 N10171214 SH0059 N10180202 SH0059 N10180509 SH0059 N11180511 SH0059 N11150312 SH1557 N10150330 SH1557 N10150417 SH1557 N11150429 SH1557 N10150526 SH1557 N11150528 SH1557 N10150622 SH1557 N10150803 SH1557 N10150909 SH1557 N11150825 SH1557 N10151009 SH1557 N11151012 SH1557 N12151118 SH1557 N11160116 SH1557 N10160215 SH1557 N10160225 SH1557 N10160408 SH1557 N11160504 SH1557 N10160516 SH1557 N11160606 SH1557 N10160623 SH1557 N11160614 SH1557 N11160715 SH1557 N11160808 SH1557 N13160823 SH1557 N11160930 SH1557 N12160930 SH1557 N10161128 SH1557 N11161202 SH1557 N10161219 SH1557 N10170201 SH1557 N11170120 SH1557 N10170225 SH1557 N12170404 SH1557 N11170421 SH1557 N10170509 SH1557 N11170526 SH1557 N10170606 SH1557 N10170706 SH1557 N10170718 SH1557 N10170810 SH1557 N10170815 SH1557 N10171011 SH1557 N10171023 SH1557 N10171117 SH1557 N10180123 SH1557 N10180202 SH1557 N10180216 SH1557 N10180302 SH1557 N11180413 SH1557 N10180423 SH1557 N10180306 SH1557 N10180418 SH1557 N10150427 SH1964 N11150429 SH1964 N10150622 SH1964 N11150626 SH1964 N11150728 SH1964 N10150814 SH1964 N10151014 SH1964 N11150928 SH1964 N10151102 SH1964 N10160106 SH1964 N10160303 SH1964 N10160321 SH1964 N10160505 SH1964 N10160705 SH1964 N11160809 SH1964 N10161028 SH1964 N11161107 SH1964 N11161125 SH1964 N10170309 SH1964 N10170404 SH1964 N10170519 SH1964 N10170526 SH1964 N11170620 SH1964 N10170707 SH1964 N11170906 SH1964 N10171101 SH1964 N10180119 SH1964 N10180201 SH1964 N10180209 SH1964 N10180122 SH1964 N10180322 SH1964 N10180706 SH1964 N11150622 SH1837 N12150725 SH1837 N10150804 SH1837 N10150714 SH1837 N10160105 SH1837 N12160831 SH1837 N12161014 SH1837 N10161128 SH1837 N10170913 SH1837 N10171020 SH1837 N10180219 SH1837 N11180511 SH1837 N10180301 SH1822 N13150318 SH1390 N10150518 SH1390 N10150624 SH1390 N10150623 SH1390 N10151009 SH1390 N10151028 SH1390 N12151202 SH1390 N11160225 SH1390 N12160305 SH1390 N11160419 SH1390 N11160428 SH1390 N10160628 SH1390 N11160725 SH1390 N11160714 SH1390 N13160830 SH1390 N13160815 SH1390 N11161010 SH1390 N11161028 SH1390 N10161124 SH1390 N11161223 SH1390 N11170421 SH1390 N10170505 SH1390 N10170612 SH1390 N10170707 SH1390 N10171027 SH1390 N10171101 SH1390 N10180112 SH1390 N10180215 SH1390 N10180302 SH1390 N10180306 SH1390 N10150325 USG689 N10150630 USG689 N12150525 USG689 N10150729 USG689 N10150814 USG689 N10150904 USG689 N10160415 USG689 N10160512 USG689 N11160901 USG689 N10161003 USG689 N10170202 USG689 N10170209 USG689 N12170304 USG689 N11171221 USG689 N10171214 USG689 N10180326 USG689 N10180503 USG689 N10150422 SH1368 N11150708 SH1368 N10150730 SH1368 N11150922 SH1368 N10160106 SH1368 N11160213 SH1368 N10160317 SH1368 N11160418 SH1368 N10170116 SH1368 N11170517 SH1368 N11171220 SH1368 N10171214 SH1368 N10180413 SH1368 N10180504 SH1368 N11150306 USG294 N10150324 USG294 N10150326 USG294 N11150407 USG294 N13150318 USG294 N11150416 USG294 N10150424 USG294 N11150505 USG294 N11150519 USG294 N10150528 USG294 N11150529 USG294 N10150616 USG294 N12150609 USG294 N10150708 USG294 N10150727 USG294 N10150804 USG294 N10150810 USG294 N10150824 USG294 N10150902 USG294 N10150909 USG294 N10150916 USG294 N11150824 USG294 N10151005 USG294 N11151013 USG294 N12150820 USG294 N11151014 USG294 N11151030 USG294 N10151203 USG294 N12151006 USG294 N11151208 USG294 N10151216 USG294 N10160104 USG294 N12160116 USG294 N11160128 USG294 N10160210 USG294 N10160213 USG294 N10160301 USG294 N10160307 USG294 N11160312 USG294 N10160321 USG294 N11160330 USG294 N10160422 USG294 N10160505 USG294 N10160512 USG294 N10160517 USG294 N10160613 USG294 N10160623 USG294 N10160630 USG294 N10160714 USG294 N13160803 USG294 N11160809 USG294 N11160815 USG294 N11160818 USG294 N11160906 USG294 N14160815 USG294 N10160930 USG294 N14160913 USG294 N10161010 USG294 N10161021 USG294 N10161014 USG294 N11161124 USG294 N10160915 USG294 N11170103 USG294 N10170117 USG294 N11170126 USG294 N11170120 USG294 N11170309 USG294 N11170327 USG294 N10170330 USG294 N11170427 USG294 N10170428 USG294 N10170427 USG294 N10170511 USG294 N10170607 USG294 N11170606 USG294 N10170610 USG294 N10170620 USG294 N12170610 USG294 N10170707 USG294 N10170720 USG294 N10170803 USG294 N10170810 USG294 N10170901 USG294 N10170907 USG294 N10170929 USG294 N10171030 USG294 N10171128 USG294 N10171207 USG294 N10171219 USG294 N10180119 USG294 N10180130 USG294 N11180123 USG294 N10180209 USG294 N10180314 USG294 N10180326 USG294 N10180413 USG294 N10180424 USG294 N10180316 USG294 N11180423 USG294 N10180306 USG294 N10180510 USG294 N10150304 USG721 N11150312 USG721 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USG022 N11160310 USG022 N10160316 USG022 N10160419 USG022 N10160531 USG022 N11160615 USG022 N11160725 USG022 N10160830 USG022 N11160927 USG022 N10161028 USG022 N11161107 USG022 N10161122 USG022 N11170120 USG022 N11170403 USG022 N10170504 USG022 N10170515 USG022 N11160811 USG022 N10170626 USG022 N11170706 USG022 N10170720 USG022 N11170814 USG022 N10171017 USG022 N10171101 USG022 N11171221 USG022 N10171214 USG022 N10180504 USG022 N10180322 USG022 N10150605 SH2186 N10150624 SH2186 N10151106 SH2186 N12151202 SH2186 N11160513 SH2186 N10160705 SH2186 N12170225 SH2186 N10170404 SH2186 N10170530 SH2186 N10171023 SH2186 N10171128 SH2186 N10180426 SH2186 N12150511 SH0825 N11150820 SH0825 N11151205 SH0825 N11160120 SH0825 N10160303 SH0825 N14160725 SH0825 N10160809 SH0825 N14160815 SH0825 N11160923 SH0825 N10161031 SH0825 N10170311 SH0825 N10170526 SH0825 N10170630 SH0825 N10171215 SH0825 N10180129 SH0825 N10180328 SH0825 N10150312 SH1378 N10150318 SH1378 N10150506 SH1378 N11150525 SH1378 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SH1378 N11180511 SH1378 N10180702 SH1378 N10150306 SH0935 N10150408 SH0935 N12150511 SH0935 N11150605 SH0935 N10150622 SH0935 N12150609 SH0935 N10150923 SH0935 N11150922 SH0935 N10151014 SH0935 N10151026 SH0935 N12151006 SH0935 N10151214 SH0935 N10151216 SH0935 N10151222 SH0935 N11160310 SH0935 N12160309 SH0935 N11160606 SH0935 N10160617 SH0935 N11160714 SH0935 N10160718 SH0935 N10161003 SH0935 N11161004 SH0935 N10161020 SH0935 N11161026 SH0935 N11161124 SH0935 N10170110 SH0935 N12170208 SH0935 N10170301 SH0935 N11170410 SH0935 N10170510 SH0935 N10170606 SH0935 N10170615 SH0935 N10170623 SH0935 N10170707 SH0935 N10170901 SH0935 N11170906 SH0935 N10171026 SH0935 N10171113 SH0935 N10171208 SH0935 N10180111 SH0935 N10180130 SH0935 N10180216 SH0935 N10180326 SH0935 N10180405 SH0935 N11180413 SH0935 N10180306 SH0935 N10150326 SH0729 N11150326 SH0729 N12150311 SH0729 N10150424 SH0729 N10150514 SH0729 N10150611 SH0729 N10150619 SH0729 N10150622 SH0729 N12150722 SH0729 N10150730 SH0729 N10150731 SH0729 N10150824 SH0729 N11150911 SH0729 N11150824 SH0729 N10150929 SH0729 N10151009 SH0729 N11150924 SH0729 N10151014 SH0729 N10150725 SH0729 N11151020 SH0729 N10151026 SH0729 N10151209 SH0729 N11151205 SH0729 N10160107 SH0729 N10160128 SH0729 N13160128 SH0729 N10160215 SH0729 N10160301 SH0729 N11160310 SH0729 N11160317 SH0729 N10160322 SH0729 N10160426 SH0729 N11160506 SH0729 N10160607 SH0729 N10160615 SH0729 N10160620 SH0729 N11160624 SH0729 N12160815 SH0729 N11160811 SH0729 N13160823 SH0729 N10161005 SH0729 N12161014 SH0729 N10161122 SH0729 N10170111 SH0729 N11170324 SH0729 N12170329 SH0729 N11170417 SH0729 N10170505 SH0729 N11170512 SH0729 N10170707 SH0729 N10170712 SH0729 N10170803 SH0729 N10170926 SH0729 N10171023 SH0729 N10171207 SH0729 N10171206 SH0729 N10171228 SH0729 N10180102 SH0729 N10180111 SH0729 N10180122 SH0729 N10180618 SH0729 N10150330 SH0035 N13150427 SH0035 N11150722 SH0035 N11150904 SH0035 N12151204 SH0035 N12151208 SH0035 N10160412 SH0035 N11160513 SH0035 N10160803 SH0035 N10161010 SH0035 N10161013 SH0035 N10170203 SH0035 N11170405 SH0035 N10170610 SH0035 N10170803 SH0035 N10171109 SH0035 N10180111 SH0035 N10180301 SH0035 N10150901 SH1391 N13150304 SH2125 N11150818 SH2125 N10160706 SH2125 N11160815 SH2125 N11161012 SH2125 N11161208 SH2125 N10170620 SH2125 N10170901 SH2125 N10171109 SH2125 N10180103 SH2125 N10180221 SH2125 N10180122 SH2125 N10180418 SH2125 N10150417 SH1622 N10150804 SH1622 N11160105 SH1622 N10160226 SH1622 N11160923 SH1622 N10170316 SH1622 N10171002 SH1622 N10171027 SH1622 N10180129 SH1622 N10160322 SH1076 N10160803 SH1076 N11161013 SH1076 N10170106 SH1076 N11170607 SH1076 N10171025 SH1076 N10171109 SH1076 N10171204 SH1076 N10180207 SH1076 N11180220 SH1076 N12151204 SH1604 N11160614 SH1604 N10161004 SH1604 N10170202 SH1604 N10170322 SH1604 N10170408 SH1604 N12170606 SH1604 N10171030 SH1604 N10171219 SH1604 N10180221 SH1604 N10180305 SH1604 N10180424 SH1604 N10180511 SH1604 N10180418 SH1604 N11150401 SH0495 N10150413 SH0495 N10150506 SH0495 N11150506 SH0495 N10150611 SH0495 N11150609 SH0495 N10150623 SH0495 N11150706 SH0495 N10150804 SH0495 N10150813 SH0495 N10150929 SH0495 N10151118 SH0495 N11151208 SH0495 N11160823 SH0495 N10161114 SH0495 N10170209 SH0495 N11170317 SH0495 N11170526 SH0495 N11170606 SH0495 N11170706 SH0495 N10170714 SH0495 N10180413 SH0495 N10150304 SH1015 N12150311 SH1015 N11150416 SH1015 N10150506 SH1015 N11150509 SH1015 N10150528 SH1015 N11150814 SH1015 N10150921 SH1015 N10151012 SH1015 N10151109 SH1015 N10151110 SH1015 N11151103 SH1015 N10151106 SH1015 N10160106 SH1015 N10160118 SH1015 N12160128 SH1015 N10160224 SH1015 N10160307 SH1015 N12160305 SH1015 N10160420 SH1015 N10160504 SH1015 N10160630 SH1015 N11160708 SH1015 N12160712 SH1015 N10160801 SH1015 N10160802 SH1015 N10160816 SH1015 N11160815 SH1015 N11160831 SH1015 N10161017 SH1015 N10161110 SH1015 N10161104 SH1015 N10161107 SH1015 N10161116 SH1015 N10161219 SH1015 N11170126 SH1015 N11170309 SH1015 N10170322 SH1015 N11170425 SH1015 N11170427 SH1015 N11170517 SH1015 N11170526 SH1015 N10170607 SH1015 N10170724 SH1015 N10170816 SH1015 N10170824 SH1015 N10171102 SH1015 N10171128 SH1015 N10180424 SH1015 N10180227 SH1015 N10180316 SH1015 N10180328 SH1015 N10150521 SH1385 N11150609 SH1385 N11151013 SH1385 N11151207 SH1385 N11151210 SH1385 N11160419 SH1385 N10160706 SH1385 N11160906 SH1385 N14160913 SH1385 N11161007 SH1385 N11161124 SH1385 N11170111 SH1385 N11170606 SH1385 N10170704 SH1385 N10170710 SH1385 N11170609 SH1385 N10171206 SH1385 N11171220 SH1385 N10180206 SH1385 N10180413 SH1385 N10180405 SH1385 N10180412 SH1385 N11180216 SH1385 N10150311 SH1279 N10150313 SH1279 N11150429 SH1279 N11150507 SH1279 N10150519 SH1279 N10150528 SH1279 N11150529 SH1279 N11150626 SH1279 N11150722 SH1279 N10150722 SH1279 N10150805 SH1279 N10150901 SH1279 N10150902 SH1279 N11150820 SH1279 N10150915 SH1279 N10151015 SH1279 N10151016 SH1279 N10151117 SH1279 N12151118 SH1279 N10160106 SH1279 N12160116 SH1279 N12160130 SH1279 N13160219 SH1279 N10160308 SH1279 N10160412 SH1279 N10160420 SH1279 N11160418 SH1279 N10160516 SH1279 N10160523 SH1279 N10160627 SH1279 N11160712 SH1279 N11160802 SH1279 N10160901 SH1279 N12160831 SH1279 N11161003 SH1279 N11161007 SH1279 N11160719 SH1279 N11161130 SH1279 N10170103 SH1279 N10170201 SH1279 N10170324 SH1279 N11170330 SH1279 N10170425 SH1279 N10170526 SH1279 N10170608 SH1279 N11170607 SH1279 N11170620 SH1279 N10170717 SH1279 N10170724 SH1279 N10170815 SH1279 N10170929 SH1279 N10171030 SH1279 N10171102 SH1279 N10180103 SH1279 N10180119 SH1279 N10180131 SH1279 N10180202 SH1279 N10180215 SH1279 N10180326 SH1279 N11180413 SH1279 N10180328 SH1279 N10180220 SH1279 N11150306 SH2144 N10150407 SH2144 N10150413 SH2144 N10150521 SH2144 N10150602 SH2144 N11150708 SH2144 N11150722 SH2144 N10150911 SH2144 N11150724 SH2144 N11151012 SH2144 N10151202 SH2144 N10151216 SH2144 N13160128 SH2144 N10160206 SH2144 N10160222 SH2144 N10160303 SH2144 N10160322 SH2144 N10160504 SH2144 N11160509 SH2144 N10160714 SH2144 N10160718 SH2144 N13160912 SH2144 N11160928 SH2144 N12160930 SH2144 N10161107 SH2144 N11161125 SH2144 N10170103 SH2144 N10170202 SH2144 N11170223 SH2144 N11170403 SH2144 N10170421 SH2144 N10170505 SH2144 N10170515 SH2144 N10170626 SH2144 N10170824 SH2144 N10170926 SH2144 N10171115 SH2144 N10171221 SH2144 N10180119 SH2144 N10180221 SH2144 N11180125 SH2144 N11180216 SH2144 N10180220 SH2144 N10180706 SH2144 N13150304 SH0761 N10150413 SH0761 N11150509 SH0761 N11150521 SH0761 N10150617 SH0761 N10150619 SH0761 N11150622 SH0761 N11150601 SH0761 N12150730 SH0761 N11150814 SH0761 N10150917 SH0761 N10151012 SH0761 N10151013 SH0761 N11151012 SH0761 N10151104 SH0761 N11151027 SH0761 N12151117 SH0761 N10151221 SH0761 N10160225 SH0761 N10160307 SH0761 N11160321 SH0761 N11160330 SH0761 N11160418 SH0761 N10160609 SH0761 N11160620 SH0761 N10160705 SH0761 N11160823 SH0761 N12160831 SH0761 N13160912 SH0761 N11160922 SH0761 N10161027 SH0761 N10161110 SH0761 N11161110 SH0761 N11160719 SH0761 N10170202 SH0761 N11170126 SH0761 N10170213 SH0761 N10170210 SH0761 N11170304 SH0761 N11170309 SH0761 N10170324 SH0761 N10170405 SH0761 N10170424 SH0761 N10170504 SH0761 N10170606 SH0761 N10170706 SH0761 N10170704 SH0761 N10170712 SH0761 N10170913 SH0761 N10170929 SH0761 N10171025 SH0761 N10171113 SH0761 N10171205 SH0761 N11171221 SH0761 N10180112 SH0761 N10180130 SH0761 N10180206 SH0761 N10180226 SH0761 N10180223 SH0761 N10180412 SH0761 N10180511 SH0761 N10180418 SH0761 N10180509 SH0761 N10180702 SH0761 N10150304 SH1276 N11150312 SH1276 N10151215 SH1276 N10150318 USG518 N13150427 USG518 N11160105 USG518 N11160312 USG518 N10170105 USG518 N11170103 RSH0152 N11170424 RSH0152 N11170706 RSH0152 N10171214 RSH0152 N10180122 RSH0152  Material Numbers: 420179-18 Batch / System Numbers: N12180517 SH1182 N11180518 SH1182 N11180518 SH1570 N10180516 SH0059 N10180521 SH0059 N10180409 SH0059 N10180411 SH1557 N11180605 SH1557 N10180613 SH1557 N10180615 SH1557 N10180409 SH1557 N10171213 SH1557 N10180604 SH1964 N10180615 SH1964 N10180409 SH1964 N10180416 SH1964 N11180518 SH1822 N11180605 SH1390 N12180517 USG689 N10180507 USG689 N11180524 USG294 N11180228 USG721 N11180517 USG721 N12180517 USG721 N10180507 USG721 N11180323 USG022 N11180517 USG022 N10180409 USG022 N10180529 SH2186 N11180110 SH0825 N11180525 SH0825 N11180228 SH1378 N10180430 SH1378 N11180517 SH1378 N11180524 SH1378 N10180416 SH0935 N10180523 SH0729 N10180521 SH0729 N10180525 SH0729 N10180521 SH2125 N10180619 SH2125 N11180518 SH1622 N10180516 SH1076 N10180615 SH1076 N10180605 SH0495 N10180430 SH1015 N10180409 SH1015 N10180416 SH1015 N10180507 SH1015 N11180613 SH1385 N10171123 SH1385 N12180517 SH1279 N10180521 SH1279 N10180613 SH1279 N11180524 SH1279 N11180601 SH2144 N11180613 SH2144 N11180517 SH0761 N10180619 SH0761  Material Number: 420179-22 Batch / System Numbers: N10180926 SH1182 N10181205 SH1182 N11181102 SH1182 N10190110 SH1182 N10190131 SH1182 N10190617 SH1182 N10190415 SH1182 N14190701 SH1182 N11190812 SH1182 N14190729 SH1182 N12200302 SH1182 N10200803 SH1182 N11200810 SH1182 N11181009 SG704 N11181019 SG704 N10181024 SG704 N10181129 SG704 N10181203 SG704 N11180927 SG704 N10190603 SH0059 N11200810 SH1997 N10180920 SH1557 N10181005 SH1557 N10181015 SH1557 N10181101 SH1557 N11181210 SH1557 N11181023 SH1557 N11181030 SH1557 N11181122 SH1557 N10190102 SH1557 N10190109 SH1557 N10190124 SH1557 N10190205 SH1557 N10190315 SH1557 N10190415 SH1557 N11190708 SH1557 N12190715 SH1557 N11190722 SH1557 N12190729 SH1557 N10190729 SH1557 N10190805 SH1557 N10190812 SH1557 N11191028 SH1557 N10191209 SH1557 N11200127 SH1557 N10200221 SH1557 N10200317 SH1557 N10200406 SH1557 N10180926 SH1557 N10200218 SH1557 N10200803 SH1557 N11200817 SH1557 N10200525 SH1557 N11180921 SH1964 N11180924 SH1964 N11181010 SH1964 N10181113 SH1964 N10181102 SH1964 N11181029 SH1964 N11190114 SH1964 N10190201 SH1964 N10190306 SH1964 N12190603 SH1964 N11190701 SH1964 N10190708 SH1964 N11190708 SH1964 N10190722 SH1964 N12190722 SH1964 N10190808 SH1964 N10190902 SH1964 N13190805 SH1964 N13200127 SH1964 N10200221 SH1964 N12200127 SH1964 N10200406 SH1964 N11200810 SH1964 N11200309 SH1964 N10190206 SH1837 N11190715 SH1837 N10200218 SH1837 N10200622 SH1837 N10200525 SH1837 N10180920 SH1822 N10190121 SH1822 N11190715 SH1822 N11191028 SH1822 N11200810 SH1822 N10180918 SH1390 N11180919 SH1390 N10181217 SH1390 N10181102 SH1390 N10180927 SH1390 N11181030 SH1390 N14190701 SH1390 N10190722 SH1390 N13190805 SH1390 N11200323 SH1390 N10200309 SH1390 N11200309 SH1390 N11200817 SH1390 N10181122 USG689 N10181023 USG689 N11181030 USG689 N10190201 USG689 N11190812 USG689 N10181204 SH1368 N11191104 SH1368 N12200302 SH1368 N10180921 USG294 N11181024 USG294 N10181211 USG294 N10190610 USG294 N11190722 USG294 N10200323 USG294 N10200803 USG294 N11180920 USG721 N11180926 USG721 N10181003 USG721 N10181024 USG721 N11181211 USG721 N10190109 USG721 N10190111 USG721 N11190114 USG721 N11190327 USG721 N12190603 USG721 N10190415 USG721 N11190701 USG721 N12190708 USG721 N14190729 USG721 N10191007 USG721 N11191104 USG721 N11200127 USG721 N10200317 USG721 N11200323 USG721 N11200309 USG721 N10180919 USG022 N10181212 USG022 N10181217 USG022 N11181102 USG022 N10190104 USG022 N10190109 USG022 N10190603 USG022 N10190701 USG022 N11190617 USG022 N10190805 USG022 N10200217 USG022 N10200317 USG022 N14200127 USG022 N11200309 USG022 N10180926 SH2186 N10181017 SH2186 N10180925 SH2186 N10190225 SH2186 N10190315 SH2186 N11190327 SH2186 N10190722 SH2186 N11190805 SH2186 N11200817 SH2186 N10190201 SH0825 N11190715 SH0825 N12181023 SH1378 N10180928 SH1378 N10181102 SH1378 N11181023 SH1378 N10181207 SH1378 N11181022 SH1378 N11181101 SH1378 N10190107 SH1378 N10190111 SH1378 N10190225 SH1378 N10190306 SH1378 N11190327 SH1378 N10190617 SH1378 N10190708 SH1378 N11190709 SH1378 N12190722 SH1378 N13190805 SH1378 N11191104 SH1378 N11180918 SH0935 N11180921 SH0935 N11180925 SH0935 N10181122 SH0935 N10181114 SH0935 N10190104 SH0935 N10190124 SH0935 N10190131 SH0935 N10190214 SH2180 N12190603 SH2180 N10200221 SH2180 N12200127 SH2180 N10181005 SH0729 N10181203 SH0729 N11181101 SH0729 N10190104 SH0729 N10190315 SH0729 N12190708 SH0729 N11190715 SH0729 N11181101 SH1391 N10181211 SH1391 N11180921 SH2125 N10181218 SH2125 N10190124 SH2125 N10190312 SH2125 N10190603 SH2125 N12190708 SH2125 N10181101 SH1622 N10190114 SH1622 N10180919 SH1076 N12181023 SH1076 N11181210 SH1076 N11181029 SH1076 N10190124 SH1076 N10190701 SH1076 N12190722 SH1076 N11200810 SH1076 N11200309 SH1076 N11181008 SH1604 N10181205 SH1604 N13190708 SH1604 N11191028 SH1604 N10191209 SH1604 N12200302 SH1604 N10200317 SH1604 N10200406 SH1604 N10200601 SH1604 N12181011 SH0495 N11181010 SH0495 N10181204 SH0495 N10181212 SH0495 N10190114 SH0495 N10190314 SH0495 N11190327 SH0495 N13190708 SH0495 N11190805 SH0495 N12191014 SH0495 N10200803 SH0495 N10181113 SH1015 N11181114 SH1015 N12181023 SH1015 N10181012 SH1015 N11181101 SH1015 N10190124 SH1015 N11190124 SH1015 N10190306 SH1015 N10190315 SH1015 N10190408 SH1015 N11190722 SH1015 N11190812 SH1015 N14200127 SH1015 N10200221 SH1015 N11200323 SH1015 N10200406 SH1015 N11180925 SH1385 N11181009 SH1385 N10181015 SH1385 N10181113 SH1385 N11181114 SH1385 N10181217 SH1385 N11181011 SH1385 N10181221 SH1385 N10181218 SH1385 N10190115 SH1385 N10190205 SH1385 N11190617 SH1385 N14190701 SH1385 N11190708 SH1385 N12190708 SH1385 N14190708 SH1385 N10190729 SH1385 N13190805 SH1385 N10191007 SH1385 N10191021 SH1385 N11191104 SH1385 N11180919 SH1279 N10180921 SH1279 N10181015 SH1279 N10181203 SH1279 N10181121 SH1279 N10181012 SH1279 N10181123 SH1279 N10190102 SH1279 N11181029 SH1279 N10190312 SH1279 N10190610 SH1279 N11190701 SH1279 N14190708 SH1279 N11190709 SH1279 N10190730 SH1279 N10191021 SH1279 N10200221 SH1279 N11200217 SH1279 N12200302 SH1279 N10200803 SH1279 N10200810 SH1279 N11180920 SH2144 N10180926 SH2144 N11181024 SH2144 N11180927 SH2144 N10181102 SH2144 N11181030 SH2144 N10190115 SH2144 N10190227 SH2144 N12190603 SH2144 N12190701 SH2144 N11190715 SH2144 N10200323 SH2144 N10180919 SH0761 N11181010 SH0761 N10181017 SH0761 N10181101 SH0761 N10181114 SH0761 N10181102 SH0761 N10180927 SH0761 N10181023 SH0761 N11181031 SH0761 N11181122 SH0761 N10190116 SH0761 N10190513 SH0761 N14190708 SH0761 N10190709 SH0761 N10190805 SH0761 N11191104 SH0761 N10191209 SH0761 N11200217 SH0761 N10200317 SH0761 N10200218 SH0761 N10200601 SH0761 N10200810 SH0761 N10200622 SH0761 N10181217 USG518 N11180920 RSH0152 N11191104 RSH0152  Material Number: 420179-23 Batch / System Numbers: N13190522 SH1182 N10191209 SH1182 N10200831 SH1182 N11201026 SH1182 N10201130 SH1182 N11201207 SH1182 N11210316 SH1182 N10210405 SH1182 N11191007 SH1997 N11191014 SH1997 N11191209 SH1997 N11201026 SH1997 N11201130 SH1997 N10210830 SH1997 N10210913 SH1997 K11220828 SH1997 K11231123 SH1997 K10240104 SH1997 K10240125 SH1997 N11191007 SH1557 N10191007 SH1557 N11191111 SH1557 N10200107 SH1557 N13200120 SH1557 N10200831 SH1557 N11201026 SH1557 N10201117 SH1557 N12210202 SH1557 N10210222 SH1557 N12210316 SH1557 N10210405 SH1557 N11210419 SH1557 N10210503 SH1557 N10210614 SH1557 N10210726 SH1557 N10210628 SH1557 N11210927 SH1557 N10211011 SH1557 K10220104 SH1557 N10191014 SH1964 N11200107 SH1964 N10200420 SH1964 N12200420 SH1964 N11200727 SH1964 N11200921 SH1964 N10201123 SH1964 N10201214 SH1964 N12201214 SH1964 N12210202 SH1964 N12210316 SH1964 N11210316 SH1964 N10210405 SH1964 N11210419 SH1964 N10210510 SH1964 N11210503 SH1964 N10210503 SH1964 N10210614 SH1964 N10210726 SH1964 N10210628 SH1964 N10210830 SH1964 N10210913 SH1964 N10211011 SH1964 N11210927 SH1964 K10220208 SH1964 K11220425 SH1964 K10220605 SH1964 K10220807 SH1964 K10220918 SH1964 N10191209 SH1837 N10201123 SH1837 K10220403 SH1837 K10240208 SH1837 N10200114 SH1822 N10201214 SH1822 N10210215 SH1822 N10210222 SH1822 N11190610 SH1390 N10190827 SH1390 N10200420 SH1390 N11200727 SH1390 N11201207 SH1390 N12210316 SH1390 N11210503 SH1390 N10210614 SH1390 N10210726 SH1390 N11210927 SH1390 N10210920 SH1390 K10220131 SH1390 N10211206 SH1390 N11210913 SH1390 K11220522 SH1390 K10220605 SH1390 K10220807 SH1390 K11220828 SH1390 K10230209 SH1390 N10190909 USG689 N10191014 USG689 N13200210 USG689 K10220605 USG689 K10220807 USG689 N11191028 SH1368 N10200824 SH1368 K10240104 SH1368 K10240125 SH1368 N11191007 USG294 N11200120 USG294 N11200210 USG294 N10200420 USG294 N11200921 USG294 N10201026 USG294 N10201123 USG294 N11201207 USG294 N10210112 USG294 N10210118 USG294 N10210222 USG294 N10210405 USG294 N10210412 USG294 N11210503 USG294 N10210802 USG294 N10210830 USG294 K10220131 USG294 K10220208 USG294 K10220403 USG294 K11220425 USG294 K11220522 USG294 K10220605 USG294 K10220918 USG294 K11220828 USG294 K10230209 USG294 K10240104 USG294 K10240125 USG294 N10190826 USG721 N10191007 USG721 N10190827 USG721 N10190917 USG721 N11200107 USG721 N10200120 USG721 N11200120 USG721 N10200703 USG721 N10200330 USG721 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SH1378 N12200831 SH1378 N13210222 SH1378 N11210316 SH1378 N10210405 SH1378 N11210412 SH1378 N10210503 SH1378 N10210830 SH1378 N10200420 SH0729 N11200727 SH0729 N11200921 SH0729 N11201214 SH0729 N11210215 SH0729 N13200120 SH0035 N10191209 SH1391 N10201019 SH1391 N11200921 SH1391 N10190827 SH2125 N13190522 SH2125 N10190909 SH1622 N11191014 SH1076 N10191209 SH1076 N10210112 SH1076 N10190909 SH1076 N10200914 SH1076 N11210412 SH1076 K10220918 SH1076 N10190909 SH1604 N10200703 SH1604 N10200907 SH1604 N11200120 SH0495 N10200810 SH0495 N11191104 SH1015 N11200107 SH1015 N13200120 SH1015 N10200120 SH1015 N13200210 SH1015 N11200713 SH1015 N10200831 SH1015 N11201026 SH1015 K10220124 SH1015 N10190909 SH1385 N14190522 SH1385 N10190827 SH1385 N11200107 SH1385 N10200204 SH1385 N10190827 SH1279 N10200114 SH1279 N11200120 SH1279 N11200210 SH1279 N12200420 SH1279 N10200831 SH1279 N10200420 SH1279 N10210111 SH1279 N11210111 SH1279 N10210614 SH1279 N10210726 SH1279 N10210802 SH1279 N10210913 SH1279 N10211011 SH1279 N10211206 SH1279 K10220104 SH1279 K10220208 SH1279 K10220403 SH1279 K11220425 SH1279 K11220522 SH1279 K10220605 SH1279 K10220807 SH1279 N10200107 SH2144 N11200107 SH2144 N10200713 SH2144 N10210111 SH2144 N10210118 SH2144 N10210412 SH2144 N10210628 SH2144 N10210802 SH2144 N10210830 SH2144 K11220425 SH2144 K10230209 SH2144 K11231123 SH2144 N11190819 SH0761 N11191028 SH0761 N11200107 SH0761 N12200120 SH0761 N10200114 SH0761 N11200210 SH0761 N11201214 SH0761 N12210202 SH0761 N10201130 SH0761 N12200831 SH0761 N10210405 SH0761 N10210503 SH0761 N10210614 SH0761 N10210726 SH0761 N10210830 SH0761 N10210628 SH0761 N10210913 SH0761 N11210913 SH0761 N10211206 SH0761 K10220208 SH0761 K11220425 SH0761 N10210222 SH0761 K11220522 SH0761 K10220605 SH0761 K10220807 SH0761 K11220828 SH0761 K10230209 SH0761 N10211011 SH0761 N12200420 RSH0152 N10210510 RSH0152 K10230209 RSH0152 K10220208 SH1513 K10220605 SH1513 K10220807 SH1513 K10220918 SH1513 K10230209 SH1513 K10240125 SH1513", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1696-2026%22", "url": "https://recallledger.net/recalls/device-z-1696-2026-brand-name-da-vinci-s-si-monopolar-curved-scissors-instrument-produ/"}, {"id": "fda-device-z-1561-2026", "source": "FDA", "category": "device", "recall_number": "Z-1561-2026", "title": "Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal... recall (Altruan GmbH)", "product": "Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.", "reason": "Product not cleared by the FDA.", "hazard_level": "Class II", "company": "Altruan GmbH", "company_location": "Massing, N/A, Germany", "date": "2025-12-19", "report_date": "2026-03-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "188 units", "codes": "Model No. AL-42153; No UDI; Lot Code: 6952804827274.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2026%22", "url": "https://recallledger.net/recalls/device-z-1561-2026-brand-name-bisaf-strep-a-self-test-test-for-detection-of-group-a-str/"}, {"id": "fda-device-z-1560-2026", "source": "FDA", "category": "device", "recall_number": "Z-1560-2026", "title": "Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci recall (Altruan GmbH)", "product": "Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.", "reason": "Product not cleared by the FDA.", "hazard_level": "Class II", "company": "Altruan GmbH", "company_location": "Massing, N/A, Germany", "date": "2025-12-19", "report_date": "2026-03-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "188 units", "codes": "Model No. SP-C310343-10; No UDI; Lot Code: 01242573.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1560-2026%22", "url": "https://recallledger.net/recalls/device-z-1560-2026-clearest-strep-a-cassette-test-test-to-determine-the-presence-of-grou/"}, {"id": "fda-device-z-1559-2026", "source": "FDA", "category": "device", "recall_number": "Z-1559-2026", "title": "Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic... recall (Altruan GmbH)", "product": "Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.", "reason": "Product not cleared by the FDA.", "hazard_level": "Class II", "company": "Altruan GmbH", "company_location": "Massing, N/A, Germany", "date": "2025-12-19", "report_date": "2026-03-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "188 units", "codes": "Model No. 41972; No UDI; Lot Code: 6933289812337.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1559-2026%22", "url": "https://recallledger.net/recalls/device-z-1559-2026-wondfo-streptococcal-a-at-home-self-test-at-home-test-for-group-a-bet/"}, {"id": "fda-drug-d-0397-2026", "source": "FDA", "category": "drug", "recall_number": "D-0397-2026", "title": "MR. 7 SUPER 700000 capsules recall (StuffbyNainax)", "product": "MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7", "reason": "Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil", "hazard_level": "Class I", "company": "StuffbyNainax", "company_location": "Huntsville, TX, United States", "date": "2025-12-15", "report_date": "2026-03-11", "status": "Ongoing", "distribution": "Product was distributed to 4 customers in the US.", "states": [], "nationwide": false, "quantity": "4", "codes": "All codes; Exp 12/31/2029", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0397-2026%22", "url": "https://recallledger.net/recalls/drug-d-0397-2026-mr-7-super-700000-capsules-1-capsule-blister-card-distributed-by-mr/"}, {"id": "fda-device-z-1492-2026", "source": "FDA", "category": "device", "recall_number": "Z-1492-2026", "title": "Gelsoft Plus recall (Vascutek, Ltd.)", "product": "Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E.      Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,", "reason": "Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.", "hazard_level": "Class II", "company": "Vascutek, Ltd.", "company_location": "Inchinnan, N/A, United Kingdom", "date": "2025-12-18", "report_date": "2026-03-11", "status": "Ongoing", "distribution": "US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA, NJ, OH, MI, DC, CO, VA, GA, IL, OR, ND, VT, MS, MA, IN, WA, AZ, MN, MD, IA, OK, MO, AL, WI, LA, AR, TN, CT, ME, NE, SC, KS, NV, KY, RI, WV, UT, MT, ID, AK, NH, DE, NM, SD, HI, WY.", "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": "37430", "codes": "All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P50E-B, 5037881167015; 632520PE, 632520PE-B, 5037881166773; 632412PE, 632412PE-B, 5037881166988; 631510PE, 631510PE-B, 5037881166834; 635022PE, 635022PE-B, 5037881166629; 631224PE, 631224PE-B, 5037881166902; 632412P50E, 632412P50E-B, 5037881167053; 631507PE, 631507PE-B, 5037881166810; 633014PE, 633014PE-B, 5037881166735; 632010P50E, 632010P50E-B, 5037881167039; 635020PE, 635020PE-B, 5037881166612; 631809P50E, 631809P50E-B, 5037881167022.  All Gelweave devices (any item number ending  E-B  e.g. 7320128/10RMEE-B); REF, Item Number, UDI-DI(GTIN): 736038E, 736038E-B, 5037881169415; 736036E, 736036E-B, 5037881169408; 736034E, 736034E-B, 5037881169392; 736032ST/10DE, 736032ST/10DE-B, 5037881172620; 736032E, 736032E-B, 5037881169385; 736030ST/10DE, 736030ST/10DE-B, 5037881172637; 736030E , 736030E-B, 5037881169378; 736028ST/10DE, 736028ST/10DE-B, 5037881172644; 736028E, 736028E-B, 5037881169361; 736026ST/10DE, 736026ST/10DE-B, 5037881172651; 736026E, 736026E-B, 5037881169354; 736024ST/10DE, 736024ST/10DE-B, 5037881172668; 736024E, 736024E-B, 5037881169347; 736022ST/10DE, 736022ST/10DE-B, 5037881172675; 736022E, 736022E-B, 5037881169330; 736020E, 736020E-B, 5037881169323; 736018E, 736018E-B, 5037881169316; 736016E, 736016E-B, 5037881114057; 736014E, 736014E-B, 5037881114040; 736012E, 736012E-B, 5037881168548; 736010E, 736010E-B, 5037881168517; 736008E, 736008E-B, 5037881168494; 736006E, 736006E-B, 5037881166056; 735034ST/8AE, 735034ST/8AE-B, 5037881173061; 735034/8RME, 735034/8RME-B, 5037881170039; 735034/10SEE, 735034/10SEE-B, 5037881171883; 735034/10RME, 735034/10RME-B, 5037881169958; 735032STE, 735032STE-B, 5037881175102; 735032ST/8AE, 735032ST/8AE-B, 5037881173078; 735032/8SE, 735032/8SE-B, 5037881172095; 735032/8RME, 735032/8RME-B, 5037881170046; 735032/10SEE, 735032/10SEE-B, 5037881171890; 735032/10RME, 735032/10RME-B, 5037881169965; 735030STE, 735030STE-B, 5037881175126; 735030ST/8AE, 735030ST/8AE-B, 5037881173085; 735030/8SE, 735030/8SE-B, 5037881172101; 735030/8RME, 735030/8RME-B, 5037881170053; 735030/10SEE, 735030/10SEE-B, 5037881171906; 735030/10RME, 735030/10RME-B, 5037881169972; 735028STE, 735028STE-B, 5037881175133; 735028ST/8AE, 735028ST/8AE-B, 5037881173092; 735028E, 735028E-B 5037881168876; 735028/8SE, 735028/8SE-B, 5037881172118; 735028/8RME, 735028/8RME-B, 5037881170060; 735028/10RME, 735028/10RME-B, 5037881169989; 735026STE, 735026STE-B, 5037881175140; 735026ST/8AE, 735026ST/8AE-B, 5037881173108; 735026E, 735026E-B, 5037881168869; 735026/8SE, 735026/8SE-B, 5037881172125; 735026/8RME, 735026/8RME-B, 5037881170077; 735026/10RME, 735026/10RME-B, 5037881169996; 735024STE, 735024STE-B, 5037881175164; 735024ST/8AE, 735024ST/8AE-B, 5037881173115; 735024E, 735024E-B, 5037881168845; 735024/8SE, 735024/8SE-B, 5037881172132; 735024/8RME, 735024/8RME-B, 5037881170084; 735024/10SEE, 735024/10SEE-B, 5037881171937; 735024/10RME, 735024/10RME-B, 5037881170008; 735022STE, 735022STE-B, 5037881175188; 735022E, 735022E-B, 5037881168838; 735022/8SE, 735022/8SE-B, 5037881172149; 735022/8RME, 735022/8RME-B, 5037881170091; 735020E, 735020E-B, 5037881168821; 735020/8RME, 735020/8RME-B, 5037881170107; 735018E, 735018E-B, 5037881168814; 734038E, 734038E-B, 5037881169309; 734036E, 734036E-B, 5037881169293; 734034E, 734034E-B, 5037881169286; 734034CX4RMSE, 734034CX4RMSE-B, 5037881170794; 734034/8E, 734034/8E-B, 5037881172460; 734034/10E, 734034/10E-B, 5037881172224; 734032E, 734032E-B, 5037881169279; 734032CX4RMSE, 734032CX4RMSE-B, 5037881170800; 734032/8E, 734032/8E-B, 5037881172477; 734032/10E, 734032/10E-B, 5037881172231; 734030E, 734030E-B, 5037881169262; 734030CX4RMSE, 734030CX4RMSE-B, 5037881170817; 734030/8E, 734030/8E-B, 5037881172484; 734030/10E, 734030/10E-B, 5037881172262; 734028CX4RMSE, 734028CX4RMSE-B, 5037881170824; 734028/8E, 734028/8E-B, 5037881172491; 734028/10E, 734028/10E-B, 5037881172286; 734026CX4RMSE, 734026CX4RMSE-B, 5037881170831; 734026/8E, 734026/8E-B, 5037881172507; 734026/10E, 734026/10E-B, 5037881172309; 734024CX4RMSE, 734024CX4RMSE-B, 5037881170848; 734024/8E, 734024/8E-B, 5037881172514; 734024/10E, 734024/10E-B, 5037881172323; 734022CX4RMSE, 734022CX4RMSE-B, 5037881170855; 734022/8E, 734022/8E-B, 5037881172521; 734022/10E, 734022/10E-B, 5037881172347; 734020CX4RMSE, 734020CX4RMSE-B, 5037881170862; 734020/8E, 734020/8E-B, 5037881172538; 734020/10E, 734020/10E-B, 5037881172354; 734018/8E, 734018/8E-B, 5037881172545; 73341088E, 73341088E-B, 5037881171562; 73341088/8RME, 73341088/8RME-B, 5037881169873; 73341088/8E, 73341088/8E-B, 5037881171371; 73341088/10RME, 73341088/10RME-B, 5037881169774; 73341088/10E, 73341088/10E-B, 5037881171296; 73321488/8ARME, 73321488/8ARME-B, 5037881171043; 7332148/10RMFE, 7332148/10RMFE-B, 5037881174136; 7332148/10RMEE, 7332148/10RMEE-B, 5037881174334; 733212810/10STDE, 733212810/10STDE-B, 5037881172552; 7332128/10RMFE, 7332128/10RMFE-B, 5037881174266; 7332128/10RMEE, 7332128/10RMEE-B, 5037881174433; 73321088E, 73321088E-B, 5037881171579; 73321088/8SDE, 73321088/8SDE-B, 5037881172699; 73321088/8RME, 73321088/8RME-B, 5037881169880; 73321088/8E, 73321088/8E-B, 5037881171388; 73321088/10RME, 73321088/10RME-B, 5037881169781; 73321088/10E, 73321088/10E-B, 5037881171302; 7330888/8E, 7330888/8E-B, 5037881170657; 7330668/6E, 7330668/6E-B, 5037881170718; 733038E, 733038E-B, 5037881169163; 733036E , 733036E-B, 5037881169156; 733034E, 733034E-B, 5037881169149; 733032E, 733032E-B, 5037881169132; 733030E, 733030E-B, 5037881169118; 733028E, 733028E-B, 5037881169101; 733026E, 733026E-B, 5037881169095; 733024E, 733024E-B, 5037881169088; 733024/6AE, 733024/6AE-B, 5037881171845; 733022E, 733022E-B, 5037881169071; 733022/6AE, 733022/6AE-B, 5037881171852; 733020E, 733020E-B, 5037881169064; 733020/6AE, 733020/6AE-B, 5037881171869; 733018E, 733018E-B, 5037881169057; 733018/6AE, 733018/6AE-B, 5037881171876; 733016E, 733016E-B, 5037881168715; 733014E, 733014E-B, 5037881168708; 73301488/8ARME, 73301488/8ARME-B, 5037881171050; 7330148/10RMFE, 7330148/10RMFE-B, 5037881174150; 7330148/10RMEE, 7330148/10RMEE-B, 5037881174358; 73301412/10ETE, 73301412/10ETE-B, 5037881170206; 733012E, 733012E-B, 5037881168692; 733012810/10STDE, 733012810/10STDE-B, 5037881172569; 7330128/10RMFE, 7330128/10RMFE-B, 5037881174273; 7330128/10RMEE, 7330128/10RMEE-B, 5037881174440; 733010E, 733010E-B, 5037881168678; 73301088E, 73301088E-B, 5037881171586; 73301088/8SDE, 73301088/8SDE-B, 5037881172705; 73301088/8RME, 73301088/8RME-B, 5037881169897; 73301088/8E, 73301088/8E-B, 5037881171395; 73301088/10RME, 73301088/10RME-B, 5037881169811; 73301088/10E, 73301088/10E-B, 5037881171319; 733010108/8S4E, 733010108/8S4E-B, 5037881170589; 733010108/8RME, 733010108/8RME-B, 5037881169576; 733010/10RME, 733010/10RME-B, 5037881169729; 733008E, 733008E-B, 5037881168654; 733006E, 733006E-B, 5037881168616; 7328888/8E, 7328888/8E-B, 5037881170664; 7328668/6E, 7328668/6E-B, 5037881170725; 73281488/8ARME, 73281488/8ARME-B, 5037881171067; 7328148/10RMEE, 7328148/10RMEE-B, 5037881174365; 73281412/10ETE, 73281412/10ETE-B, 5037881170213; 73281288/8E, 73281288/8E-B, 5037881171289; 732812810/10STDE, 732812810/10STDE-B, 5037881172576; 7328128/10RMFE, 7328128/10RMFE-B, 5037881174280; 7328128/10RMEE, 7328128/10RMEE-B, 5037881174457; 73281088E, 73281088E-B, 5037881171593; 73281088/8SDE, 73281088/8SDE-B, 5037881172712; 73281088/8RME, 73281088/8RME-B, 5037881169903; 73281088/8E, 73281088/8E-B, 5037881171401; 73281088/10RME, 73281088/10RME-B, 5037881169828; 73281088/10E, 73281088/10E-B, 5037881171326; 732810108/8S4E, 732810108/8S4E-B, 5037881170596; 7326888/8E, 7326888/8E-B, 5037881170671; 7326668/6E, 7326668/6E-B, 5037881170732; 73261488/8ARME, 73261488/8ARME-B, 5037881171074; 7326148/10RMEE, 7326148/10RMEE-B, 5037881174372; 732612810/10STDE, 732612810/10STDE-B, 5037881172583; 7326128/10RMFE, 7326128/10RMFE-B, 5037881174297; 7326128/10RMEE, 7326128/10RMEE-B, 5037881174464; 73261088E, 73261088E-B, 5037881171609; 73261088/8SDE, 73261088/8SDE-B, 5037881172729; 73261088/8RME, 73261088/8RME-B, 5037881169910; 73261088/8E, 73261088/8E-B, 5037881171418; 73261088/10RME, 73261088/10RME-B, 5037881169835; 73261088/10E, 73261088/10E-B, 5037881171333; 732610108/8S4E, 732610108/8S4E-B, 5037881170602; 732610/10RME, 732610/10RME-B, 5037881169743; 732528E, 732528E-B, 5037881168982; 732526E, 732526E-B, 5037881168975; 732524E, 732524E-B, 5037881168968; 732522E, 732522E-B, 5037881168951; 732520E, 732520E-B, 5037881168944; 732518E, 732518E-B, 5037881168937; 7324888/8E, 7324888/8E-B, 5037881170688; 7324668/6E, 7324668/6E-B, 5037881170749; 73241488/8ARME, 73241488/8ARME-B, 5037881171081; 7324148/10RMEE, 7324148/10RMEE-B, 5037881174389; 732412E, 732412E-B, 5037881174907; 732412810/10STDE, 732412810/10STDE-B, 5037881172590; 7324128/10RMEE, 7324128/10RMEE-B, 5037881174495; 732412/6E, 732412/6E-B, 5037881174983; 73241088E, 73241088E-B, 5037881171616; 73241088/8SDE, 73241088/8SDE-B, 5037881172736; 73241088/8RME, 73241088/8RME-B, 5037881169927; 73241088/8E, 73241088/8E-B, 5037881171425; 73241088/10RME, 73241088/10RME-B, 5037881169842; 73241088/10E, 73241088/10E-B, 5037881171340; 732410108/8S4E, 732410108/8S4E-B, 5037881170619; 73221488/8ARME, 73221488/8ARME-B, 5037881171098; 732214/10/10CRME, 732214/10/10CRME-B, 5037881171661; 732212810/10STDE, 732212810/10STDE-B, 5037881172606; 732212/10/8CRME, 732212/10/8CRME-B, 5037881171678; 732212/10/8ARME, 732212/10/8ARME-B, 5037881171692; 732211E, 732211E-B, 5037881174839; 73221088/8RME, 73221088/8RME-B, 5037881169934; 73221088/8E, 73221088/8E-B, 5037881171432; 73221088/10E, 73221088/10E-B, 5037881171357; 732210108/8S4E, 732210108/8S4E-B, 5037881170626; 7320888/8E, 7320888/8E-B, 5037881170701; 7320668/6E, 7320668/6E-B, 5037881170763; 732038E, 732038E-B, 5037881169255; 732034E, 732034E-B, 5037881169248; 732034CX4RME, 732034CX4RME-B, 5037881170879; 732034/8E, 732034/8E-B, 5037881172392; 732034/10E, 732034/10E-B, 5037881172156; 732032E, 732032E-B, 5037881169231; 732032CX4RME, 732032CX4RME-B, 5037881170886; 732032/8E, 732032/8E-B, 5037881172408; 732032/10E, 732032/10E-B, 5037881172163; 732030E, 732030E-B, 5037881169224; 732030CX4RME, 732030CX4RME-B, 5037881170893; 732030/8E, 732030/8E-B, 5037881172415; 732030/10E, 732030/10E-B, 5037881172170; 732028CX4RME, 732028CX4RME-B, 5037881170909; 732028/8E, 732028/8E-B, 5037881172422; 732028/10E, 732028/10E-B, 5037881172187; 732026CX4RME, 732026CX4RME-B, 5037881170916; 732026/8E, 732026/8E-B, 5037881172439; 732026/10E, 732026/10E-B, 5037881172194; 732024CX4RME, 732024CX4RME-B, 5037881170923; 732024/8E, 732024/8E-B, 5037881172446; 732024/10E, 732024/10E-B, 5037881172200; 732022/10E, 732022/10E-B, 5037881172217; 732014/8X2E, 732014/8X2E-B, 5037881171739; 732014/8X2AE, 732014/8X2AE-B, 5037881176277; 732014/10X2E, 732014/10X2E-B, 5037881171722; 732014/10X2AE, 732014/10X2AE-B, 5037881175355; 732012810/10STDE, 732012810/10STDE-B, 5037881172613; 732012/8X2E, 732012/8X2E-B, 5037881171753; 732012/8X2AE, 732012/8X2AE-B, 5037881175324; 732012/10X2E, 732012/10X2E-B, 5037881171746; 732010E, 732010E-B, 5037881174822; 73201088/8RME, 73201088/8RME-B, 5037881169941; 73201088/8E, 73201088/8E-B, 5037881171449; 732010108/8S4E, 732010108/8S4E-B, 5037881170633; 732010/6E, 732010/6E-B, 5037881174976; 731809E, 731809E-B, 5037881174792; 731809/6E, 731809/6E-B, 5037881174945; 731608XL55E, 731608XL55E-B, 5037881175348; 731608E, 731608E-B, 5037881174747; 731608/8/10RME, 731608/8/10RME-B, 5037881175195; 731608/6E, 731608/6E-B, 5037881174921; 731608/10/10RME, 731608/10/10RME-B, 5037881175201; 731516E, 731516E-B, 5037881168807; 731514E, 731514E-B, 5037881168791; 731512E, 731512E-B, 5037881168784; 731510E, 731510E-B, 5037881168760; 731508E, 731508E-B, 5037881168746; 731506E, 731506E-B, 5037881168722; 7314108/10RME, 7314108/10RME-B, 5037881176468; 731407XL55E, 731407XL55E-B, 5037881175362; 731407E, 731407E-B, 5037881174686; 731407/7E, 731407/7E-B, 5037881175119; 731407/10/10RME, 731407/10/10RME-B, 5037881175218; 731228E, 731228E-B, 5037881169040; 731226E, 731226E-B, 5037881169033; 731224E, 731224E-B, 5037881169026; 731222E, 731222E-B, 5037881169019; 731220E, 731220E-B, 5037881169002; 731218E, 731218E-B, 5037881168999; 7312108/10RME, 7312108/10RME-B, 5037881176444; 731210/8X2E, 731210/8X2E-B, 5037881171456; 731206XL55E, 731206XL55E-B, 5037881175379; 731206E, 731206E-B, 5037881174631; 731206/10/10RME, 731206/10/10RME-B, 5037881175225; 731038E, 731038E-B, 5037881169217; 731036E, 731036E-B, 5037881169200; 731034E, 731034E-B, 5037881169194; 731032E, 731032E-B, 5037881169187; 731030E, 731030E-B, 5037881169170; 731010/8X2E, 731010/8X2E-B, 5037881171463; 730034ADPE, 730034ADPE-B, 5037881173986; 730032ADPSLE, 730032ADPSLE-B, 5037881173603; 730032ADPE, 730032ADPE-B, 5037881173993; 730030ADPSLE, 730030ADPSLE-B, 5037881173634; 730030ADPE, 730030ADPE-B, 5037881174013; 730028ADPSLE, 730028ADPSLE-B, 5037881173641; 730028ADPE, 730028ADPE-B, 5037881174037; 730026ADPE, 730026ADPE-B, 5037881174044; 730024ADPE, 730024ADPE-B, 5037881174051; 730022ADPE, 730022ADPE-B, 5037881174068; 730020ADPE, 730020ADPE-B, 5037881174082; 730018ADPE, 730018ADPE-B, 5037881174099; 730016ADPE, 730016ADPE-B, 5037881174112.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2026%22", "url": "https://recallledger.net/recalls/device-z-1492-2026-gelsoft-plus-ref-635024pe-631514pe-631222pe-633008pe-633010pe-6/"}, {"id": "fda-drug-d-0352-2026", "source": "FDA", "category": "drug", "recall_number": "D-0352-2026", "title": "BioGlo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)", "product": "BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "184,320 containers", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0352-2026%22", "url": "https://recallledger.net/recalls/drug-d-0352-2026-bioglo-fluorescein-sodium-ophthalmic-strips-usp-100-diagnostic-strips/"}, {"id": "fda-drug-d-0351-2026", "source": "FDA", "category": "drug", "recall_number": "D-0351-2026", "title": "Bio Glo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)", "product": "Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III,  Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "50,400 Boxes", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0351-2026%22", "url": "https://recallledger.net/recalls/drug-d-0351-2026-bio-glo-fluorescein-sodium-ophthalmic-strips-usp-300-diagnostic-strip/"}, {"id": "fda-drug-d-0350-2026", "source": "FDA", "category": "drug", "recall_number": "D-0350-2026", "title": "CHNaO Fluorescein Sodium Ophthalmic Strips recall (Wizcure Pharmaa Private Limited)", "product": "CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30.  Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "10,080 boxes", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2026%22", "url": "https://recallledger.net/recalls/drug-d-0350-2026-chnao-fluorescein-sodium-ophthalmic-strips-usp-1mg-packaged-as-a-10/"}, {"id": "fda-drug-d-0349-2026", "source": "FDA", "category": "drug", "recall_number": "D-0349-2026", "title": "Vista Gonio Eye Lubricant recall (Wizcure Pharmaa Private Limited)", "product": "Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "139,104 cartons", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0349-2026%22", "url": "https://recallledger.net/recalls/drug-d-0349-2026-vista-gonio-eye-lubricant-hypromellose-ophthalmic-solution-usp-steri/"}, {"id": "fda-drug-d-0348-2026", "source": "FDA", "category": "drug", "recall_number": "D-0348-2026", "title": "Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... recall (Wizcure Pharmaa Private Limited)", "product": "Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "11,520 cartons", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2026%22", "url": "https://recallledger.net/recalls/drug-d-0348-2026-vista-meibo-tears-propylene-glycol-0-6-w-v-eye-drops-advanced-dry-eye/"}, {"id": "fda-drug-d-0347-2026", "source": "FDA", "category": "drug", "recall_number": "D-0347-2026", "title": "Vista Gel Hypromellose USP 0.3% w/v recall (Wizcure Pharmaa Private Limited)", "product": "Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "17,280 cartons", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0347-2026%22", "url": "https://recallledger.net/recalls/drug-d-0347-2026-vista-gel-hypromellose-usp-0-3-w-v-eye-drops-dry-eye-relief-lubricat/"}, {"id": "fda-drug-d-0346-2026", "source": "FDA", "category": "drug", "recall_number": "D-0346-2026", "title": "Vista Tears Polyethylene Glycol 400 0.4% w/v recall (Wizcure Pharmaa Private Limited)", "product": "Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.", "reason": "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.", "hazard_level": "Class II", "company": "Wizcure Pharmaa Private Limited", "company_location": "Bhiwadi, N/A, India", "date": "2025-12-31", "report_date": "2026-03-04", "status": "Ongoing", "distribution": "Distributed Nationwide in the USA", "states": [], "nationwide": true, "quantity": "5,760 cartons", "codes": "All lots", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0346-2026%22", "url": "https://recallledger.net/recalls/drug-d-0346-2026-vista-tears-polyethylene-glycol-400-0-4-w-v-propylene-glycol-0-3-w/"}, {"id": "fda-device-z-1426-2026", "source": "FDA", "category": "device", "recall_number": "Z-1426-2026", "title": "Brand Name: Prodisc  Product Name: Prodisc C SK  Model/Catalog Number: PDSL6  Software... recall (Centinel Spine, Inc.)", "product": "Brand Name: Prodisc  Product Name: Prodisc C SK  Model/Catalog Number: PDSL6  Software Version: N/A  Product Description: Total cervical disc replacement  Component: No", "reason": "Products were mislabeled as the 6mm product but included the 5 mm product.", "hazard_level": "Class II", "company": "Centinel Spine, Inc.", "company_location": "West Chester, PA, United States", "date": "2025-12-31", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.", "states": ["AL", "CA", "CO", "LA", "NY", "OR", "TN", "TX"], "nationwide": true, "quantity": "20 units", "codes": "Model Number: PDSL6;  UDI-DI 00843193113924;  Lot 2025-0776;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2026%22", "url": "https://recallledger.net/recalls/device-z-1426-2026-brand-name-prodisc-product-name-prodisc-c-sk-model-catalog-number/"}, {"id": "fda-device-z-1370-2026", "source": "FDA", "category": "device", "recall_number": "Z-1370-2026", "title": "Medica Capillary Tubes recall (Medica Corporation)", "product": "Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.", "reason": "A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.", "hazard_level": "Class II", "company": "Medica Corporation", "company_location": "Bedford, MA, United States", "date": "2025-12-31", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "International distribution to the countries of Russia, Bulgaria, Kazakhstan, Ukraine, Pakistan, Belarus.", "states": [], "nationwide": false, "quantity": "1,578 units", "codes": "Model No. 7303, UDI-DI: 00840095607575, Lot No. 25XXX.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1370-2026%22", "url": "https://recallledger.net/recalls/device-z-1370-2026-medica-capillary-tubes-easybloodgas-easystat-capillary-tube-kit/"}, {"id": "fda-device-z-1369-2026", "source": "FDA", "category": "device", "recall_number": "Z-1369-2026", "title": "Estrone RIA recall (Immunotech A.S.)", "product": "Estrone RIA, REF: DSL8700", "reason": "The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.", "hazard_level": "Class II", "company": "Immunotech A.S.", "company_location": "Prague 10, Czech Republic", "date": "2025-12-15", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.", "states": ["NC"], "nationwide": true, "quantity": "160", "codes": "UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1369-2026%22", "url": "https://recallledger.net/recalls/device-z-1369-2026-estrone-ria-ref-dsl8700/"}, {"id": "fda-device-z-1367-2026", "source": "FDA", "category": "device", "recall_number": "Z-1367-2026", "title": "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth... recall (Bard Peripheral Vascular Inc)", "product": "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060", "reason": "Due to damage to outer tray that can potentially compromise the sterile barrier", "hazard_level": "Class II", "company": "Bard Peripheral Vascular Inc", "company_location": "Tempe, AZ, United States", "date": "2025-12-12", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states of 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of  Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.", "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", "NE", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV"], "nationwide": true, "quantity": "14,935 units", "codes": "Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547  Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312  Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274  Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310  Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316  Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0327 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0327 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285  Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600540 UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKV0560 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKV0560 HUKW0156 HUKW0159  Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600560 UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0376 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0376 HUKV0555  Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600570 UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0569 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKV0581 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0569 HUKV0576 HUKV0581 HUKW0148  Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600620 UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534  Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600650 UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283  Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 606560 UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315  Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600100CE UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312  Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600310CE UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310  Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600520CE UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285  Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600540CE UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKW0156 HUKW0159  Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600560CE UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0555  Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600570CE UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0576 HUKW0148  Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600620CE UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534  Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600650CE UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283  Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0606560CE UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1367-2026%22", "url": "https://recallledger.net/recalls/device-z-1367-2026-broviac-4-2-fr-single-lumen-cv-catheter-cutdown-tray-with-surecuff-tis/"}, {"id": "fda-device-z-1366-2026", "source": "FDA", "category": "device", "recall_number": "Z-1366-2026", "title": "Medline Industries IV Administration and Extension Sets:  1) DBD-IV ADMIN SET recall (Medline Industries, LP)", "product": "Medline Industries IV Administration and Extension Sets:  1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529;   2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029;   3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516;   4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530;   5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539;   6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545;   7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045;   8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512;   9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555;   10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022;   11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512;   12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529;   13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537;   14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540;   15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029;   16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077;   17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045;   18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D;   19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524;   20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012;   21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012;   22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022;   23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081", "reason": "Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use,  which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-31", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Bahamas.", "states": [], "nationwide": true, "quantity": "926,227 units", "codes": "1) DYNDTB0529, UDI-DI: 10197344105663(each), 20197344105660(case), Lot Number: All Lot Numbers; 2) DYNDTB1029, UDI-DI: 10197344076956(each), 20197344076953(case), Lot Number: All Lot Numbers; 3) DYNDTB1516, UDI-DI: 10197344105687(each), 20197344105684(case), Lot Number: All Lot Numbers; 4) DYNDTB1530, UDI-DI: 10197344105694(each), 20197344105691(case), Lot Number: All Lot Numbers; 5) DYNDTB1539, UDI-DI: 10197344008254(each), 20197344008251(case), Lot Number: All Lot Numbers; 6) DYNDTB1545, UDI-DI: 10197344098644(each), 20197344098641(case), Lot Number: All Lot Numbers; 7) DYNDTB2045, UDI-DI: 10197344077007(each), 20197344077004(case), Lot Number: All Lot Numbers; 8) DYNDTB0512, UDI-DI: 10197344105656(each), 20197344105653(case), Lot Number: All Lot Numbers; 9) DYNDTB0555, UDI-DI: 10197344105670(each), 20197344105677(case), Lot Number: All Lot Numbers; 10) DYNDTB1022, UDI-DI: 10197344076949(each), 20197344076946(case), Lot Number: All Lot Numbers; 11) DYNDTB1512, UDI-DI: 10197344098613(each), 20197344098610(case), Lot Number: All Lot Numbers; 12) DYNDTB1529, UDI-DI: 10197344098620(each), 20197344098627(case), Lot Number: All Lot Numbers; 13) DYNDTB1537, UDI-DI: 10197344008247(each), 20197344008244(case), Lot Number: All Lot Numbers; 14) DYNDTB1540, UDI-DI: 10197344098637(each), 20197344098634(case), Lot Number: All Lot Numbers; 15) DYNDTB2029, UDI-DI: 10197344076994(each), 20197344076991(case), Lot Number: All Lot Numbers; 16) DYNDTB5077, UDI-DI: 10197344098651(each), 20197344098658(case), Lot Number: All Lot Numbers; 17) DYNDTB1045, UDI-DI: 10197344076963(each), 20197344076960(case), Lot Number: All Lot Numbers; 18) DYNDTB1545D, UDI-DI: 10197344105700(each), 20197344105707(case), Lot Number: All Lot Numbers; 19) DYNDTB2524, UDI-DI: 10197344105717(each), 20197344105714(case), Lot Number: All Lot Numbers; 20) DYNDTB1012, UDI-DI: 10197344076932(each), 20197344076939(case), Lot Number: All Lot Numbers; 21) DYNDTB2012, UDI-DI: 10197344076970(each), 20197344076977(case), Lot Number: All Lot Numbers; 22) DYNDTB2022, UDI-DI: 10197344076987(each), 20197344076984(case), Lot Number: All Lot Numbers; 23) DYNDTB5081, UDI-DI: 10197344098668(each), 20197344098665(case), Lot Number: All Lot Numbers", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1366-2026%22", "url": "https://recallledger.net/recalls/device-z-1366-2026-medline-industries-iv-administration-and-extension-sets-1-dbd-iv-ad/"}, {"id": "fda-device-z-1362-2026", "source": "FDA", "category": "device", "recall_number": "Z-1362-2026", "title": "Teslatome Bipolar Sphincterotomes  REF: TESLA-B2535-260  Model Number: G60784  UDI-DI... recall (Wilson-Cook Medical Inc.)", "product": "Teslatome Bipolar Sphincterotomes  REF: TESLA-B2535-260  Model Number: G60784  UDI-DI code: 00827002607842    REF: TESLA-B2535-450  Model Number: G60785  UDI-DI code: 00827002607859    These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.", "reason": "Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.", "hazard_level": "Class II", "company": "Wilson-Cook Medical Inc.", "company_location": "Winston Salem, NC, United States", "date": "2025-12-18", "report_date": "2026-02-25", "status": "Ongoing", "distribution": "U.S. Distribution to states of: CA, CO, IN, and NC.", "states": ["CA", "CO", "IN", "NC"], "nationwide": false, "quantity": "153", "codes": "RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 /  TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260  REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1362-2026%22", "url": "https://recallledger.net/recalls/device-z-1362-2026-teslatome-bipolar-sphincterotomes-ref-tesla-b2535-260-model-number/"}, {"id": "fda-device-z-1355-2026", "source": "FDA", "category": "device", "recall_number": "Z-1355-2026", "title": "da Vinci 5 Surgeon Console Viewer Display recall (Intuitive Surgical, Inc.)", "product": "da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45", "reason": "Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-30", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.", "states": ["AZ", "CA", "CT", "DC", "FL", "GA", "ID", "IL", "KS", "KY", "MA", "MI", "MN", "MS", "NC", "NV", "NY", "SC", "TX", "UT", "VA", "WI"], "nationwide": true, "quantity": "47", "codes": "UDI: 00886874119747, Serial: SQ0326, SQ0336, SQ0341, SQ0345, SQ0346, SQ0356, SQ0367, SQ0368, SQ0375, SQ0377, SQ0379, SQ0380, SQ0386, SQ0387, SQ0389, SQ0394, SQ0395, SQ0398, SQ0401, SQ0404, SQ0412, SQ0413, SQ0415, SQ0419, SQ0420, SQ0422, SQ0425, SQ0427, SQ0428, SQ0432, SQ0433, SQ0436, SQ0443, SQ0447, SQ0448, SQ0451, SQ0454, SQ0457, SQ0458, SQ0462, SQ0464, SQ0469, SQ0470, SQ0662, SQ0727, SQ0740, SQ0761", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1355-2026%22", "url": "https://recallledger.net/recalls/device-z-1355-2026-da-vinci-5-surgeon-console-viewer-display-assy-dv5-console-is5000/"}, {"id": "fda-device-z-1340-2026", "source": "FDA", "category": "device", "recall_number": "Z-1340-2026", "title": "Brand Name: Leksell GammaPlan  Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)", "product": "Brand Name: Leksell GammaPlan  Product Name: Radionuclide RT Treatment planning system  Software Version: 11,3, 11.4  Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.", "reason": "Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.  This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.", "hazard_level": "Class II", "company": "Elekta, Inc.", "company_location": "Atlanta, GA, United States", "date": "2025-12-12", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.", "states": ["AK", "AZ", "CA", "CO", "FL", "GA", "HI", "IA", "IL", "LA", "MA", "MI", "MN", "MO", "NC", "NJ", "NM", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV"], "nationwide": true, "quantity": "N/A", "codes": "Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1340-2026%22", "url": "https://recallledger.net/recalls/device-z-1340-2026-brand-name-leksell-gammaplan-product-name-radionuclide-rt-treatment/"}, {"id": "fda-device-z-1339-2026", "source": "FDA", "category": "device", "recall_number": "Z-1339-2026", "title": "Brand Name: Leksell GammaPlan  Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)", "product": "Brand Name: Leksell GammaPlan  Product Name: Radionuclide RT Treatment planning system  Software Version: 11.1  Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.", "reason": "Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.  This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.", "hazard_level": "Class II", "company": "Elekta, Inc.", "company_location": "Atlanta, GA, United States", "date": "2025-12-12", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.", "states": ["AK", "AZ", "CA", "CO", "FL", "GA", "HI", "IA", "IL", "LA", "MA", "MI", "MN", "MO", "NC", "NJ", "NM", "NY", "OH", "OK", "OR", "PA", "PR", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV"], "nationwide": true, "quantity": "N/A", "codes": "Lot Code: 07340048311236 (LGP 11.1)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1339-2026%22", "url": "https://recallledger.net/recalls/device-z-1339-2026-brand-name-leksell-gammaplan-product-name-radionuclide-rt-treatment/"}, {"id": "fda-device-z-1336-2026", "source": "FDA", "category": "device", "recall_number": "Z-1336-2026", "title": "Medline medical convenience kits packaged as:  MERCY CIRCUMCISION TRAY recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "168 units", "codes": "UDI/DI 10653160990666, Lot Number 25EBC648", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2026%22", "url": "https://recallledger.net/recalls/device-z-1336-2026-medline-medical-convenience-kits-packaged-as-mercy-circumcision-tray/"}, {"id": "fda-device-z-1335-2026", "source": "FDA", "category": "device", "recall_number": "Z-1335-2026", "title": "Medline medical convenience kits packaged as:  STERILE RESUTURE PACK recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  STERILE RESUTURE PACK, Kit SKU DYNDL1980A", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "216 kits", "codes": "UDI/DI 10195327379292, Lot Number 25EBJ785", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1335-2026%22", "url": "https://recallledger.net/recalls/device-z-1335-2026-medline-medical-convenience-kits-packaged-as-sterile-resuture-pack/"}, {"id": "fda-device-z-1334-2026", "source": "FDA", "category": "device", "recall_number": "Z-1334-2026", "title": "Medline medical convenience kits packaged as:    ) LVAD DRESSING CHANGE TRAY recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:    ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C;   2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A;   3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615;   4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660;   5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665;   6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495;   7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A;   8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B;   9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "8445 kits", "codes": "1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881;  2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827;  3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730;  4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629;  5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086;  6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081;  7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351;  8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085;  9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1334-2026%22", "url": "https://recallledger.net/recalls/device-z-1334-2026-medline-medical-convenience-kits-packaged-as-lvad-dressing-chang/"}, {"id": "fda-device-z-1333-2026", "source": "FDA", "category": "device", "recall_number": "Z-1333-2026", "title": "Medline medical convenience kits packaged as:  BLOOD CULTURE KIT NS recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  BLOOD CULTURE KIT NS, Kit SKU DYNDH2088", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "4300 kits", "codes": "UDI/DI 10198459230363, Lot Numbers:  25EBU508, 25EBE330.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1333-2026%22", "url": "https://recallledger.net/recalls/device-z-1333-2026-medline-medical-convenience-kits-packaged-as-blood-culture-kit-ns-k/"}, {"id": "fda-device-z-1332-2026", "source": "FDA", "category": "device", "recall_number": "Z-1332-2026", "title": "Medline medical convenience kits packaged as:  SUTURE REMOVAL TRAY recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "2448 kits", "codes": "UDI/DI 10195327379308, Lot Number 25EBO576", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1332-2026%22", "url": "https://recallledger.net/recalls/device-z-1332-2026-medline-medical-convenience-kits-packaged-as-suture-removal-tray-ki/"}, {"id": "fda-device-z-1331-2026", "source": "FDA", "category": "device", "recall_number": "Z-1331-2026", "title": "Medline medical convenience kits packaged as:    1) POWERGLIDE DRESSING CHANGE KIT recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:    1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576;   2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "7380 kits", "codes": "1) Kit SKU DYNDH1576, UDI/DI 10193489437041, Lot Number 25EBP737;  2) Kit SKU RWM-DC57KC, UDI/DI 10889942582013, Lot Number 25EBE082.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1331-2026%22", "url": "https://recallledger.net/recalls/device-z-1331-2026-medline-medical-convenience-kits-packaged-as-1-powerglide-dressin/"}, {"id": "fda-device-z-1330-2026", "source": "FDA", "category": "device", "recall_number": "Z-1330-2026", "title": "1) UNIVERSAL KIT recall (Medline Industries, LP)", "product": "1) UNIVERSAL KIT, Kit SKU DT22010B;   2) VAD ACCESS KIT, Kit SKU DT22790C;   3) VAD ACCESS KIT, Kit SKU DT22790C;   4) PROCEDURE TRAY, Kit SKU DYNDA2966A;   5) PROCEDURE TRAY, Kit SKU DYNDA2966A;   6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C;   7) PORT DRESSING KIT, Kit SKU DYNDC3107;   8) NON STERILE DIALYSIS KIT, Kit SKU DYNDH1029C;   9) UMBILICAL TRAY W/3.5&5FR CATH, Kit SKU UVT1250;   10) UMBILICAL VESSEL TRAY, Kit SKU UVT835;   11) HEMODIALYSIS TRAY, Kit SKU VAR101HVAA.", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "21854 units", "codes": "1) Kit SKU DT22010B, UDI/DI 10653160351092, Lot number 25EBC888;  2) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBO566;  3) Kit SKU DT22790C, UDI/DI 10653160996965, Lot number 25EBD964;  4) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBN178;  5) Kit SKU DYNDA2966A, UDI/DI 10198459005848, Lot number 25EBL624;  6) Kit SKU DYNDC2208C, UDI/DI 10889942815333, Lot number 25EBC706;  7) Kit SKU DYNDC3107, UDI/DI 10193489917628, Lot number 25EBN742;  8) Kit SKU DYNDH1029C, UDI/DI 10889942816453, Lot number 25EBC778;  9) Kit SKU UVT1250, UDI/DI 10653160995340, Lot number 25EBO757;  10) Kit SKU UVT835, UDI/DI 10653160289180, Lot number 25FMI300;  11) Kit SKU VAR101HVAA, UDI/DI 10193489388145, Lot number 25EBE079.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2026%22", "url": "https://recallledger.net/recalls/device-z-1330-2026-1-universal-kit-kit-sku-dt22010b-2-vad-access-kit-kit-sku-dt227/"}, {"id": "fda-device-z-1329-2026", "source": "FDA", "category": "device", "recall_number": "Z-1329-2026", "title": "Medline medical convenience kits packaged as:    1) CANCER SERVICE PORT KIT recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:    1) CANCER SERVICE PORT KIT, Kit SKU DT22710;   2) LINE KIT, Kit SKU DYNDA1857A;   3) PICC REMOVAL KIT, Kit SKU DYNDC1978A;   4) PORT ACCESS TRAY, Kit SKU DYNDC2367;   5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B;   6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A;   7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A;   8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "7570 kits", "codes": "1) Kit SKU DT22710, Lot Numbers:  25EBC812;  2) Kit SKU DYNDA1857A, Lot Numbers:  25FBH991;  3) Kit SKU DYNDC1978A, Lot Numbers:  25EBC577;  4) Kit SKU DYNDC2367, Lot Numbers:  25EBS434;  5) Kit SKU DYNDC2407B, Lot Numbers:  25FMG170;  6) Kit SKU DYNDC3222A, Lot Numbers:  25EBK184;  7) Kit SKU DYNJ59067A, Lot Numbers:  25EBM461, 25EBD386;  8) Kit SKU PHS950205004B, Lot Numbers:  25FMD059.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1329-2026%22", "url": "https://recallledger.net/recalls/device-z-1329-2026-medline-medical-convenience-kits-packaged-as-1-cancer-service-por/"}, {"id": "fda-device-z-1328-2026", "source": "FDA", "category": "device", "recall_number": "Z-1328-2026", "title": "Medline medical convenience kits packaged as:  PEDIATRIC CATH SECUREMENT DRSG recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "450 kits", "codes": "UDI/DI 10193489918007, Lot Number 25EBD612", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2026%22", "url": "https://recallledger.net/recalls/device-z-1328-2026-medline-medical-convenience-kits-packaged-as-pediatric-cath-secureme/"}, {"id": "fda-device-z-1327-2026", "source": "FDA", "category": "device", "recall_number": "Z-1327-2026", "title": "Medline medical convenience kits packaged as:  ADULT CATH SECUREMENT DRSG recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1350 kits", "codes": "UDI/DI  10193489918113, Lot Number 25EBD613", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1327-2026%22", "url": "https://recallledger.net/recalls/device-z-1327-2026-medline-medical-convenience-kits-packaged-as-adult-cath-securement-d/"}, {"id": "fda-device-z-1326-2026", "source": "FDA", "category": "device", "recall_number": "Z-1326-2026", "title": "Medline medical convenience kits packaged as:  ANESTHESIA ARTLINE PACK recall (Medline Industries, LP)", "product": "Medline medical convenience kits packaged as:  ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B", "reason": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "120 kits", "codes": "UDI/DI 10193489217070, Lot Number 25EBJ414", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1326-2026%22", "url": "https://recallledger.net/recalls/device-z-1326-2026-medline-medical-convenience-kits-packaged-as-anesthesia-artline-pack/"}, {"id": "fda-device-z-1325-2026", "source": "FDA", "category": "device", "recall_number": "Z-1325-2026", "title": "Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:    ACUSON AcuNav... recall (Medline Industries, LP)", "product": "Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:    ACUSON AcuNav Ultrasound Catheter, Use on GE Systems  10135910RH; 10043342RH    ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems  10135936RH, 08255790RH", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "511", "codes": "10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905;  10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1325-2026%22", "url": "https://recallledger.net/recalls/device-z-1325-2026-reprocessed-siemens-acuson-acunav-diagnostic-ultrasound-catheters/"}, {"id": "fda-device-z-1324-2026", "source": "FDA", "category": "device", "recall_number": "Z-1324-2026", "title": "Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:   ... recall (Medline Industries, LP)", "product": "Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems  10439072RH;    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems  10438577RH;    Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems  10439011RH", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "94", "codes": "10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808;  10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808;  10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808;  10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1324-2026%22", "url": "https://recallledger.net/recalls/device-z-1324-2026-reprocessed-biosense-webster-soundstar-eco-diagnostic-ultrasound-cathe/"}, {"id": "fda-device-z-1323-2026", "source": "FDA", "category": "device", "recall_number": "Z-1323-2026", "title": "Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:    ViewFlex Xtra ICE Catheter... recall (Medline Industries, LP)", "product": "Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:    ViewFlex Xtra ICE Catheter 9F x 90cm  D087031RH  20197344019554¿", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "650", "codes": "UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1323-2026%22", "url": "https://recallledger.net/recalls/device-z-1323-2026-medline-renewal-reprocessed-viewflex-xtra-ice-catheters-viewflex-x/"}, {"id": "fda-device-z-1322-2026", "source": "FDA", "category": "device", "recall_number": "Z-1322-2026", "title": "Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:   ... recall (Medline Industries, LP)", "product": "Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "48", "codes": "401211RH UDI-DI 10197344043736 Lot EP250317;  401222RH UDI-DI 10197344043712 Lot EP250317;  401223RH UDI-DI 10197344043705 Lot EP250317;  401226RH UDI-DI 10197344043699 Lot EP250307 EP250317;  401227RH UDI-DI 10197344043682 Lots EP250307 EP250317;  401260RH UDI-DI 10197344043668 Lot EP250317;  401261RH UDI-DI 10197344043651 Lot EP250317;  401306RH UDI-DI 10197344043620¿ Lot EP250317;  401309RH UDI-DI 10197344043613 Lot EP250317;  401312RH UDI-DI 10197344043583¿ Lot EP250307;  401430RH UDI-DI 10197344043491 Lots EP250307 EP250317;  401433RH UDI-DI 10197344043484 Lots EP250307 EP250317;  401435RH UDI-DI 10197344043460 Lots EP250307 EP250317;  401441RH UDI-DI 10197344043439 Lots EP250307 EP250317;  401442RH UDI-DI 10197344044245 Lot EP250307;  401443RH UDI-DI 10197344044252 Lots EP250307 EP250317;  401448RH UDI-DI 10197344044283 Lot EP250307;  401449RH UDI-DI 10197344044290 Lot EP250307;  401450RH UDI-DI 10197344044306 Lots EP250307 EP250317;  401451RH UDI-DI 10197344044313 EP250307 EP250317;  401474RH UDI-DI 10197344044351 Lot EP250307;  401860RH UDI-DI 10197344044382 Lots EP250307 EP250317;  401877RH UDI-DI 10197344044436 Lots EP250307 EP250317;  401878RH UDI-DI 10197344044443 Lot EP250307;  401890RH UDI-DI 10197344044450 Lots EP250307 EP250317;  401891RH UDI-DI 10197344044467 Lot EP250307;  401994RH UDI-DI 10197344044542 Lot EP250317;  402012RH UDI-DI 10197344043835 Lots EP250307 EP250317;  402004RH UDI-DI 10197344044566 Lots EP250307 EP250317;  402010RH UDI-DI 10197344044597 Lots EP250307 EP250317;  402008RH UDI-DI 10197344044573 Lot EP250317;  402009RH UDI-DI 10197344044580 Lots EP250307 EP250317  ***Updated 5/18/26***  LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2026%22", "url": "https://recallledger.net/recalls/device-z-1322-2026-reprocessed-st-jude-supreme-and-response-diagnostic-electrophysiology/"}, {"id": "fda-device-z-1321-2026", "source": "FDA", "category": "device", "recall_number": "Z-1321-2026", "title": "Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters:    Livewire... recall (Medline Industries, LP)", "product": "Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters:    Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm  401582RH  401940RH;    Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm  401904RH;    Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm  401914RH;    Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm  401932RH;    Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm  401652RH;", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "41", "codes": "401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630;  401940RH UDI-DI 10888277407480 Lot EP250618;  401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630;  401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618;  401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630;  401652RH UDI-DI 10888277407572 Lots EP250618 EP250630", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1321-2026%22", "url": "https://recallledger.net/recalls/device-z-1321-2026-reprocessed-livewire-steerable-diagnostic-electrophysiology-catheters/"}, {"id": "fda-device-z-1320-2026", "source": "FDA", "category": "device", "recall_number": "Z-1320-2026", "title": "Reprocessed Abbott Inquiry Steerable Diagnostic Catheters:      Abbott Inquiry... recall (Medline Industries, LP)", "product": "Reprocessed Abbott Inquiry Steerable Diagnostic Catheters:      Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm  81105RH  81172RH;    Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm  81202RH;    Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm  81483RH;    Inquiry Steerable  Diagnostic Catheter 10  Elec. 2-5-2mm  81102RH  81104RH  81174RH  81531RH  81532RH;    Inquiry Steerable  Diagnostic Catheter 10  Elec. 5mm  81107RH;    Inquiry Steerable  Diagnostic Catheter 4  Elec. 2-5-2mm  81402RH  81404RH  81405RH  81474RH;    Inquiry Steerable  Diagnostic Catheter 4  Elec. 5mm  81473RH", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "311", "codes": "81105RH UDI-DI 10197344133253 Lot EP250618;  81172RH UDI-DI 10197344133284 Lot EP250618;  81202RH UDI-DI 10197344133307 Lot EP250618;  81483RH UDI-DI 10197344133444 Lot EP250618;  81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618;  81104RH UDI-DI 10197344133246 Lot EP250618;  81174RH UDI-DI 10197344133291 Lot  EP250618;  81531RH UDI-DI 10197344133512 Lot  EP250618;  81532RH UDI-DI 10197344133529 Lot EP250618;  81107RH UDI-DI 10197344133260 Lot EP250618;  81402RH UDI-DI 10197344133352 Lot EP250618;  81404RH UDI-DI 10197344133376 Lot EP250618;  81405RH UDI-DI 10197344133383 Lot EP250618;  81474RH UDI-DI 10197344133437 Lot EP250618;  81473RH UDI-DI 10197344133420 Lot EP250618", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1320-2026%22", "url": "https://recallledger.net/recalls/device-z-1320-2026-reprocessed-abbott-inquiry-steerable-diagnostic-catheters-abbott/"}, {"id": "fda-device-z-1319-2026", "source": "FDA", "category": "device", "recall_number": "Z-1319-2026", "title": "Medline ReNewal Reprocessed Webster CS Catheters:    Webster CS Catheter 10 Electrodes... recall (Medline Industries, LP)", "product": "Medline ReNewal Reprocessed Webster CS Catheters:    Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer  BD710DF282CRH;  Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer  BD710DF282RRH  BD710FJ282RRH;  Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer  BD710FJ282CRH;", "reason": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025", "hazard_level": "Class I", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide.", "states": [], "nationwide": true, "quantity": "228", "codes": "BD710DF282CRH UDI-DI 10197344044023 Lots EP250429 EP250808;  BD710DF282RRH UDI-DI 10197344044030 Lots  EP250429 EP250808;  BD710FJ282RRH UDI-DI 10197344044054 Lots EP250429 EP250808;  BD710FJ282CRH UDI-DI (case) 40197344044048 (ea) 10197344044047 Lots  EP250429 EP250808", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1319-2026%22", "url": "https://recallledger.net/recalls/device-z-1319-2026-medline-renewal-reprocessed-webster-cs-catheters-webster-cs-cathet/"}, {"id": "fda-device-z-1314-2026", "source": "FDA", "category": "device", "recall_number": "Z-1314-2026", "title": "Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)", "product": "Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.", "reason": "Presence of particulates in affected devices that can be deposited into breast tissue during use.", "hazard_level": "Class II", "company": "Hologic, Inc", "company_location": "Marlborough, MA, United States", "date": "2025-12-15", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "681,870 units", "codes": "Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2026%22", "url": "https://recallledger.net/recalls/device-z-1314-2026-brevera-breast-biopsy-system-disposable-9-gauge-needle-biopsy-instrum/"}, {"id": "fda-device-z-1313-2026", "source": "FDA", "category": "device", "recall_number": "Z-1313-2026", "title": "Intubation Tray recall (Medline Industries, LP)", "product": "Intubation Tray (Adult) containing Suction Catheter Kits  SKU DYNJAA245B", "reason": "A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide and Canada.", "states": [], "nationwide": true, "quantity": "130", "codes": "Kit lots 25IBC172 25HBJ413  UDI (ea) 10198459480317 UDI (case) 40198459480318", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1313-2026%22", "url": "https://recallledger.net/recalls/device-z-1313-2026-intubation-tray-adult-containing-suction-catheter-kits-sku-dynjaa24/"}, {"id": "fda-device-z-1312-2026", "source": "FDA", "category": "device", "recall_number": "Z-1312-2026", "title": "Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit recall (Medline Industries, LP)", "product": "Medline 14 Fr Suction Catheter Kits  SKU DYND40972 - respiratory convenience kit", "reason": "A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-24", "report_date": "2026-02-18", "status": "Ongoing", "distribution": "Distribution US nationwide and Canada.", "states": [], "nationwide": true, "quantity": "141,971", "codes": "Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1312-2026%22", "url": "https://recallledger.net/recalls/device-z-1312-2026-medline-14-fr-suction-catheter-kits-sku-dynd40972-respiratory-conve/"}, {"id": "fda-food-h-0501-2026", "source": "FDA", "category": "food", "recall_number": "H-0501-2026", "title": "Swiss Chocolate Cake Mix recall (B.C. Williams Bakery Service, Inc)", "product": "Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags", "reason": "Undeclared Milk Allergen", "hazard_level": "Class I", "company": "B.C. Williams Bakery Service, Inc", "company_location": "Dallas, TX, United States", "date": "2025-12-23", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "95 bags", "codes": "072925-220 and 071825-36", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0501-2026%22", "url": "https://recallledger.net/recalls/food-h-0501-2026-swiss-chocolate-cake-mix-50-lb-multi-wall-kraft-poly-lined-moistur/"}, {"id": "fda-food-h-0500-2026", "source": "FDA", "category": "food", "recall_number": "H-0500-2026", "title": "Bread and Roll Mix recall (B.C. Williams Bakery Service, Inc)", "product": "Bread and Roll Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags", "reason": "Undeclared Milk Allergen", "hazard_level": "Class I", "company": "B.C. Williams Bakery Service, Inc", "company_location": "Dallas, TX, United States", "date": "2025-12-23", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "720 Bags", "codes": "Lot #072225-217 Lot #072225-218 Lot #080325-200 Lot #080325-201 Lot #081625-203 Lot #081625-204 Lot #092225-222 Lot #092225-223 Lot #092225-224 Lot #092225-225 Lot #092225-226 Lot #092225-227 Lot #092225-228 Lot #101725-208 Lot #101725-209", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0500-2026%22", "url": "https://recallledger.net/recalls/food-h-0500-2026-bread-and-roll-mix-50-lb-multi-wall-kraft-poly-lined-moisture-proo/"}, {"id": "fda-food-h-0499-2026", "source": "FDA", "category": "food", "recall_number": "H-0499-2026", "title": "Spice Cake Mix recall (B.C. Williams Bakery Service, Inc)", "product": "Spice Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags", "reason": "Undeclared Milk Allergen", "hazard_level": "Class I", "company": "B.C. Williams Bakery Service, Inc", "company_location": "Dallas, TX, United States", "date": "2025-12-23", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "51- 50lb bags", "codes": "Batch 221", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0499-2026%22", "url": "https://recallledger.net/recalls/food-h-0499-2026-spice-cake-mix-50-lb-multi-wall-kraft-poly-lined-moisture-proof-ba/"}, {"id": "fda-food-h-0484-2026", "source": "FDA", "category": "food", "recall_number": "H-0484-2026", "title": "Willy Pete's Chocolates brand Almond Despair recall (Willy Pete's Chocolate Company LLC)", "product": "Willy Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC:  0 987261 5", "reason": "Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.", "hazard_level": "Class III", "company": "Willy Pete's Chocolate Company LLC", "company_location": "Harwinton, CT, United States", "date": "2025-12-22", "report_date": "2026-02-11", "status": "Terminated", "distribution": "MA, SC, CT", "states": ["CT", "MA", "SC"], "nationwide": false, "quantity": "54 units", "codes": "No additional coding. UPC Codes: 09872615", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0484-2026%22", "url": "https://recallledger.net/recalls/food-h-0484-2026-willy-pete-s-chocolates-brand-almond-despair-dark-chocolate-with-coco/"}, {"id": "fda-food-h-0448-2026", "source": "FDA", "category": "food", "recall_number": "H-0448-2026", "title": "BarbaCuban Havana Gold recall (Prima Foods International, Inc.)", "product": "BarbaCuban Havana Gold, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles. UPC code 7 19660 00097 7", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes:  #233/24  Best by date: 02/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0448-2026%22", "url": "https://recallledger.net/recalls/food-h-0448-2026-barbacuban-havana-gold-net-wt-12-oz-355-ml-packed-in-12-oz-glass/"}, {"id": "fda-food-h-0447-2026", "source": "FDA", "category": "food", "recall_number": "H-0447-2026", "title": "BarbaCuban Cubama White Truffle Sauce recall (Prima Foods International, Inc.)", "product": "BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes:  #233/24  Best by date: 02/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0447-2026%22", "url": "https://recallledger.net/recalls/food-h-0447-2026-barbacuban-cubama-white-truffle-sauce-net-wt-12-oz-355-ml-packed/"}, {"id": "fda-food-h-0446-2026", "source": "FDA", "category": "food", "recall_number": "H-0446-2026", "title": "BarbaCuban Ram Air Red Zesty Ketchup recall (Prima Foods International, Inc.)", "product": "BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes:  #133/25  Best by dates:  11/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0446-2026%22", "url": "https://recallledger.net/recalls/food-h-0446-2026-barbacuban-ram-air-red-zesty-ketchup-net-wt-12-oz-355-ml-12-oz-gla/"}, {"id": "fda-food-h-0445-2026", "source": "FDA", "category": "food", "recall_number": "H-0445-2026", "title": "BarbaCuban 455 Everything Sauce recall (Prima Foods International, Inc.)", "product": "BarbaCuban 455 Everything Sauce (Hot), Net Wt 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00083 0", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes: #190/24, #339/24   Best by dates:  01/2026 through 06/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0445-2026%22", "url": "https://recallledger.net/recalls/food-h-0445-2026-barbacuban-455-everything-sauce-hot-net-wt-12-oz-355-ml-12-oz-gla/"}, {"id": "fda-food-h-0444-2026", "source": "FDA", "category": "food", "recall_number": "H-0444-2026", "title": "BarbaCuban 90 Miles to Mojo Marinade recall (Prima Foods International, Inc.)", "product": "BarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00096 0", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes: #225/24, #289/24, #347/24, #023/25, #036/25, #128/25, #202/25, #246/25, #323/25.  Best by dates: 02/2026 through 05/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0444-2026%22", "url": "https://recallledger.net/recalls/food-h-0444-2026-barbacuban-90-miles-to-mojo-marinade-net-wt-12-oz-355-ml-12-oz-glas/"}, {"id": "fda-food-h-0443-2026", "source": "FDA", "category": "food", "recall_number": "H-0443-2026", "title": "BarbaCuban 455 Everything Sauce recall (Prima Foods International, Inc.)", "product": "BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Kehe Case Code 1 99284 27227 9", "reason": "Undeclared Quinine", "hazard_level": "Class III", "company": "Prima Foods International, Inc.", "company_location": "Ocala, FL, United States", "date": "2025-12-17", "report_date": "2026-02-11", "status": "Terminated", "distribution": "Distributed in Florida", "states": ["FL"], "nationwide": false, "quantity": "12,214 bottles total", "codes": "Lot Codes: #171/24, #172/24, #190/24, #213/24, #214/24, #218/24, #221/24, #390/24, #331/24, #337/24, #009/25, #051/25, #133/25, #163/25, #170/25, #182/25, #251/25, #282/25.   Best by dates:  12/2025 through 05/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0443-2026%22", "url": "https://recallledger.net/recalls/food-h-0443-2026-barbacuban-455-everything-sauce-original-net-wt-12-oz-355-ml-glas/"}, {"id": "fda-food-h-0441-2026", "source": "FDA", "category": "food", "recall_number": "H-0441-2026", "title": "Lost and Found Energy recall (Fazt & Loud LLC)", "product": "Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged", "reason": "Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.", "hazard_level": "Class III", "company": "Fazt & Loud LLC", "company_location": "Dallas, TX, United States", "date": "2025-12-02", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "N/A", "codes": "LOT #: MO-00911 BB Date: 11/13/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0441-2026%22", "url": "https://recallledger.net/recalls/food-h-0441-2026-lost-and-found-energy-sour-gummy-bear-12pck-16oz-cans-case-upc-850/"}, {"id": "fda-drug-d-0332-2026", "source": "FDA", "category": "drug", "recall_number": "D-0332-2026", "title": "Rheumacare capsules recall (HANDELNINE GLOBAL LLC)", "product": "Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313", "reason": "CGMP Deviations: product found to contain lead.", "hazard_level": "Class I", "company": "HANDELNINE GLOBAL LLC", "company_location": "South Plainfield, NJ, United States", "date": "2025-12-22", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Product was distributed to one customer in NY.", "states": ["NY"], "nationwide": false, "quantity": "4 bottles /30 capsules each", "codes": "Lot: CAM040, Exp. 06/30/2029 Lot: CAL079-N, Exp. 09/30/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0332-2026%22", "url": "https://recallledger.net/recalls/drug-d-0332-2026-rheumacare-capsules-30-count-bottle-mfg-in-india-by-virgo-uap-pharm/"}, {"id": "fda-device-z-1307-2026", "source": "FDA", "category": "device", "recall_number": "Z-1307-2026", "title": "Product Name: Lumipulse ¿-Amyloid Plasma Controls  Model/Catalog Number: 81559 ... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse ¿-Amyloid Plasma Controls  Model/Catalog Number: 81559  Software Version: Not Applicable  Product Description: Lumipulse ¿-Amyloid Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse ¿-Amyloid Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1      Level 1 (2¿ 1.5 mL)  L2      Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "179 units", "codes": "Model/Catalog Number: 81559; UDI-DI: 05414470815593; Lot Number: T8B6116U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1307-2026%22", "url": "https://recallledger.net/recalls/device-z-1307-2026-product-name-lumipulse-amyloid-plasma-controls-model-catalog-numbe/"}, {"id": "fda-device-z-1306-2026", "source": "FDA", "category": "device", "recall_number": "Z-1306-2026", "title": "Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators  Model/Catalog Number:... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators  Model/Catalog Number: 235454  Software Version: Not Applicable  Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators:  The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL.    Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen),  1 ¿ 1.5 mL (4 Concentrations)  CAL 1             0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator  CAL 2          30 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator  CAL 3        100 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator  CAL 4      1000 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator  Contains Tris buffer with protein (bovine) and chemical stabilizers.  Preservative: 0.1% ProClin 950.  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "128 units", "codes": "Model/Catalog Number: 235454; UDI-DI: 04987270235454; Lot Numbers: D8C6022U, D8C6044U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1306-2026%22", "url": "https://recallledger.net/recalls/device-z-1306-2026-product-name-lumipulse-g-amyloid-1-42-n-plasma-calibrators-model-c/"}, {"id": "fda-device-z-1305-2026", "source": "FDA", "category": "device", "recall_number": "Z-1305-2026", "title": "Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges  Model/Catalog Number: 235447  Software Version: Not Applicable  Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC):  Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including  a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System.    Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC):  3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC.  Each IRC contains (abbreviated contents):   1. Antibody-Coated Particle Solution: (Contains anti-¿-amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower,   2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-¿-amyloid 1-42 monoclonal antibodies (mouse) conjugate),   3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer)  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "1423 units", "codes": "Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1305-2026%22", "url": "https://recallledger.net/recalls/device-z-1305-2026-product-name-lumipulse-g-amyloid-1-42-n-plasma-immunoreaction-cartr/"}, {"id": "fda-device-z-1304-2026", "source": "FDA", "category": "device", "recall_number": "Z-1304-2026", "title": "Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558 ... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse pTau 217 Plasma Controls  Model/Catalog Number: 81558  Software Version: Not Applicable  Product Description: Lumipulse pTau 217 Plasma Controls:  This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range.    Lumipulse pTau 217 Plasma Controls: Liquid (Frozen),  2 ¿2 Concentrations  L1     Level 1 (2¿ 1.5 mL)  L2     Level 2 (2¿ 1.5 mL)  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "148 units", "codes": "Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2026%22", "url": "https://recallledger.net/recalls/device-z-1304-2026-product-name-lumipulse-ptau-217-plasma-controls-model-catalog-number/"}, {"id": "fda-device-z-1303-2026", "source": "FDA", "category": "device", "recall_number": "Z-1303-2026", "title": "Product Name: Lumipulse G pTau 217 Plasma Calibrators  Model/Catalog Number: 81557 ... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse G pTau 217 Plasma Calibrators  Model/Catalog Number: 81557  Software Version: Not Applicable  Product Description: Lumipulse G pTau 217 Plasma Calibrators:  The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in  pg/mL.  Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen),  1x1.5 mL (5 Concentrations)  CAL 1             0 pg/mL pTau 217 Plasma Calibrator  CAL 2     0.250 pg/mL pTau 217 Plasma Calibrator  CAL 3     1.000 pg/mL pTau 217 Plasma Calibrator  CAL 4     5.000 pg/mL pTau 217 Plasma Calibrator  CAL 5   10.000 pg/mL pTau 217 Plasma Calibrator  Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative:  0.1% ProClin 300, 0.05% ProClin 950  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "117 units", "codes": "Model/Catalog Number: 81557; UDI-DI: 05414470815579; Lot Numbers: D5C6094U, D5C6125U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2026%22", "url": "https://recallledger.net/recalls/device-z-1303-2026-product-name-lumipulse-g-ptau-217-plasma-calibrators-model-catalog-n/"}, {"id": "fda-device-z-1302-2026", "source": "FDA", "category": "device", "recall_number": "Z-1302-2026", "title": "Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges  Model/Catalog... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges  Model/Catalog Number: 81550  Software Version: Not Applicable  Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC):  Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System.    3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC.  Each IRC contains (abbreviated contents):   1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower,   2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate),   3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer)  Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "1569 units", "codes": "Model/Catalog Number: 81550; UDI-DI: 05414470815500; Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2026%22", "url": "https://recallledger.net/recalls/device-z-1302-2026-product-name-lumipulse-g-ptau-217-plasma-immunoreaction-cartridges-m/"}, {"id": "fda-device-z-1301-2026", "source": "FDA", "category": "device", "recall_number": "Z-1301-2026", "title": "Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number:... recall (Fujirebio Diagnostics, Inc.)", "product": "Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio  Model/Catalog Number: CL0073  Software Version: Not Applicable  Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay.    Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073   is comprised of the following kits, which are imported:  Kit Description, Item#:  Imported from Fujirebio Europe (FRE):  Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550  Lumipulse G pTau 217 Plasma Calibrators set 81557  Lumipulse pTau 217 Plasma Controls 81558  Lumipulse ¿-Amyloid Plasma Controls 81559    Imported from Fujirebio Japan (FRI):  Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447  Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454  Component: No", "reason": "Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).", "hazard_level": "Class II", "company": "Fujirebio Diagnostics, Inc.", "company_location": "Malvern, PA, United States", "date": "2025-12-11", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.", "states": ["AZ", "CA", "FL", "IN", "KS", "KY", "MA", "MD", "MN", "NJ", "PA", "TX", "WA"], "nationwide": true, "quantity": "23 units", "codes": "Model/Catalog Number: CL0073; UDI-DI: 00869164000086; Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio (\"Ratio\") is related to the \"Ratio\" Instructions for Use (IFU). Therefore, each consignee has 1 \"Ratio\" in which they purchase the component kits for.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2026%22", "url": "https://recallledger.net/recalls/device-z-1301-2026-product-name-lumipulse-g-ptau217-b-amyloid-1-42-plasma-ratio-model-c/"}, {"id": "fda-device-z-1298-2026", "source": "FDA", "category": "device", "recall_number": "Z-1298-2026", "title": "Product Name:  Nasal Jejunal Feeding Tube  REF: NJFT-10 recall (Wilson-Cook Medical Inc.)", "product": "Product Name:  Nasal Jejunal Feeding Tube  REF: NJFT-10", "reason": "Nasal feeding tube packaged without the nasal transfer tube component.", "hazard_level": "Class II", "company": "Wilson-Cook Medical Inc.", "company_location": "Winston Salem, NC, United States", "date": "2025-12-15", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "International distribution to the country of Australia.", "states": [], "nationwide": false, "quantity": "60 units", "codes": "Lot Code:W4904253, W4886945, W4880750 UDI: 10827002223018", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1298-2026%22", "url": "https://recallledger.net/recalls/device-z-1298-2026-product-name-nasal-jejunal-feeding-tube-ref-njft-10/"}, {"id": "fda-device-z-1256-2026", "source": "FDA", "category": "device", "recall_number": "Z-1256-2026", "title": "Vortex Surgical Lindsell Sutured IOL Marker recall (Vortex Surgical Inc.)", "product": "Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1256-2026%22", "url": "https://recallledger.net/recalls/device-z-1256-2026-vortex-surgical-lindsell-sutured-iol-marker-vs0390-scleral-marker/"}, {"id": "fda-device-z-1255-2026", "source": "FDA", "category": "device", "recall_number": "Z-1255-2026", "title": "Vortex Surgical  25GA Backflush recall (Vortex Surgical Inc.)", "product": "Vortex Surgical  25GA Backflush, VS0270.25;  25GA Backflush Retractable, VS0275.27", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017;  27GA  Backflush Retractable Pouch UDI 810123480517 Box UDI 810123480791 Lot 2411016", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2026%22", "url": "https://recallledger.net/recalls/device-z-1255-2026-vortex-surgical-25ga-backflush-vs0270-25-25ga-backflush-retractabl/"}, {"id": "fda-device-z-1254-2026", "source": "FDA", "category": "device", "recall_number": "Z-1254-2026", "title": "Vortex Surgical TID Pharos Illuminated Depressor recall (Vortex Surgical Inc.)", "product": "Vortex Surgical TID Pharos Illuminated Depressor, VS0801B", "reason": "XXX", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2026%22", "url": "https://recallledger.net/recalls/device-z-1254-2026-vortex-surgical-tid-pharos-illuminated-depressor-vs0801b/"}, {"id": "fda-device-z-1253-2026", "source": "FDA", "category": "device", "recall_number": "Z-1253-2026", "title": "Rumex Disposable Diamond Dusted ILM Elevator recall (Vortex Surgical Inc.)", "product": "Rumex Disposable Diamond Dusted ILM Elevator, 12-7523", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 5060720920298 Box UDI 5060720920298 Lot 2411033", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2026%22", "url": "https://recallledger.net/recalls/device-z-1253-2026-rumex-disposable-diamond-dusted-ilm-elevator-12-7523/"}, {"id": "fda-device-z-1252-2026", "source": "FDA", "category": "device", "recall_number": "Z-1252-2026", "title": "Vortex Surgical I2 Injection Kit recall (Vortex Surgical Inc.)", "product": "Vortex Surgical I2 Injection Kit, VS0500", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1252-2026%22", "url": "https://recallledger.net/recalls/device-z-1252-2026-vortex-surgical-i2-injection-kit-vs0500/"}, {"id": "fda-device-z-1251-2026", "source": "FDA", "category": "device", "recall_number": "Z-1251-2026", "title": "Tecfen Retractable Membrane Polisher recall (Vortex Surgical Inc.)", "product": "Tecfen Retractable Membrane Polisher, QTPR1267-23", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 817618024508 Box UDI 817618024508 Lot 2411013", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2026%22", "url": "https://recallledger.net/recalls/device-z-1251-2026-tecfen-retractable-membrane-polisher-qtpr1267-23/"}, {"id": "fda-device-z-1250-2026", "source": "FDA", "category": "device", "recall_number": "Z-1250-2026", "title": "Vortex Surgical 25GA I.D.D. Internal Delivery Device recall (Vortex Surgical Inc.)", "product": "Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1250-2026%22", "url": "https://recallledger.net/recalls/device-z-1250-2026-vortex-surgical-25ga-i-d-d-internal-delivery-device-vs0250-25/"}, {"id": "fda-device-z-1249-2026", "source": "FDA", "category": "device", "recall_number": "Z-1249-2026", "title": "Convenience Kits    1. 25GA Convenience Kit - FNX  VS0644.25-FNX    2. 25GA... recall (Vortex Surgical Inc.)", "product": "Convenience Kits    1. 25GA Convenience Kit - FNX  VS0644.25-FNX    2. 25GA Convenience Kit - FXX  VS0644.25-FXX    3.25GA Convenience Kit - XES  VS0644.25-XES", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055  2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028  3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2026%22", "url": "https://recallledger.net/recalls/device-z-1249-2026-convenience-kits-1-25ga-convenience-kit-fnx-vs0644-25-fnx-2/"}, {"id": "fda-device-z-1248-2026", "source": "FDA", "category": "device", "recall_number": "Z-1248-2026", "title": "25GA Subretinal Injection Cannula  VS0220.25 recall (Vortex Surgical Inc.)", "product": "25GA Subretinal Injection Cannula  VS0220.25", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2026%22", "url": "https://recallledger.net/recalls/device-z-1248-2026-25ga-subretinal-injection-cannula-vs0220-25/"}, {"id": "fda-device-z-1247-2026", "source": "FDA", "category": "device", "recall_number": "Z-1247-2026", "title": "Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23   ... recall (Vortex Surgical Inc.)", "product": "Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009  2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051  3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006  4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059  5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011  6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003  7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060  8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054  9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037  10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032  11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039  12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041  13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018  14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040  15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1247-2026%22", "url": "https://recallledger.net/recalls/device-z-1247-2026-vortex-disposable-forceps-and-cannula-1-23ga-actu8-forceps-adaptiv/"}, {"id": "fda-device-z-1246-2026", "source": "FDA", "category": "device", "recall_number": "Z-1246-2026", "title": "Oertli  1. 23G Laser Probe OS4 Flex-Tip  VK401113    2. 23G Laser Probe OS4... recall (Vortex Surgical Inc.)", "product": "Oertli  1. 23G Laser Probe OS4 Flex-Tip  VK401113    2. 23G Laser Probe OS4 Illuminated Flex-Tip  VK401213    3. 23G Laser Probe OS4 Intuitive Exendable  VK401323    4. 25G Laser Probe OS4 Flex-Tip  VK401115    5. 25G Laser Probe OS4 Illuminated Flex-Tip  VK401215    6. 25G Laser Probe OS4 Intuitive Exendable  VK401325    7. 27G Laser Probe OS4 Intuitive Exendable  VK401327", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031  2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034  3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033  4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022;  5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035  6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025  7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1246-2026%22", "url": "https://recallledger.net/recalls/device-z-1246-2026-oertli-1-23g-laser-probe-os4-flex-tip-vk401113-2-23g-laser-prob/"}, {"id": "fda-device-z-1245-2026", "source": "FDA", "category": "device", "recall_number": "Z-1245-2026", "title": "Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser... recall (Vortex Surgical Inc.)", "product": "Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "1. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027  2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026  3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031  4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025  5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023  6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2026%22", "url": "https://recallledger.net/recalls/device-z-1245-2026-vortex-surgical-1-23ga-laser-probe-curved-cat-no-vs0120-23-2/"}, {"id": "fda-device-z-1244-2026", "source": "FDA", "category": "device", "recall_number": "Z-1244-2026", "title": "Volk Single Use Vitrectomy Lenses    1. Flat Vitrectomy Lens recall (Vortex Surgical Inc.)", "product": "Volk Single Use Vitrectomy Lenses    1. Flat Vitrectomy Lens, Catalog VFD  2. Volk Magnifying Lens, Catalog VMD", "reason": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.", "hazard_level": "Class II", "company": "Vortex Surgical Inc.", "company_location": "Saint Charles, MO, United States", "date": "2025-12-16", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.", "states": ["AL", "AR", "AZ", "CA", "CT", "FL", "HI", "IA", "IL", "IN", "KY", "MA", "MI", "MN", "MS", "NC", "NE", "NJ", "NM", "NY", "OH", "OR", "PA", "PR", "RI", "SC", "SD", "TN", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "14,789 (8651 US; 6138 OUS)", "codes": "1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020  2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2026%22", "url": "https://recallledger.net/recalls/device-z-1244-2026-volk-single-use-vitrectomy-lenses-1-flat-vitrectomy-lens-catalog/"}, {"id": "fda-device-z-1243-2026", "source": "FDA", "category": "device", "recall_number": "Z-1243-2026", "title": "Focalyx Fusion recall (Focalyx Technologies, LLC.)", "product": "Focalyx Fusion", "reason": "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.", "hazard_level": "Class II", "company": "Focalyx Technologies, LLC.", "company_location": "Hialeah, FL, United States", "date": "2025-12-23", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of NY, MA, FL and the countries of ES, VE, DO.", "states": ["FL", "MA", "NY"], "nationwide": true, "quantity": "18", "codes": "UDI-DI: 00860003552001. Software Versions: 1.3, 1.5, 1.6. Serial Numbers: IF-FF-B-1-22080504, IF-FF-B-1-TPAA998118, IF-FF-B-1-351238, IF-FF-B-1-TPAB081335, IF-FF-B-1-22080508, IF-FF-B-1-TPAB200331, IF-FF-B-1-TPAB200333, IF-FF-B-1-TPAC505383, IF-FF-B-1-TPAB200348, IF-FF-B-1-TPAB540364, IF-FF-B-1-S5ARQL009253NYZ, IF-FF-B-1-SCARQL0014096YZ, IF-FF-B-1-TPAB532163, IF-FF-B-1-SCARQL00136033KK, IF-FF-B-1-TPAB540359, IF-FF-B-1-TPAB081326, IF-FF-B-1-22080505, IF-FF-B-1-TPAB081324", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1243-2026%22", "url": "https://recallledger.net/recalls/device-z-1243-2026-focalyx-fusion/"}, {"id": "fda-device-z-1242-2026", "source": "FDA", "category": "device", "recall_number": "Z-1242-2026", "title": "NAEOTOM Alpha.Pro  Software applications:   syngo.CT Brain Quantification  syngo.CT... recall (Siemens Medical Solutions USA, Inc)", "product": "NAEOTOM Alpha.Pro  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel Hyperdensities  syngo.CT ASPECTS", "reason": "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.", "hazard_level": "Class II", "company": "Siemens Medical Solutions USA, Inc", "company_location": "Malvern, PA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.", "states": [], "nationwide": true, "quantity": "2 units", "codes": "Material Number: 10191100; UDI-DI: 04068151014655; Serial Numbers: 258043, 258055;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1242-2026%22", "url": "https://recallledger.net/recalls/device-z-1242-2026-naeotom-alpha-pro-software-applications-syngo-ct-brain-quantificat/"}, {"id": "fda-device-z-1241-2026", "source": "FDA", "category": "device", "recall_number": "Z-1241-2026", "title": "NAEOTOM Alpha.Prime  Software applications:   syngo.CT Brain Quantification  syngo.CT... recall (Siemens Medical Solutions USA, Inc)", "product": "NAEOTOM Alpha.Prime  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel Hyperdensities  syngo.CT ASPECTS", "reason": "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.", "hazard_level": "Class II", "company": "Siemens Medical Solutions USA, Inc", "company_location": "Malvern, PA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.", "states": [], "nationwide": true, "quantity": "5 units", "codes": "Material Number: 11549431; UDI-DI: 04056869978741; Serial Numbers: 183047, 183051, 183048, 183050, 183046;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1241-2026%22", "url": "https://recallledger.net/recalls/device-z-1241-2026-naeotom-alpha-prime-software-applications-syngo-ct-brain-quantific/"}, {"id": "fda-device-z-1240-2026", "source": "FDA", "category": "device", "recall_number": "Z-1240-2026", "title": "NAEOTOM Alpha  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel... recall (Siemens Medical Solutions USA, Inc)", "product": "NAEOTOM Alpha  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel Hyperdensities  syngo.CT ASPECTS", "reason": "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.", "hazard_level": "Class II", "company": "Siemens Medical Solutions USA, Inc", "company_location": "Malvern, PA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.", "states": [], "nationwide": true, "quantity": "88 units", "codes": "Material Number: 11330003; UDI-DI: 04056869263168; Serial Numbers: 127226, 127156, 127268, 127260, 127217, 127313, 127272, 127275, 127276, 127206, 127118, 127152, 127091, 127183, 127166, 127125, 127264, 127220, 127104, 127037, 127136, 127201, 127137, 127221, 127205, 127176, 127297, 127245, 127138, 127314, 127310, 127195, 127259, 127093, 127085, 127215, 127235, 127208, 127256, 127036, 127180, 127242, 127115, 127290, 127146, 127039, 127315, 127203, 127071, 127170, 127318, 127273, 127101, 127046, 127133, 127246, 127083, 127240, 127241, 127299, 127068, 127224, 127139, 127251, 127119, 127265, 127311, 127185, 127111, 127112, 127102, 127249, 127266, 127280, 127132, 127227, 127277, 258044, 127142, 127289, 127075, 127144, 127130, 127131, 127080, 127124, 127271, 127169;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1240-2026%22", "url": "https://recallledger.net/recalls/device-z-1240-2026-naeotom-alpha-software-applications-syngo-ct-brain-quantification/"}, {"id": "fda-device-z-1239-2026", "source": "FDA", "category": "device", "recall_number": "Z-1239-2026", "title": "SOMATOM X.ceed  Software applications:   syngo.CT Brain Quantification  syngo.CT... recall (Siemens Medical Solutions USA, Inc)", "product": "SOMATOM X.ceed  Software applications:   syngo.CT Brain Quantification  syngo.CT Vessel Hyperdensities  syngo.CT ASPECTS", "reason": "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.", "hazard_level": "Class II", "company": "Siemens Medical Solutions USA, Inc", "company_location": "Malvern, PA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.", "states": [], "nationwide": true, "quantity": "2 units", "codes": "Material Number: 11330002; UDI-DI: 04056869231051; Serial Numbers: 125205, 125250;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1239-2026%22", "url": "https://recallledger.net/recalls/device-z-1239-2026-somatom-x-ceed-software-applications-syngo-ct-brain-quantification/"}, {"id": "fda-device-z-1237-2026", "source": "FDA", "category": "device", "recall_number": "Z-1237-2026", "title": "TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE recall (Tornier, Inc)", "product": "TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318", "reason": "A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.", "hazard_level": "Class II", "company": "Tornier, Inc", "company_location": "Bloomington, MN, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "427", "codes": "Lot AZ4824290", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1237-2026%22", "url": "https://recallledger.net/recalls/device-z-1237-2026-tornier-perform-reversed-perip-screw-5-0mmx18mm-non-sterile-catalog-n/"}, {"id": "fda-device-z-1235-2026", "source": "FDA", "category": "device", "recall_number": "Z-1235-2026", "title": "CellMek SPS Sample Preparation System recall (Beckman Coulter, Inc.)", "product": "CellMek SPS Sample Preparation System, REF: C44603, with software", "reason": "Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.", "hazard_level": "Class II", "company": "Beckman Coulter, Inc.", "company_location": "Miami, FL, United States", "date": "2025-12-23", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL, OR, IL and the countries of AB, BE, ES, FR, NL, ON, DE, AT, VIC, AU, GB, SK, MX, CH.", "states": ["AL", "IL", "MA", "MO", "OR", "WA"], "nationwide": true, "quantity": "50", "codes": "UDI-DI: 15099590750312. Software Version 2.3.90.0", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2026%22", "url": "https://recallledger.net/recalls/device-z-1235-2026-cellmek-sps-sample-preparation-system-ref-c44603-with-software/"}, {"id": "fda-device-z-1163-2026", "source": "FDA", "category": "device", "recall_number": "Z-1163-2026", "title": "*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm recall (Boston Scientific Corporation)", "product": "*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Material Number (UPN): M00553560;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "588 units", "codes": "Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 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37660774, 37660775, 37660777, 37660778, 37665497, 37667998, 37672121, 37675664, 37675665, 37689944, 37689945, 37696688, 37720785, 37723579, 37731195, 37731196, 37731197, 37742018, 37745174, 37746915, 37750340, 37750341, 37754384, 37754385, 37755928, 37755939, 37771352, 37771353, 37771354, 37771355, 37777208, 37778063, 37780175, 37780176, 37809876, 37809877, 37809878, 37809879, 37811060, 37811061, 37811062, 37811063, 37817124, 37817482, 37817483, 37820575, 37820576, 37820577, 37837386, 37837890, 37837891, 37844022, 37846410, 37846411, 37846412;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1163-2026%22", "url": "https://recallledger.net/recalls/device-z-1163-2026-hot-axios-stent-and-electrocautery-enhanced-delivery-system-20mm-x/"}, {"id": "fda-device-z-1162-2026", "source": "FDA", "category": "device", "recall_number": "Z-1162-2026", "title": "*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   8mm x 8mm recall (Boston Scientific Corporation)", "product": "*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   8mm x 8mm;  Material Number (UPN): M00553530;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "150 units", "codes": "Material Number (UPN): M00553530; UDI-DI: 8714729904557; Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423, 36190575, 36191222, 36194448, 36218745, 36227778, 36227779, 36241500, 36271259, 36280398, 36293880, 36300839, 36301620, 36343103, 36343104, 36364646, 36425887, 36469811, 36471228, 36491879, 36492660, 36506029, 36510220, 36510221, 36513401, 36513402, 36513403, 36517139, 36517220, 36525208, 36525209, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792, 36853596, 36865505, 36873631, 36873632, 36873906, 36874863, 36904228, 36904229, 36904230, 36907002, 36907003, 36907004, 36907028, 37102533, 37102534, 37102535, 37102536, 37102537, 37459567, 37459568, 37459569, 37459570, 37463133, 37470670, 37498192, 37511243, 37519095, 37519096, 37844029, 37519097, 37520927, 37530320, 37530321, 37530333, 37533308, 37541933, 37571927, 37571928, 37579364, 37579366, 37579367, 37580630, 37585525, 37585526, 37589261, 37589262, 37594668, 37649481, 37649482, 37649483, 37650631, 37694052, 37699011, 37699012, 37708202, 37779125, 37779126, 37780822, 37780823, 37780824, 37823589, 37823590, 37827568, 37827569, 37833165, 37833176, 37834499;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2026%22", "url": "https://recallledger.net/recalls/device-z-1162-2026-hot-axios-stent-and-electrocautery-enhanced-delivery-system-8mm-x-8/"}, {"id": "fda-device-z-1161-2026", "source": "FDA", "category": "device", "recall_number": "Z-1161-2026", "title": "HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   6mm x 8mm recall (Boston Scientific Corporation)", "product": "HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   6mm x 8mm;  Material Number (UPN): M00553520;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "266 units", "codes": "Material Number (UPN): M00553520; UDI-DI: 8714729904540; Lot Numbers: 36067957, 36067958, 36067959, 36067960, 36067961, 36099410, 36102139, 36111317, 36111318, 36111319, 36132439, 36132800, 36136724, 36136725, 36144054, 36154527, 36154528, 36154529, 36156019, 36164532, 36164990, 36176206, 36176207, 36177448, 36191239, 36199389, 36199390, 36217761, 36241713, 36251361, 36252913, 36271441, 36271442, 36281910, 36281911, 36292639, 36292680, 36292681, 36293836, 36300838, 36317858, 36317859, 36318240, 36323786, 36323787, 36331036, 36331037, 36331038, 36331039, 36397921, 36397922, 36397923, 36421238, 36424644, 36424645, 36427248, 36446498, 36447200, 36447201, 36449569, 36449570, 36449571, 36458829, 36459567, 36459568, 36459569, 36459570, 36461959, 36462320, 36468392, 36468393, 36468394, 36502795, 36506161, 36506163, 36509326, 36520053, 36523274, 36528114, 36536932, 36536933, 36548030, 36548031, 36548850, 36548851, 36552680, 36559035, 36559036, 36567446, 36567447, 36567448, 36574150, 36581585, 36581586, 36582790, 36582791, 36585188, 36585189, 36591087, 36592499, 36592660, 36596040, 36596041, 36609818, 36609819, 36610400, 36610401, 36621583, 36621584, 36634546, 36634547, 36664793, 36673195, 36673557, 36673558, 36675688, 36675689, 36675690, 36675692, 36677844, 36677845, 36677846, 36680231, 36680232, 36683260, 36683261, 36683262, 36693971, 36693972, 36717713, 36717714, 36717715, 36717819, 36721863, 36731805, 36731806, 36738965, 36738966, 36743835, 36750922, 36750924, 36753179, 36753400, 36781577, 36781578, 36781579, 36784378, 36784379, 36788332, 36788333, 36788334, 36792650, 36799316, 36832750, 36832837, 36832838, 36833682, 36834573, 36843542, 36844231, 36846161, 36846163, 36864951, 36864952, 36865501, 36865502, 36865504, 36865553, 36868065, 36872344, 36872346, 36878419, 36884609, 36884612, 36884613, 36895367, 36895368, 36896664, 36907033, 36907249, 36907378, 36907400, 36914565, 36915206, 36915207, 36916329, 36916330, 36917403, 36917404, 36917993, 37000847, 37003365, 37423232, 37423233, 37427258, 37427259, 37427360, 37427361, 37427362, 37437936, 37438283, 37438286, 37438287, 37439978, 37440320, 37451304, 37456594, 37457216, 37457217, 37457269, 37459571, 37463623, 37463624, 37463625, 37463628, 37469756, 37469757, 37469758, 37470669, 37472148, 37475121, 37475122, 37481983, 37486079, 37518915, 37518916, 37518917, 37519094, 37532420, 37532421, 37533309, 37543372, 37558499, 37558542, 37567252, 37567253, 37567400, 37568848, 37568849, 37571930, 37685005, 37686597, 37689957, 37689958, 37698144, 37704842, 37761033, 37761034, 37775246, 37776579, 37776720, 37776721, 37780826, 37785688, 37785689, 37811064, 37817121, 37823587, 37823588, 37826529, 37826530, 37827570, 37834839, 37836866, 37836867, 37842827;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1161-2026%22", "url": "https://recallledger.net/recalls/device-z-1161-2026-hot-axios-stent-and-electrocautery-enhanced-delivery-system-6mm-x-8m/"}, {"id": "fda-device-z-1160-2026", "source": "FDA", "category": "device", "recall_number": "Z-1160-2026", "title": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall (Boston Scientific Corporation)", "product": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;  Material Number (UPN): M00553690;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "59 units", "codes": "Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043,", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1160-2026%22", "url": "https://recallledger.net/recalls/device-z-1160-2026-axios-stent-and-electrocautery-enhanced-delivery-system-8mm-x-8mm/"}, {"id": "fda-device-z-1159-2026", "source": "FDA", "category": "device", "recall_number": "Z-1159-2026", "title": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall (Boston Scientific Corporation)", "product": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;  Material Number (UPN): M00553680;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "39 units", "codes": "Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653, 36167912, 36241714, 36401105, 36408034, 36421237, 36447549, 36447550, 36520894, 36530482, 36530483, 36530484, 36533326, 36536257, 36536258, 36570788, 36570789, 36578110, 36581584, 36603297, 36611362, 37014108, 37429734, 37429735, 37433804, 37433805, 37440329, 37451303, 37456593, 37495326, 37511241, 37519092, 37519093, 37780825;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1159-2026%22", "url": "https://recallledger.net/recalls/device-z-1159-2026-axios-stent-and-electrocautery-enhanced-delivery-system-6mm-x-8mm/"}, {"id": "fda-device-z-1158-2026", "source": "FDA", "category": "device", "recall_number": "Z-1158-2026", "title": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall (Boston Scientific Corporation)", "product": "AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;  Material Number (UPN): M00553660;", "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "hazard_level": "Class I", "company": "Boston Scientific Corporation", "company_location": "Marlborough, MA, United States", "date": "2025-12-19", "report_date": "2026-02-11", "status": "Ongoing", "distribution": "Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.", "states": ["PR"], "nationwide": true, "quantity": "557 units", "codes": "Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006, , 35961007, , 35962524, , 35967379, , 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36280395, 36280396, 36280397, 36281912, 36281913, 36281914, 36283860, 36292682, 36292683, 36292684, 36292689, 36292690, 36292691, 36294495, 36301621, 36301622, 36301623, 36301624, 36302290, 36302291, 36302292, 36319024, 36319025, 36319026, 36320016, 36320017, 36323789, 36323790, 36324720, 36325159, 36325560, 36325568, 36325569, 36332101, 36332102, 36341577, 36342114, 36342418, 36352008, 36352009, 36355049, 36355050, 36355752, 36359567, 36362263, 36362264, 36362265, 36363150, , 36363151, , 36364647, , 36372361, , 36372362, 36377757, 36378548, 36380549, 36388531, 36390612, 36396985, 36399492, 36403441, 36408983, 36408984, 36417820, 36417821, 36418721, 36418722, 36424650, 36424651, 36424652, 36425889, 36425890, 36425891, 36425892, 36462323, 36462324, 36469427, 36469428, 36469812, 36472250, 36472253, 36472254, 36475370, 36478478, 36478479, 36572740, 36572741, 36573582, 36573583, 36573587, 36573588, 36573589, 36573590, 36591073, 36591074, 36591075, 36603384, 36603385, 36603386, 36604188, 36604189, 36604190, 36604191, 36604748, 36604749, 36607249, 36607250, 36607251, 36607252, 36607253, 36610818, 36610819, 36611060, 36615703, 36615704, 36621589, 36621590, 36623324, 36623325, 36623326, 36693849, 36693850, 36693851, 36693852, 36694699, 36695020, 36695021, 36695023, 36698247, 36698249, 36698251, 36698527, 36698528, 36698529, 36698530, 36698531, 36698532, 36706712, 36706713, 36706714, 36706715, 36709766, 36709767, 36709768, 36709769, 36713255, 36713256, 36713257, 36713258, 36717717, 36717718, 36717719, 36717800, 36717801, 36717802, 36718966, 36718967, 36723909, 36723910, 36728154, 36764237, 36764238, 36767449, 36767450, 36771884, 36771885, 36771886, 36785593, 36788793, 36788794, 36788795, 36795369, 36795370, 36796430, 36796431, 36804013, 36804375, 36839665, 36895362, 36895363, 36895364, 36958216, 36958217, 36962750, 36970218, 36970219, 36980309, 36980310, , 36981855, , 36981856, , 36982694, , 36983909, 36985933, 36988630, 36988631, 36988632, 36990382, 36990383, 36991168, 36991170, 36991683, 36992721, 37014102, 37014103, 37014104, 37027339, 37028180, 37028181, 37030756, 37032104, 37036344, 37036345, 37037505, 37037506, 37040169, 37041012, 37041435, 37041436, 37046449, 37046450, 37046928, 37046929, 37048665, 37049464, 37049465, 37049874, 37050321, 37050322, 37050323, 37055465, 37055466, 37055467, 37056013, 37056014, 37057032, 37059006, 37059010, 37094844, 37106164, 37106583, 37131143, 37131144, 37131145, 37131146, 37177253, 37177271, 37177272, 37179955, 37179956, 37180902, 37180903, 37182323, 37183490, 37188257, 37188258, 37197563, 37197578, 37198908, 37199019, 37199360, 37199361, 37199972, 37199973, 37209169, 37209170, 37209171, 37211282, 37211285, 37212243, 37212244, 37212245, 37212246, 37213246, 37213247, 37213248, 37213249, 37240012, 37240013, 37240236, 37240237, 37240249, 37240250, 37240252, 37240254, 37242247, 37242248, 37242249, 37243754, 37243755, 37243756, 37247304, 37247305, 37247306, 37283604, 37283605, 37291851, 37291852, 37292951, 37292952, 37296017, 37296018, 37296019, 37297941, 37300544, 37300545, 37300546, 37302814, 37308038, 37308039, 37325355, 37328835, 37328836, 37328838, 37331112, 37332012, 37333358, 37333362, 37337364, 37340128, 37340129, 37340130, 37340131, 37340270, 37340271, 37341078, 37341079, 37344296, , 37344297, , 37346443, , 37346445, , 37348330, 37348331, 37352140, 37352141, 37354943, 37354944, 37357958, 37357959, 37358120, 37359884, 37359885, 37365502, 37365503, 37365504, 37365505, 37375861, 37388591, 37388592, 37388593, 37400608, 37402464, 37402466, 37410374, 37411886, 37411887, 37415923, 37415924, 37415925, 37427250, 37429329, 37429330, 37438134, 37438135, 37439609, 37439610, 37439611, 37451308, 37451309, 37454250, 37454251, 37456595, 37456596, 37459573, 37567407, 37573089, 37573090, 37573091, 37575640, 37578876, 37578877, 37578879, 37579368, 37579369, 37579370, 37582027, 37585524, 37588798, 37588799, 37589260, 37592382, 37592383, 37592384, 37596205, 37596206, 37596207, 37596208, 37601263, 37602176, 37602177, 37602178, 37602179, 37603348, 37607457, 37607458, 37607459, 37607540, 37625485, 37625486, 37626455, 37626456, 37631100, 37631101, 37633190, 37633191, 37638120, 37638121, 37638122, 37639137, 37639138, 37644407, 37644408, 37644409, 37649491, 37649492, 37686664, 37686665, 37686666, 37700937, 37700938, 37706532, 37706533, 37706534, 37708203, 37708204, 37716332, 37716333, 37718549, 37720553, 37720554, 37720555, 37727831, 37730055, 37754383, 37758168, 37758169, 37758170, 37759554, 37761362, 37761363, 37785682, 37785683, 37787089, 37787090, 37789164, 37789168, 37789169, 37820578, 37823439, 37826531, 37826532, 37832473, 37832474, 37833962, 37833963, 37834751, 37844023;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1158-2026%22", "url": "https://recallledger.net/recalls/device-z-1158-2026-axios-stent-and-electrocautery-enhanced-delivery-system-20mm-x-10mm/"}, {"id": "fda-food-h-0439-2026", "source": "FDA", "category": "food", "recall_number": "H-0439-2026", "title": "Goldenroot Yuzu Ginger Lemongrass Ginger Beer.  12 oz. recall (Weaver's Brew LLC)", "product": "Goldenroot Yuzu Ginger Lemongrass Ginger Beer.  12 oz. (355 ml)  UPC 8 50052-32817 7.  Keep Cold.  Manufactured By Goldenroot, 3841 Market St #113, Denton, TX  76209.", "reason": "Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.", "hazard_level": "Class II", "company": "Weaver's Brew LLC", "company_location": "Denton, TX, United States", "date": "2025-12-08", "report_date": "2026-02-04", "status": "Terminated", "distribution": "Texas and California", "states": ["CA", "TX"], "nationwide": false, "quantity": "649 cases", "codes": "All Use By Dates up to 6/14/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0439-2026%22", "url": "https://recallledger.net/recalls/food-h-0439-2026-goldenroot-yuzu-ginger-lemongrass-ginger-beer-12-oz-355-ml-upc-8/"}, {"id": "fda-food-h-0438-2026", "source": "FDA", "category": "food", "recall_number": "H-0438-2026", "title": "Goldenroot Lemon Ginger Jalapeno Ginger Beer.  12 oz. recall (Weaver's Brew LLC)", "product": "Goldenroot Lemon Ginger Jalapeno Ginger Beer.  12 oz. (355 ml)  UPC 8 50052-32820 7.  Keep Cold.  Manufactured By Goldenroot, 3841 Market St #113, Denton, TX  76209.", "reason": "Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.", "hazard_level": "Class II", "company": "Weaver's Brew LLC", "company_location": "Denton, TX, United States", "date": "2025-12-08", "report_date": "2026-02-04", "status": "Terminated", "distribution": "Texas and California", "states": ["CA", "TX"], "nationwide": false, "quantity": "421 cases", "codes": "All Use By Dates up to 6/14/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0438-2026%22", "url": "https://recallledger.net/recalls/food-h-0438-2026-goldenroot-lemon-ginger-jalapeno-ginger-beer-12-oz-355-ml-upc-8/"}, {"id": "fda-food-h-0437-2026", "source": "FDA", "category": "food", "recall_number": "H-0437-2026", "title": "Goldenroot Lemon Ginger Hibiscus Ginger Beer.  12 oz. recall (Weaver's Brew LLC)", "product": "Goldenroot Lemon Ginger Hibiscus Ginger Beer.  12 oz. (355 ml)  UPC 8 50052-32821 4.  Keep Cold.  Manufactured By Goldenroot, 3841 Market St #113, Denton, TX  76209.", "reason": "Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.", "hazard_level": "Class II", "company": "Weaver's Brew LLC", "company_location": "Denton, TX, United States", "date": "2025-12-08", "report_date": "2026-02-04", "status": "Terminated", "distribution": "Texas and California", "states": ["CA", "TX"], "nationwide": false, "quantity": "1014 cases", "codes": "All Use By Dates up to 6/14/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0437-2026%22", "url": "https://recallledger.net/recalls/food-h-0437-2026-goldenroot-lemon-ginger-hibiscus-ginger-beer-12-oz-355-ml-upc-8/"}, {"id": "fda-food-h-0436-2026", "source": "FDA", "category": "food", "recall_number": "H-0436-2026", "title": "Goldenroot Lemon Double Ginger recall (Weaver's Brew LLC)", "product": "Goldenroot Lemon Double Ginger, Ginger Beer.  12 oz. (355 ml)  UPC 8 50052-32819 1.  Keep Cold.  Manufactured By Goldenroot, 3841 Market St #113, Denton, TX  76209.", "reason": "Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.", "hazard_level": "Class II", "company": "Weaver's Brew LLC", "company_location": "Denton, TX, United States", "date": "2025-12-08", "report_date": "2026-02-04", "status": "Terminated", "distribution": "Texas and California", "states": ["CA", "TX"], "nationwide": false, "quantity": "1070 cases", "codes": "All Use By Dates up to 6/14/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0436-2026%22", "url": "https://recallledger.net/recalls/food-h-0436-2026-goldenroot-lemon-double-ginger-ginger-beer-12-oz-355-ml-upc-8-5/"}, {"id": "fda-food-h-0435-2026", "source": "FDA", "category": "food", "recall_number": "H-0435-2026", "title": "Goldenroot Lemon Ginger Elderberry Ginger Beer.  12 oz. recall (Weaver's Brew LLC)", "product": "Goldenroot Lemon Ginger Elderberry Ginger Beer.  12 oz. (355 ml)  UPC 8 50052-32818 4.  Keep Cold.  Manufactured By Goldenroot, 3841 Market St #113, Denton, TX  76209.", "reason": "Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.", "hazard_level": "Class II", "company": "Weaver's Brew LLC", "company_location": "Denton, TX, United States", "date": "2025-12-08", "report_date": "2026-02-04", "status": "Terminated", "distribution": "Texas and California", "states": ["CA", "TX"], "nationwide": false, "quantity": "1066 cases", "codes": "All Use By Dates up to 6/14/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0435-2026%22", "url": "https://recallledger.net/recalls/food-h-0435-2026-goldenroot-lemon-ginger-elderberry-ginger-beer-12-oz-355-ml-upc/"}, {"id": "fda-food-h-0432-2026", "source": "FDA", "category": "food", "recall_number": "H-0432-2026", "title": "Roasted Green Chile & Jack Cheese Tamales  Ingredients: Organic Corn Flour Masa recall (Prima Vera Nueva, Inc.)", "product": "Roasted Green Chile & Jack Cheese Tamales  Ingredients: Organic Corn Flour Masa, Roasted Green Chiles, Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt, Enzymes), Non-GMO Corn, Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate), Water, Citric Acid.  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000034", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "31,672 packages (4 tamales/package)", "codes": "UPC: 748732000034", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0432-2026%22", "url": "https://recallledger.net/recalls/food-h-0432-2026-roasted-green-chile-jack-cheese-tamales-ingredients-organic-corn-f/"}, {"id": "fda-food-h-0431-2026", "source": "FDA", "category": "food", "recall_number": "H-0431-2026", "title": "Black Bean Bonanza Tamales with Black Beans and Jack Cheese  Ingredients: Organic Corn... recall (Prima Vera Nueva, Inc.)", "product": "Black Bean Bonanza Tamales with Black Beans and Jack Cheese  Ingredients: Organic Corn Flour Masa, Black Beans, Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt, Enzymes), Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Butter, Non-GMO Corn, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000218", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "26,457 packages (4 tamales/package)", "codes": "UPC: 748732000218", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0431-2026%22", "url": "https://recallledger.net/recalls/food-h-0431-2026-black-bean-bonanza-tamales-with-black-beans-and-jack-cheese-ingredien/"}, {"id": "fda-food-h-0430-2026", "source": "FDA", "category": "food", "recall_number": "H-0430-2026", "title": "Butternut Squash Tamales with Roasted Green Chiles recall (Prima Vera Nueva, Inc.)", "product": "Butternut Squash Tamales with Roasted Green Chiles, NO DAIRY  Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, Roasted Green Chiles, Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000300", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "18,876 packages (4 tamales/package)", "codes": "UPC: 748732000300", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0430-2026%22", "url": "https://recallledger.net/recalls/food-h-0430-2026-butternut-squash-tamales-with-roasted-green-chiles-no-dairy-ingredie/"}, {"id": "fda-food-h-0429-2026", "source": "FDA", "category": "food", "recall_number": "H-0429-2026", "title": "Roasted Green Chile Tamales NO DAIRY  Ingredients: Organic Corn Flour Masa recall (Prima Vera Nueva, Inc.)", "product": "Roasted Green Chile Tamales NO DAIRY  Ingredients: Organic Corn Flour Masa, Roasted Green Chiles, Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate), Water, Citric Acid.  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000270", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "21,705 packages (4 tamales/package)", "codes": "UPC: 748732000270", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0429-2026%22", "url": "https://recallledger.net/recalls/food-h-0429-2026-roasted-green-chile-tamales-no-dairy-ingredients-organic-corn-flour/"}, {"id": "fda-food-h-0428-2026", "source": "FDA", "category": "food", "recall_number": "H-0428-2026", "title": "Black Bean Bonanza Tamales with Black Beans NO DAIRY  Ingredients: Organic Corn Flour Masa recall (Prima Vera Nueva, Inc.)", "product": "Black Bean Bonanza Tamales with Black Beans NO DAIRY  Ingredients: Organic Corn Flour Masa, Black Beans, Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000287", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "16,790 packages (4 tamales/package)", "codes": "UPC: 748732000287", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0428-2026%22", "url": "https://recallledger.net/recalls/food-h-0428-2026-black-bean-bonanza-tamales-with-black-beans-no-dairy-ingredients-org/"}, {"id": "fda-food-h-0427-2026", "source": "FDA", "category": "food", "recall_number": "H-0427-2026", "title": "BBQ Chipotle Bean & White Cheddar Tamales  Ingredients: Organic Corn Flour Masa recall (Prima Vera Nueva, Inc.)", "product": "BBQ Chipotle Bean & White Cheddar Tamales  Ingredients: Organic Corn Flour Masa, Beans, Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Butter, Non-GMO Corn, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000256", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "27,964 packages (4 tamales/package)", "codes": "UPC: 748732000256", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0427-2026%22", "url": "https://recallledger.net/recalls/food-h-0427-2026-bbq-chipotle-bean-white-cheddar-tamales-ingredients-organic-corn-f/"}, {"id": "fda-food-h-0426-2026", "source": "FDA", "category": "food", "recall_number": "H-0426-2026", "title": "Mushroom recall (Prima Vera Nueva, Inc.)", "product": "Mushroom, Spinach & Salsa Tamales No Dairy  Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Tomatoes, Onions, Jalapenos, Non-hydrogenated Vegetable Shortning, Salt, Spices, Baking Powder.  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000317", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "16,264 packages (4 tamales/package)", "codes": "UPC: 748732000317", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0426-2026%22", "url": "https://recallledger.net/recalls/food-h-0426-2026-mushroom-spinach-salsa-tamales-no-dairy-ingredients-organic-corn/"}, {"id": "fda-food-h-0425-2026", "source": "FDA", "category": "food", "recall_number": "H-0425-2026", "title": "Roasted Pumpkin & White Cheddar Tamales  Ingredients: Organic Corn Flour Masa recall (Prima Vera Nueva, Inc.)", "product": "Roasted Pumpkin & White Cheddar Tamales  Ingredients: Organic Corn Flour Masa, Pumpkin, Green Chile, Sharp Cheddar Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Contains Milk  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000263", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "9,656 packages (4 tamales/package)", "codes": "UPC: 748732000263", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0425-2026%22", "url": "https://recallledger.net/recalls/food-h-0425-2026-roasted-pumpkin-white-cheddar-tamales-ingredients-organic-corn-flo/"}, {"id": "fda-food-h-0424-2026", "source": "FDA", "category": "food", "recall_number": "H-0424-2026", "title": "Mushroom recall (Prima Vera Nueva, Inc.)", "product": "Mushroom, Spinach & Salsa Tamales with 2 Cheeses  Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Onions, Jalapenos, Jack and White Cheddar Cheese (pasteurized milk, cheese cultures, salt and enzymes), Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000249", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "25,889 packages (4 tamales/package)", "codes": "UPC: 748732000249", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0424-2026%22", "url": "https://recallledger.net/recalls/food-h-0424-2026-mushroom-spinach-salsa-tamales-with-2-cheeses-ingredients-organic/"}, {"id": "fda-food-h-0423-2026", "source": "FDA", "category": "food", "recall_number": "H-0423-2026", "title": "Butternut Squash Tamales With Roasted Green Chiles recall (Prima Vera Nueva, Inc.)", "product": "Butternut Squash Tamales With Roasted Green Chiles, Corn & Jack Cheese  Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, Organic Roasted Green Chiles, Non-GMO Corn, Organic Jalapeno Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Organic Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate).  Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes.  Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz.  UPC: 748732000232", "reason": "Potential contamination with biological hazards (Listeria monocytogenes).", "hazard_level": "Class II", "company": "Prima Vera Nueva, Inc.", "company_location": "Sonoma, CA, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Terminated", "distribution": "U.S. Distribution: CA, NV", "states": ["CA", "NV"], "nationwide": false, "quantity": "30,327 packages (4 tamales/package)", "codes": "UPC: 748732000232", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0423-2026%22", "url": "https://recallledger.net/recalls/food-h-0423-2026-butternut-squash-tamales-with-roasted-green-chiles-corn-jack-cheese/"}, {"id": "fda-food-h-0421-2026", "source": "FDA", "category": "food", "recall_number": "H-0421-2026", "title": "HIGHER HARVEST by H-E-B brand recall (Plant Based Innovations, LLC)", "product": "HIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM, LEMON JUICE CONCENTRATE, LIVE AND ACTIVE CULTURES, VITAMIN B12; CONTAINS: COCONUT", "reason": "Contains undeclared Almonds", "hazard_level": "Class II", "company": "Plant Based Innovations, LLC", "company_location": "Leominster, MA, United States", "date": "2025-12-17", "report_date": "2026-02-04", "status": "Terminated", "distribution": "TX", "states": ["TX"], "nationwide": false, "quantity": "175 cases", "codes": "Lot 322 Expiration: 1/2/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0421-2026%22", "url": "https://recallledger.net/recalls/food-h-0421-2026-higher-harvest-by-h-e-b-brand-dairy-free-coconut-based-yogurt-strawb/"}, {"id": "fda-food-h-0419-2026", "source": "FDA", "category": "food", "recall_number": "H-0419-2026", "title": "McCafe Premium Roast Decaf Coffee K-Cup Pods recall (Keurig DR Pepper, Inc.)", "product": "McCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keurig Green Mountain, Inc. Burlington, MA 01803 U.S.A.", "reason": "Product is labeled as decaf, but might contain caffeine.", "hazard_level": "Class II", "company": "Keurig DR Pepper, Inc.", "company_location": "Knoxville, TN, United States", "date": "2025-12-06", "report_date": "2026-02-04", "status": "Terminated", "distribution": "CA, IN, NV", "states": ["CA", "IN", "NV"], "nationwide": false, "quantity": "960 cartons (84 pods/carton)", "codes": "Best By 17 NOV 2026  LA hh:mm  PL070 5321 or 5322 Batch Number: 5101564894 Material Number: 5000358463 ASIN: B07GCNDL91", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0419-2026%22", "url": "https://recallledger.net/recalls/food-h-0419-2026-mccafe-premium-roast-decaf-coffee-k-cup-pods-net-wt-29-oz-823g-pa/"}, {"id": "fda-food-h-0418-2026", "source": "FDA", "category": "food", "recall_number": "H-0418-2026", "title": "Qunol recall (QUTEN RESEARCH INSTITIUTE LLC)", "product": "Qunol, Extra Strength Turmeric Capsule, 1000mg ,HDPE bottle with cap, BIO7771\t120 count bottle, BIO7772 120 count bottle ,BIO8281 60 count bottle   .", "reason": "Mold contamination detected for raw material lots that were produced in July and used in finished goods.", "hazard_level": "Class II", "company": "QUTEN RESEARCH INSTITIUTE LLC", "company_location": "Pine Brook, NJ, United States", "date": "2025-12-16", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "The product was distributed to the following states: TX, FL, CA, NC, MI, MN, VA, NJ, MA, OH, IL,AL, CT, TN, NY, MO, PA, RI, SC, OK, GA, MN, WI, NV, IN, IA, CO, LA, NC, OR, KY, DE,", "states": ["AL", "CA", "CO", "CT", "DE", "FL", "GA", "IA", "IL", "IN", "KY", "LA", "MA", "MI", "MN", "MO", "NC", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "TN", "TX", "VA", "WI"], "nationwide": false, "quantity": "Turmeric 1000mg Capsule 60ct Veg., 3276,  Turmeric 1000mg Capsule, 120ct Veg. BJ ,10304,  Turmeric 1000mg Capsule 120ct Veg. 29160", "codes": "Part Number      Lot 12811C120      BIO7771 12811C120BJ     BIO7772 12811C60      BIO8281", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0418-2026%22", "url": "https://recallledger.net/recalls/food-h-0418-2026-qunol-extra-strength-turmeric-capsule-1000mg-hdpe-bottle-with-cap/"}, {"id": "fda-food-h-0417-2026", "source": "FDA", "category": "food", "recall_number": "H-0417-2026", "title": "SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz recall (BHARAT BAZAR)", "product": "SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539 Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586 Ingredients :- Natural Hing", "reason": "Undeclared wheat.", "hazard_level": "Class II", "company": "BHARAT BAZAR", "company_location": "Union City, CA, United States", "date": "2025-12-05", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "U.S. distribution: CA Foreign distribution: N/A", "states": ["CA"], "nationwide": false, "quantity": "180 packages (4-oz./package)", "codes": "Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0417-2026%22", "url": "https://recallledger.net/recalls/food-h-0417-2026-soma-kitchen-natural-asafoetida-net-wt-4-oz-0-25-lb-product-of-indi/"}, {"id": "fda-drug-d-0300-2026", "source": "FDA", "category": "drug", "recall_number": "D-0300-2026", "title": "Glycopyrrolate Oral Solution recall (NOVADOZ PHARMACEUTICALS LLC)", "product": "Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72", "reason": "Failed Impurities/Degradation Specifications", "hazard_level": "Class III", "company": "NOVADOZ PHARMACEUTICALS LLC", "company_location": "Piscataway, NJ, United States", "date": "2025-12-15", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2026%22", "url": "https://recallledger.net/recalls/drug-d-0300-2026-glycopyrrolate-oral-solution-1-mg-5-ml-16-oz-473-ml-rx-only-man/"}, {"id": "fda-drug-d-0298-2026", "source": "FDA", "category": "drug", "recall_number": "D-0298-2026", "title": "INON ACE Antacid tablets recall (Sato Pharmaceutical Co., Ltd)", "product": "INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01", "reason": "Failed Disintegration Specifications: above the time expected.", "hazard_level": "Class II", "company": "Sato Pharmaceutical Co., Ltd", "company_location": "Tokyo, N/A, Japan", "date": "2025-12-19", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "CA and HI", "states": ["CA", "HI"], "nationwide": false, "quantity": "3,640 bottles", "codes": "Lot#: PWXT, Exp 1/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0298-2026%22", "url": "https://recallledger.net/recalls/drug-d-0298-2026-inon-ace-antacid-tablets-magnesium-aluminosilicate-magnesium-hydroxi/"}, {"id": "fda-drug-d-0297-2026", "source": "FDA", "category": "drug", "recall_number": "D-0297-2026", "title": "parodontax recall (Haleon US Holdings LLC)", "product": "parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02", "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.", "hazard_level": "Class III", "company": "Haleon US Holdings LLC", "company_location": "Warren, NJ, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "84,764 bottles", "codes": "Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0297-2026%22", "url": "https://recallledger.net/recalls/drug-d-0297-2026-parodontax-cetylpyridinium-chloride-active-gum-health-mouthwash-min/"}, {"id": "fda-drug-d-0296-2026", "source": "FDA", "category": "drug", "recall_number": "D-0296-2026", "title": "Sterile Water for Irrigation recall (Baxter Healthcare Corporation)", "product": "Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.", "reason": "Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution", "hazard_level": "Class II", "company": "Baxter Healthcare Corporation", "company_location": "Deerfield, IL, United States", "date": "2025-12-22", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "125,496 bottles", "codes": "Lot #: G171359, expiry: 05/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2026%22", "url": "https://recallledger.net/recalls/drug-d-0296-2026-sterile-water-for-irrigation-250-ml-single-dose-plastic-bottle-rx-o/"}, {"id": "fda-device-z-1220-2026", "source": "FDA", "category": "device", "recall_number": "Z-1220-2026", "title": "BEAR Implant. Model Number: 1000. recall (Miach Orthopaedics)", "product": "BEAR Implant. Model Number: 1000.", "reason": "Incorrect expiration date on label that extends beyond the product's documented/approved shelf life.  With an incorrect expiration date, the UDI will also be incorrect.", "hazard_level": "Class II", "company": "Miach Orthopaedics", "company_location": "Westborough, MA, United States", "date": "2025-12-31", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.", "states": ["AK", "CA", "CO", "CT", "FL", "GA", "IL", "MA", "MD", "ME", "MI", "MN", "MO", "NC", "NJ", "NY", "OH", "OR", "TX", "VA", "WA", "WI"], "nationwide": true, "quantity": "284 units", "codes": "Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2026%22", "url": "https://recallledger.net/recalls/device-z-1220-2026-bear-implant-model-number-1000/"}, {"id": "fda-device-z-1219-2026", "source": "FDA", "category": "device", "recall_number": "Z-1219-2026", "title": "LSL Healthcare recall (LSL Healthcare Inc.)", "product": "LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit", "reason": "BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.", "hazard_level": "Class II", "company": "LSL Healthcare Inc.", "company_location": "Niles, IL, United States", "date": "2025-12-22", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of Idaho.", "states": ["ID"], "nationwide": true, "quantity": "1400 kits", "codes": "Lot Code: Model No. 2519CP; UDI-DI 00661392048157; Lot# 5G3119; Expiration Date 7/31/26 GTIN: (01)00661392048157(10)5G3119(17)260731", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2026%22", "url": "https://recallledger.net/recalls/device-z-1219-2026-lsl-healthcare-central-line-dressing-kit-model-catalog-number-2519c/"}, {"id": "fda-device-z-1218-2026", "source": "FDA", "category": "device", "recall_number": "Z-1218-2026", "title": "Brand Name: LimFlow Vector  Product Name: LimFlow Vector  Model/Catalog Number: VT-US-23 recall (LimFlow, Inc.)", "product": "Brand Name: LimFlow Vector  Product Name: LimFlow Vector  Model/Catalog Number: VT-US-23", "reason": "Incorrect expiration date", "hazard_level": "Class II", "company": "LimFlow, Inc.", "company_location": "San Jose, CA, United States", "date": "2025-12-05", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, CT, District of Columbia, FL, KY, MA, MI, NE, NJ, NY, OH, PA, RI, TX, WY.", "states": ["AL", "CT", "DC", "FL", "KY", "MA", "MI", "NE", "NJ", "NY", "OH", "PA", "RI", "TX", "WY"], "nationwide": true, "quantity": "33 units", "codes": "Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1218-2026%22", "url": "https://recallledger.net/recalls/device-z-1218-2026-brand-name-limflow-vector-product-name-limflow-vector-model-catalo/"}, {"id": "fda-device-z-1216-2026", "source": "FDA", "category": "device", "recall_number": "Z-1216-2026", "title": "SmartPath to dStream for XR and 3.0T.   Product Code recall (Philips North America)", "product": "SmartPath to dStream for XR and 3.0T.   Product Code (REF): 781270.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "3 units", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 781270.  UDI-DI: 00884838095083.  Serial Numbers: 24066, 38113, 17356.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2026%22", "url": "https://recallledger.net/recalls/device-z-1216-2026-smartpath-to-dstream-for-xr-and-3-0t-product-code-ref-781270/"}, {"id": "fda-device-z-1215-2026", "source": "FDA", "category": "device", "recall_number": "Z-1215-2026", "title": "SmartPath to dStream for 3.0T.   Product Code recall (Philips North America)", "product": "SmartPath to dStream for 3.0T.   Product Code (REF): 782145.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "1 unit", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 782145.  UDI-DI: 00884838108684.  Serial Numbers: 17385.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2026%22", "url": "https://recallledger.net/recalls/device-z-1215-2026-smartpath-to-dstream-for-3-0t-product-code-ref-782145-mr-syst/"}, {"id": "fda-device-z-1214-2026", "source": "FDA", "category": "device", "recall_number": "Z-1214-2026", "title": "Upgrade to MR 7700.   Product Code recall (Philips North America)", "product": "Upgrade to MR 7700.   Product Code (REF): 782130.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "6 units", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 782130.  UDI-DI: 00884838104402.  Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1214-2026%22", "url": "https://recallledger.net/recalls/device-z-1214-2026-upgrade-to-mr-7700-product-code-ref-782130-mr-systems-with-sw/"}, {"id": "fda-device-z-1213-2026", "source": "FDA", "category": "device", "recall_number": "Z-1213-2026", "title": "MR 7700.   Product Code recall (Philips North America)", "product": "MR 7700.   Product Code (REF): (1) 782120, (2) 782153.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "9 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65019, 65060, 65066, 65065, 65051, 65038, 65005.   (2) Product Code (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68010, 68017.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1213-2026%22", "url": "https://recallledger.net/recalls/device-z-1213-2026-mr-7700-product-code-ref-1-782120-2-782153-mr-systems-wi/"}, {"id": "fda-device-z-1212-2026", "source": "FDA", "category": "device", "recall_number": "Z-1212-2026", "title": "Ingenia Elition X.   Product Code recall (Philips North America)", "product": "Ingenia Elition X.   Product Code (REF): (1) 781358, (2) 782107, (3) 782136.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "31 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 781358; UDI-DI: 00884838088115; Serial Numbers: 45414, 45245, 45090, 45049, 45034, 45250, 45075, 45290, 45320, 45011, 45191, 45277, 45278, 45028, 45147.   (2) Product Code (REF): 782107; UDI-DI: 00884838098336; Serial Numbers: 62031, 45533, 62051, 62182, 62024, 62047, 62048, 62052, 45519, 62181, 62081, 62153, 62088, 45589, 62073.   (3) Product Code (REF): 782136; UDI-DI: 00884838108608; Serial Numbers: 28503.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2026%22", "url": "https://recallledger.net/recalls/device-z-1212-2026-ingenia-elition-x-product-code-ref-1-781358-2-782107-3-7/"}, {"id": "fda-device-z-1211-2026", "source": "FDA", "category": "device", "recall_number": "Z-1211-2026", "title": "Ingenia Elition S.   Product Code recall (Philips North America)", "product": "Ingenia Elition S.   Product Code (REF): (1) 781357, (2) 782106, (3)782137.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "5 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 781357; UDI-DI: 00884838088108; Serial Numbers: 46002.   (2) Product Code (REF): 782106; UDI-DI: 00884838098329; Serial Numbers: 46243, 46292.   (3) Product Code (REF): 782137; UDI-DI: 00884838108615; Serial Numbers: 64034, 64045.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1211-2026%22", "url": "https://recallledger.net/recalls/device-z-1211-2026-ingenia-elition-s-product-code-ref-1-781357-2-782106-3-78/"}, {"id": "fda-device-z-1210-2026", "source": "FDA", "category": "device", "recall_number": "Z-1210-2026", "title": "Ingenia Ambition X.   Product Code recall (Philips North America)", "product": "Ingenia Ambition X.   Product Code (REF): (1) 781356, (2) 782109, (3)782138.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "21 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 781356; UDI-DI: 00884838090040; Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029, 47189.   (2) Product Code (REF): 782109; UDI-DI: 00884838098350; Serial Numbers: 47849, 47634, 47534, 47726, 47760, 47706, 47789, 47642, 47681, 47761, 47771, 47767, 47862.   (3) Product Code (REF): 782138; UDI-DI: 00884838108622; Serial Numbers: 49057.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1210-2026%22", "url": "https://recallledger.net/recalls/device-z-1210-2026-ingenia-ambition-x-product-code-ref-1-781356-2-782109-3-7/"}, {"id": "fda-device-z-1209-2026", "source": "FDA", "category": "device", "recall_number": "Z-1209-2026", "title": "Ingenia Ambition S.   Product Code recall (Philips North America)", "product": "Ingenia Ambition S.   Product Code (REF): 782108.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "1 unit", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 782108.  UDI-DI: 00884838098343.  Serial Numbers: 48669.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2026%22", "url": "https://recallledger.net/recalls/device-z-1209-2026-ingenia-ambition-s-product-code-ref-782108-mr-systems-with-sw/"}, {"id": "fda-device-z-1208-2026", "source": "FDA", "category": "device", "recall_number": "Z-1208-2026", "title": "Ingenia 3.0T CX.   Product Code recall (Philips North America)", "product": "Ingenia 3.0T CX.   Product Code (REF): 781271.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "6 units", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 781271.  UDI-DI: 00884838068452.  Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2026%22", "url": "https://recallledger.net/recalls/device-z-1208-2026-ingenia-3-0t-cx-product-code-ref-781271-mr-systems-with-sw-ve/"}, {"id": "fda-device-z-1207-2026", "source": "FDA", "category": "device", "recall_number": "Z-1207-2026", "title": "Ingenia 3.0T.   Product Code recall (Philips North America)", "product": "Ingenia 3.0T.   Product Code (REF): (1) 781342, (2) 781377.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "24 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 781342; UDI-DI: 00884838055339; Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002, 71885, 71841, 71378, 71269, 85126, 71279, 71088, 71185, 71532, 71344, 71756, 71336, 71459.   (2) Product Code (REF): 781377; UDI-DI: 00884838009813; Serial Numbers: 42305, 42299, 42036, 42376, 42321.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1207-2026%22", "url": "https://recallledger.net/recalls/device-z-1207-2026-ingenia-3-0t-product-code-ref-1-781342-2-781377-mr-syste/"}, {"id": "fda-device-z-1206-2026", "source": "FDA", "category": "device", "recall_number": "Z-1206-2026", "title": "Ingenia 1.5T.   Product Code recall (Philips North America)", "product": "Ingenia 1.5T.   Product Code (REF): (1) 781341, (2) 781396.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "10 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433.   (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1206-2026%22", "url": "https://recallledger.net/recalls/device-z-1206-2026-ingenia-1-5t-product-code-ref-1-781341-2-781396-mr-syste/"}, {"id": "fda-device-z-1205-2026", "source": "FDA", "category": "device", "recall_number": "Z-1205-2026", "title": "Evolution Upgrade 3.0T.   Product Code recall (Philips North America)", "product": "Evolution Upgrade 3.0T.   Product Code (REF): 782143.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "1 unit", "codes": "MR systems with SW version R11.1 and R12.1.  Product Code (REF): 782143.  UDI-DI: 00884838108660.  Serial Numbers: 42225.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2026%22", "url": "https://recallledger.net/recalls/device-z-1205-2026-evolution-upgrade-3-0t-product-code-ref-782143-mr-systems-wit/"}, {"id": "fda-device-z-1204-2026", "source": "FDA", "category": "device", "recall_number": "Z-1204-2026", "title": "Evolution Upgrade 1.5T.   Product Codes recall (Philips North America)", "product": "Evolution Upgrade 1.5T.   Product Codes (REF): (1) 782148, (2) 782116.   MR systems with SW version R11.1 and R12.1.", "reason": "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-03", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.", "states": ["AZ", "CA", "CO", "IL", "MA", "ME", "MI", "MN", "MS", "NE", "NY", "OH", "OR", "PA", "SC", "TN", "TX", "VA", "VT", "WA"], "nationwide": true, "quantity": "3 units", "codes": "MR systems with SW version R11.1 and R12.1.  (1) Product Code (REF): 782148.  UDI-DI: 00884838108714.  Serial Numbers: 70769, 70983.    (2) Product Code (REF): 782116.  UDI-DI: 00884838099722.  Serial Number: 84741.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1204-2026%22", "url": "https://recallledger.net/recalls/device-z-1204-2026-evolution-upgrade-1-5t-product-codes-ref-1-782148-2-782116/"}, {"id": "fda-device-z-1203-2026", "source": "FDA", "category": "device", "recall_number": "Z-1203-2026", "title": "Chest Drainage Units and Accessories:    Product Code\tDescription    1.... recall (Cardinal Health 200, LLC)", "product": "Chest Drainage Units and Accessories:    Product Code\tDescription    1. 8888571562\tCardinal Health Sentinel Seal CDU  2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain  3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change  Connector  4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector  5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction  6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain  7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy  Change Connector  8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000  mL  9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)  10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL  11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL  12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber,  2500 mL", "reason": "The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.", "hazard_level": "Class II", "company": "Cardinal Health 200, LLC", "company_location": "Waukegan, IL, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.", "states": [], "nationwide": true, "quantity": "1,169,726 units", "codes": "All units affected by IFU update.  UDI-DI:  1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA)  2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA)  3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA)  4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA)  5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA)  6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA)  7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA)  8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA)  9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS)  10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA)  11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA)  12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2026%22", "url": "https://recallledger.net/recalls/device-z-1203-2026-chest-drainage-units-and-accessories-product-code-description-1/"}, {"id": "fda-device-z-1202-2026", "source": "FDA", "category": "device", "recall_number": "Z-1202-2026", "title": "Brand Name: Zimmer Tourniquet Systems  Product Name: A.T.S.¿ 3200TS Tourniquet Systems... recall (Zimmer Surgical Inc)", "product": "Brand Name: Zimmer Tourniquet Systems  Product Name: A.T.S.¿ 3200TS Tourniquet Systems  Model/Catalog Number: 60320010100  Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS  Product Description: A.T.S 3200TS Tourniquet Systems  Component: N/A", "reason": "Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.", "hazard_level": "Class II", "company": "Zimmer Surgical Inc", "company_location": "Dover, OH, United States", "date": "2025-12-24", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "International distribution to the countries of Canada and EMEA only.", "states": [], "nationwide": false, "quantity": "51", "codes": "Lot Code: Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739001\" ; Lot No. 67505739 ; Serial No. 32067505739001 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739003\" ; Lot No. 67505739 ; Serial No. 32067505739003 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739004\" ; Lot No. 67505739 ; Serial No. 32067505739004 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739005\" ; Lot No. 67505739 ; Serial No. 32067505739005 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739006\" ; Lot No. 67505739 ; Serial No. 32067505739006 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739007\" ; Lot No. 67505739 ; Serial No. 32067505739007 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739008\" ; Lot No. 67505739 ; Serial No. 32067505739008 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739010\" ; Lot No. 67505739 ; Serial No. 32067505739010 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739013\" ; Lot No. 67505739 ; Serial No. 32067505739013 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739014\" ; Lot No. 67505739 ; Serial No. 32067505739014 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739015\" ; Lot No. 67505739 ; Serial No. 32067505739015 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739017\" ; Lot No. 67505739 ; Serial No. 32067505739017 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739019\" ; Lot No. 67505739 ; Serial No. 32067505739019 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67505739(21)32067505739020\" ; Lot No. 67505739 ; Serial No. 32067505739020 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816001\" ; Lot No. 67508816 ; Serial No. 32067508816001 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816002\" ; Lot No. 67508816 ; Serial No. 32067508816002 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816003\" ; Lot No. 67508816 ; Serial No. 32067508816003 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816004\" ; Lot No. 67508816 ; Serial No. 32067508816004 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816005\" ; Lot No. 67508816 ; Serial No. 32067508816005 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816006\" ; Lot No. 67508816 ; Serial No. 32067508816006 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816007\" ; Lot No. 67508816 ; Serial No. 32067508816007 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816008\" ; Lot No. 67508816 ; Serial No. 32067508816008 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816009\" ; Lot No. 67508816 ; Serial No. 32067508816009 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816010\" ; Lot No. 67508816 ; Serial No. 32067508816010 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816012\" ; Lot No. 67508816 ; Serial No. 32067508816012 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816013\" ; Lot No. 67508816 ; Serial No. 32067508816013 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816014\" ; Lot No. 67508816 ; Serial No. 32067508816014 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816016\" ; Lot No. 67508816 ; Serial No. 32067508816016 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816017\" ; Lot No. 67508816 ; Serial No. 32067508816017 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816019\" ; Lot No. 67508816 ; Serial No. 32067508816019 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250725(10)67508816(21)32067508816020\" ; Lot No. 67508816 ; Serial No. 32067508816020 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820001\" ; Lot No. 67508820 ; Serial No. 32067508820001 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820002\" ; Lot No. 67508820 ; Serial No. 32067508820002 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820003\" ; Lot No. 67508820 ; Serial No. 32067508820003 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820004\" ; Lot No. 67508820 ; Serial No. 32067508820004 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820005\" ; Lot No. 67508820 ; Serial No. 32067508820005 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820006\" ; Lot No. 67508820 ; Serial No. 32067508820006 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820007\" ; Lot No. 67508820 ; Serial No. 32067508820007 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820008\" ; Lot No. 67508820 ; Serial No. 32067508820008 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820009\" ; Lot No. 67508820 ; Serial No. 32067508820009 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820010\" ; Lot No. 67508820 ; Serial No. 32067508820010 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820011\" ; Lot No. 67508820 ; Serial No. 32067508820011 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820012\" ; Lot No. 67508820 ; Serial No. 32067508820012 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820013\" ; Lot No. 67508820 ; Serial No. 32067508820013 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820014\" ; Lot No. 67508820 ; Serial No. 32067508820014 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820015\" ; Lot No. 67508820 ; Serial No. 32067508820015 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820016\" ; Lot No. 67508820 ; Serial No. 32067508820016 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820017\" ; Lot No. 67508820 ; Serial No. 32067508820017 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820018\" ; Lot No. 67508820 ; Serial No. 32067508820018 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820019\" ; Lot No. 67508820 ; Serial No. 32067508820019 Model No. 60320010100 ; UDI \"(01)00889024626447(11)250730(10)67508820(21)32067508820020\" ; Lot No. 67508820 ; Serial No. 32067508820020", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1202-2026%22", "url": "https://recallledger.net/recalls/device-z-1202-2026-brand-name-zimmer-tourniquet-systems-product-name-a-t-s-3200ts-to/"}, {"id": "fda-device-z-1201-2026", "source": "FDA", "category": "device", "recall_number": "Z-1201-2026", "title": "Brand Name: Zimmer Tourniquet Systems  Product Name: A.T.S.¿ 5000TS Tourniquet Systems... recall (Zimmer Surgical Inc)", "product": "Brand Name: Zimmer Tourniquet Systems  Product Name: A.T.S.¿ 5000TS Tourniquet Systems  Model/Catalog Number: 60500010100  Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS  Product Description: A.T.S 5000TS Tourniquet Systems  Component: N/A", "reason": "Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.", "hazard_level": "Class II", "company": "Zimmer Surgical Inc", "company_location": "Dover, OH, United States", "date": "2025-12-24", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "International distribution to the countries of Canada and EMEA only.", "states": [], "nationwide": false, "quantity": "206", "codes": "Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609003\" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609004\" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609005\" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610001\" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610002\" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610003\" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610004\" ; Lot No. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610005\" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611001\" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611002\" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611003\" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611004\" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611005\" ; Lot No. 66722611 ; Serial No. 50066722611005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611006\" ; Lot No. 66722611 ; Serial No. 50066722611006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611007\" ; Lot No. 66722611 ; Serial No. 50066722611007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611008\" ; Lot No. 66722611 ; Serial No. 50066722611008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611009\" ; Lot No. 66722611 ; Serial No. 50066722611009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611010\" ; Lot No. 66722611 ; Serial No. 50066722611010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892001\" ; Lot No. 66742892 ; Serial No. 50066742892001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892002\" ; Lot No. 66742892 ; Serial No. 50066742892002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892003\" ; Lot No. 66742892 ; Serial No. 50066742892003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892004\" ; Lot No. 66742892 ; Serial No. 50066742892004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892005\" ; Lot No. 66742892 ; Serial No. 50066742892005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892006\" ; Lot No. 66742892 ; Serial No. 50066742892006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892007\" ; Lot No. 66742892 ; Serial No. 50066742892007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892008\" ; Lot No. 66742892 ; Serial No. 50066742892008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892009\" ; Lot No. 66742892 ; Serial No. 50066742892009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892010\" ; Lot No. 66742892 ; Serial No. 50066742892010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892016\" ; Lot No. 66742892 ; Serial No. 50066742892016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893001\" ; Lot No. 66742893 ; Serial No. 50066742893001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893002\" ; Lot No. 66742893 ; Serial No. 50066742893002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893003\" ; Lot No. 66742893 ; Serial No. 50066742893003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893004\" ; Lot No. 66742893 ; Serial No. 50066742893004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893005\" ; Lot No. 66742893 ; Serial No. 50066742893005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893006\" ; Lot No. 66742893 ; Serial No. 50066742893006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893007\" ; Lot No. 66742893 ; Serial No. 50066742893007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893008\" ; Lot No. 66742893 ; Serial No. 50066742893008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893009\" ; Lot No. 66742893 ; Serial No. 50066742893009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893010\" ; Lot No. 66742893 ; Serial No. 50066742893010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893011\" ; Lot No. 66742893 ; Serial No. 50066742893011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893012\" ; Lot No. 66742893 ; Serial No. 50066742893012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893013\" ; Lot No. 66742893 ; Serial No. 50066742893013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893014\" ; Lot No. 66742893 ; Serial No. 50066742893014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893015\" ; Lot No. 66742893 ; Serial No. 50066742893015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893016\" ; Lot No. 66742893 ; Serial No. 50066742893016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893017\" ; Lot No. 66742893 ; Serial No. 50066742893017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893018\" ; Lot No. 66742893 ; Serial No. 50066742893018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893019\" ; Lot No. 66742893 ; Serial No. 50066742893019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893020\" ; Lot No. 66742893 ; Serial No. 50066742893020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087002\" ; Lot No. 66751087 ; Serial No. 50066751087002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087003\" ; Lot No. 66751087 ; Serial No. 50066751087003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087004\" ; Lot No. 66751087 ; Serial No. 50066751087004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087007\" ; Lot No. 66751087 ; Serial No. 50066751087007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087008\" ; Lot No. 66751087 ; Serial No. 50066751087008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087009\" ; Lot No. 66751087 ; Serial No. 50066751087009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087010\" ; Lot No. 66751087 ; Serial No. 50066751087010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087011\" ; Lot No. 66751087 ; Serial No. 50066751087011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087012\" ; Lot No. 66751087 ; Serial No. 50066751087012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087013\" ; Lot No. 66751087 ; Serial No. 50066751087013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087014\" ; Lot No. 66751087 ; Serial No. 50066751087014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087016\" ; Lot No. 66751087 ; Serial No. 50066751087016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087017\" ; Lot No. 66751087 ; Serial No. 50066751087017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087018\" ; Lot No. 66751087 ; Serial No. 50066751087018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087019\" ; Lot No. 66751087 ; Serial No. 50066751087019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797005\" ; Lot No. 66848797 ; Serial No. 50066848797005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797007\" ; Lot No. 66848797 ; Serial No. 50066848797007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797008\" ; Lot No. 66848797 ; Serial No. 50066848797008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797014\" ; Lot No. 66848797 ; Serial No. 50066848797014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797015\" ; Lot No. 66848797 ; Serial No. 50066848797015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799001\" ; Lot No. 66848799 ; Serial No. 50066848799001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799002\" ; Lot No. 66848799 ; Serial No. 50066848799002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799003\" ; Lot No. 66848799 ; Serial No. 50066848799003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799004\" ; Lot No. 66848799 ; Serial No. 50066848799004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799005\" ; Lot No. 66848799 ; Serial No. 50066848799005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799006\" ; Lot No. 66848799 ; Serial No. 50066848799006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799007\" ; Lot No. 66848799 ; Serial No. 50066848799007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799008\" ; Lot No. 66848799 ; Serial No. 50066848799008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799009\" ; Lot No. 66848799 ; Serial No. 50066848799009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799010\" ; Lot No. 66848799 ; Serial No. 50066848799010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799011\" ; Lot No. 66848799 ; Serial No. 50066848799011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799012\" ; Lot No. 66848799 ; Serial No. 50066848799012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799013\" ; Lot No. 66848799 ; Serial No. 50066848799013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799014\" ; Lot No. 66848799 ; Serial No. 50066848799014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799015\" ; Lot No. 66848799 ; Serial No. 50066848799015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799016\" ; Lot No. 66848799 ; Serial No. 50066848799016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799017\" ; Lot No. 66848799 ; Serial No. 50066848799017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799018\" ; Lot No. 66848799 ; Serial No. 50066848799018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799019\" ; Lot No. 66848799 ; Serial No. 50066848799019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799020\" ; Lot No. 66848799 ; Serial No. 50066848799020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330010\" ; Lot No. 66870330 ; Serial No. 50066870330010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330011\" ; Lot No. 66870330 ; Serial No. 50066870330011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330012\" ; Lot No. 66870330 ; Serial No. 50066870330012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330013\" ; Lot No. 66870330 ; Serial No. 50066870330013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330014\" ; Lot No. 66870330 ; Serial No. 50066870330014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330015\" ; Lot No. 66870330 ; Serial No. 50066870330015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330016\" ; Lot No. 66870330 ; Serial No. 50066870330016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330017\" ; Lot No. 66870330 ; Serial No. 50066870330017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330018\" ; Lot No. 66870330 ; Serial No. 50066870330018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330019\" ; Lot No. 66870330 ; Serial No. 50066870330019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240905(10)66959543(21)50066959543009\" ; Lot No. 66959543 ; Serial No. 50066959543009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025001\" ; Lot No. 66969025 ; Serial No. 50066969025001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025006\" ; Lot No. 66969025 ; Serial No. 50066969025006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025010\" ; Lot No. 66969025 ; Serial No. 50066969025010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025011\" ; Lot No. 66969025 ; Serial No. 50066969025011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025016\" ; Lot No. 66969025 ; Serial No. 50066969025016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)240918(10)66969027(21)50066969027008\" ; Lot No. 66969027 ; Serial No. 50066969027008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241021(10)66995371(21)50066995371013\" ; Lot No. 66995371 ; Serial No. 50066995371013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241021(10)66995371(21)50066995371014\" ; Lot No. 66995371 ; Serial No. 50066995371014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046297(21)50067046297014\" ; Lot No. 67046297 ; Serial No. 50067046297014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298014\" ; Lot No. 67046298 ; Serial No. 50067046298014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298015\" ; Lot No. 67046298 ; Serial No. 50067046298015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298016\" ; Lot No. 67046298 ; Serial No. 50067046298016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298018\" ; Lot No. 67046298 ; Serial No. 50067046298018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298019\" ; Lot No. 67046298 ; Serial No. 50067046298019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298020\" ; Lot No. 67046298 ; Serial No. 50067046298020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240003\" ; Lot No. 67071240 ; Serial No. 50067071240003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240005\" ; Lot No. 67071240 ; Serial No. 50067071240005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240008\" ; Lot No. 67071240 ; Serial No. 50067071240008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240011\" ; Lot No. 67071240 ; Serial No. 50067071240011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240012\" ; Lot No. 67071240 ; Serial No. 50067071240012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240014\" ; Lot No. 67071240 ; Serial No. 50067071240014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240018\" ; Lot No. 67071240 ; Serial No. 50067071240018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765001\" ; Lot No. 67117765 ; Serial No. 50067117765001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765002\" ; Lot No. 67117765 ; Serial No. 50067117765002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765003\" ; Lot No. 67117765 ; Serial No. 50067117765003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765004\" ; Lot No. 67117765 ; Serial No. 50067117765004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765005\" ; Lot No. 67117765 ; Serial No. 50067117765005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765007\" ; Lot No. 67117765 ; Serial No. 50067117765007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765008\" ; Lot No. 67117765 ; Serial No. 50067117765008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765009\" ; Lot No. 67117765 ; Serial No. 50067117765009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765010\" ; Lot No. 67117765 ; Serial No. 50067117765010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765011\" ; Lot No. 67117765 ; Serial No. 50067117765011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765019\" ; Lot No. 67117765 ; Serial No. 50067117765019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765020\" ; Lot No. 67117765 ; Serial No. 50067117765020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766002\" ; Lot No. 67117766 ; Serial No. 50067117766002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766007\" ; Lot No. 67117766 ; Serial No. 50067117766007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766008\" ; Lot No. 67117766 ; Serial No. 50067117766008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766013\" ; Lot No. 67117766 ; Serial No. 50067117766013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766014\" ; Lot No. 67117766 ; Serial No. 50067117766014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768002\" ; Lot No. 67117768 ; Serial No. 50067117768002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768004\" ; Lot No. 67117768 ; Serial No. 50067117768004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768005\" ; Lot No. 67117768 ; Serial No. 50067117768005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768006\" ; Lot No. 67117768 ; Serial No. 50067117768006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768007\" ; Lot No. 67117768 ; Serial No. 50067117768007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768008\" ; Lot No. 67117768 ; Serial No. 50067117768008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768009\" ; Lot No. 67117768 ; Serial No. 50067117768009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768010\" ; Lot No. 67117768 ; Serial No. 50067117768010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768011\" ; Lot No. 67117768 ; Serial No. 50067117768011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768012\" ; Lot No. 67117768 ; Serial No. 50067117768012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768013\" ; Lot No. 67117768 ; Serial No. 50067117768013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768014\" ; Lot No. 67117768 ; Serial No. 50067117768014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768015\" ; Lot No. 67117768 ; Serial No. 50067117768015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768017\" ; Lot No. 67117768 ; Serial No. 50067117768017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768018\" ; Lot No. 67117768 ; Serial No. 50067117768018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667001\" ; Lot No. 67482667 ; Serial No. 50067482667001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667002\" ; Lot No. 67482667 ; Serial No. 50067482667002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667003\" ; Lot No. 67482667 ; Serial No. 50067482667003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667004\" ; Lot No. 67482667 ; Serial No. 50067482667004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667005\" ; Lot No. 67482667 ; Serial No. 50067482667005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667006\" ; Lot No. 67482667 ; Serial No. 50067482667006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667007\" ; Lot No. 67482667 ; Serial No. 50067482667007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667008\" ; Lot No. 67482667 ; Serial No. 50067482667008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667009\" ; Lot No. 67482667 ; Serial No. 50067482667009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667010\" ; Lot No. 67482667 ; Serial No. 50067482667010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667012\" ; Lot No. 67482667 ; Serial No. 50067482667012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667013\" ; Lot No. 67482667 ; Serial No. 50067482667013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667014\" ; Lot No. 67482667 ; Serial No. 50067482667014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667015\" ; Lot No. 67482667 ; Serial No. 50067482667015 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667016\" ; Lot No. 67482667 ; Serial No. 50067482667016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667017\" ; Lot No. 67482667 ; Serial No. 50067482667017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667018\" ; Lot No. 67482667 ; Serial No. 50067482667018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667019\" ; Lot No. 67482667 ; Serial No. 50067482667019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667020\" ; Lot No. 67482667 ; Serial No. 50067482667020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336002\" ; Lot No. 67533336 ; Serial No. 50067533336002 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336003\" ; Lot No. 67533336 ; Serial No. 50067533336003 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336004\" ; Lot No. 67533336 ; Serial No. 50067533336004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336005\" ; Lot No. 67533336 ; Serial No. 50067533336005 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336006\" ; Lot No. 67533336 ; Serial No. 50067533336006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336007\" ; Lot No. 67533336 ; Serial No. 50067533336007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336008\" ; Lot No. 67533336 ; Serial No. 50067533336008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336009\" ; Lot No. 67533336 ; Serial No. 50067533336009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336010\" ; Lot No. 67533336 ; Serial No. 50067533336010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336012\" ; Lot No. 67533336 ; Serial No. 50067533336012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336013\" ; Lot No. 67533336 ; Serial No. 50067533336013 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336016\" ; Lot No. 67533336 ; Serial No. 50067533336016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336017\" ; Lot No. 67533336 ; Serial No. 50067533336017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336020\" ; Lot No. 67533336 ; Serial No. 50067533336020 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250902(10)67542546(21)50067542546012\" ; Lot No. 67542546 ; Serial No. 50067542546012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250902(10)67542546(21)50067542546018\" ; Lot No. 67542546 ; Serial No. 50067542546018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349001\" ; Lot No. 67553349 ; Serial No. 50067553349001 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349004\" ; Lot No. 67553349 ; Serial No. 50067553349004 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349006\" ; Lot No. 67553349 ; Serial No. 50067553349006 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349007\" ; Lot No. 67553349 ; Serial No. 50067553349007 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349008\" ; Lot No. 67553349 ; Serial No. 50067553349008 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349009\" ; Lot No. 67553349 ; Serial No. 50067553349009 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349010\" ; Lot No. 67553349 ; Serial No. 50067553349010 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349011\" ; Lot No. 67553349 ; Serial No. 50067553349011 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349012\" ; Lot No. 67553349 ; Serial No. 50067553349012 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349014\" ; Lot No. 67553349 ; Serial No. 50067553349014 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349016\" ; Lot No. 67553349 ; Serial No. 50067553349016 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349017\" ; Lot No. 67553349 ; Serial No. 50067553349017 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349018\" ; Lot No. 67553349 ; Serial No. 50067553349018 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349019\" ; Lot No. 67553349 ; Serial No. 50067553349019 Model No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349020\" ; Lot No. 67553349 ; Serial No. 50067553349020", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2026%22", "url": "https://recallledger.net/recalls/device-z-1201-2026-brand-name-zimmer-tourniquet-systems-product-name-a-t-s-5000ts-to/"}, {"id": "fda-device-z-1200-2026", "source": "FDA", "category": "device", "recall_number": "Z-1200-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tWATKINS SPINE PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tWATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M;   2)\tSM-SPINE PACK-LF, Kit SKU DYNJ0395037X;   3)\tTOTAL HIP PACK, Kit SKU DYNJ04809N;   4)\tMAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN;   5)\tSCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q;   6)\tORTHO SPINE, Kit SKU DYNJ40221G;   7)\tURO GYN PACK, Kit SKU DYNJ45311J;   8)\tLAMINECTOMY PACK, Kit SKU DYNJ46330C;   9)\tDJ ORTHO SPINE, Kit SKU DYNJ48980M;   10)\tCERVICAL PACK, Kit SKU DYNJ52995F;   11)\tNORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L;   12)\tKNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B;   13)\tKNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150;   14)\tHIP PACK, Kit SKU DYNJ66630;   15)\tOHNS FREE FLAP A PACK, Kit SKU DYNJ69065F;   16)\tLUMBAR PACK, Kit SKU DYNJ69113C;   17)\tLAMINECTOMY PACK, Kit SKU DYNJ69401D;   18)\tLAMINECTOMY PACK, Kit SKU DYNJ81013D;   19)\tHIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A;   20)\tFLASC ACL PACK, Kit SKU DYNJ88971;   21)\tSPINE PACK MERCY GALENA, Kit SKU DYNJ89943;   22)\tSPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J;   23)\tHAND, Kit SKU DYNJ904945G;   24)\tLAMINECTOMY, Kit SKU DYNJ909505D;   25)\tSHOULDER SPLIT, Kit SKU DYNJ910543F;   26)\tSHOULDER SPLIT, Kit SKU DYNJ910543G;   27)\tCRANIOTOMY PACK, Kit SKU DYNJT4724;   28)\tSPINE PACK, Kit SKU DYNJT5184.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "117 units", "codes": "Medline Kit SKU DYNJ0275635M:  UDI/DI 10198459464799 (EA) 40198459464790 (CS), Lot Number 25KMH120;  Medline Kit SKU DYNJ0395037X:  UDI/DI 10198459600555 (EA) 40198459600556 (CS), Lot Number 25LMB119;  Medline Kit SKU DYNJ04809N:  UDI/DI 10198459440908 (EA) 40198459440909 (CS), Lot Number 25KMF969;  Medline Kit SKU DYNJ0565499AN:  UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25JMF339;  Medline Kit SKU DYNJ0565499AN:  UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25LMB019;  Medline Kit SKU DYNJ27164Q:  UDI/DI 10198459138102 (EA) 40198459138103 (CS), Lot Number 25KMJ742;  Medline Kit SKU DYNJ40221G:  UDI/DI 10198459448515 (EA) 40198459448516 (CS), Lot Number 25KME669;  Medline Kit SKU DYNJ45311J:  UDI/DI 10198459255670 (EA) 40198459255671 (CS), Lot Number 25KMI080;  Medline Kit SKU DYNJ46330C:  UDI/DI 10889942490066 (EA) 40889942490067 (CS), Lot Number 25KMD795;  Medline Kit SKU DYNJ48980M:  UDI/DI 10195327533694 (EA) 40195327533695 (CS), Lot Number 25KMC459;  Medline Kit SKU DYNJ52995F:  UDI/DI 10195327639778 (EA) 40195327639779 (CS), Lot Number 25KME064;  Medline Kit SKU DYNJ56483L:  UDI/DI 10195327518141 (EA) 40195327518142 (CS), Lot Number 25LMB049;  Medline Kit SKU DYNJ61200B:  UDI/DI 10195327604264 (EA) 40195327604265 (CS), Lot Number 25KBE867;  Medline Kit SKU DYNJ66150:  UDI/DI 10193489317558 (EA) 40193489317559 (CS), Lot Number 25KMC057;  Medline Kit SKU DYNJ66630:  UDI/DI 10193489368284 (EA) 40193489368285 (CS), Lot Number 25KMG435;  Medline Kit SKU DYNJ69065F:  UDI/DI 10198459226618 (EA) 40198459226619 (CS), Lot Number 25KMI293;  Medline Kit SKU DYNJ69113C:  UDI/DI 10198459170225 (EA) 40198459170226 (CS), Lot Number 25JMJ726;  Medline Kit SKU DYNJ69401D:  UDI/DI 10198459183676 (EA) 40198459183677 (CS), Lot Number 25KMJ106;  Medline Kit SKU DYNJ81013D:  UDI/DI 10198459547706 (EA) 40198459547707 (CS), Lot Number 25LDA122;  Medline Kit SKU DYNJ84275A:  UDI/DI 10198459240171 (EA) 40198459240172 (CS), Lot Number 25LMB546;  Medline Kit SKU DYNJ88971:  UDI/DI 10198459222269 (EA) 40198459222260 (CS), Lot Number 25KMH340;  Medline Kit SKU DYNJ89943:  UDI/DI 10198459299483 (EA) 40198459299484 (CS), Lot Number 25KMB583;  Medline Kit SKU DYNJ900173J:  UDI/DI 10198459292170 (EA) 40198459292171 (CS), Lot Number 25JDB487;  Medline Kit SKU DYNJ904945G:  UDI/DI 10198459518317 (EA) 40198459518318 (CS), Lot Number 25LBC198;  Medline Kit SKU DYNJ909505D:  UDI/DI 10198459594229 (EA) 40198459594220 (CS), Lot Number 25LMB637;  Medline Kit SKU DYNJ910543F:  UDI/DI 10198459554971 (EA) 40198459554972 (CS), Lot Number 25KMH376;  Medline Kit SKU DYNJ910543G:  UDI/DI 10198459588204 (EA) 40198459588205 (CS), Lot Number 25LMA619;  Medline Kit SKU DYNJT4724:  UDI/DI 10198459457913 (EA) 40198459457914 (CS), Lot Number 25KMI923;  Medline Kit SKU DYNJT5184:  UDI/DI 10198459467592 (EA) 40198459467593 (CS), Lot Number 25KMG240.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2026%22", "url": "https://recallledger.net/recalls/device-z-1200-2026-medline-medical-procedure-convenience-kits-labeled-as-1-watkins-s/"}, {"id": "fda-device-z-1199-2026", "source": "FDA", "category": "device", "recall_number": "Z-1199-2026", "title": "Medline medical procedure convenience kits labeled as:    1) C-SECTION PACK recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) C-SECTION PACK, Kit SKU DYNJ35494C;   2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O;   3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "96 units", "codes": "Medline Kit SKU DYNJ35494C:  UDI/DI 10198459117879 (EA) 40198459117870 (CS), Lot Number 25KMD420;  Medline Kit SKU DYNJ38582O:  UDI/DI 10198459603709 (EA) 40198459603700 (CS), Lot Number 25KMI679;  Medline Kit SKU DYNJ82084F:  UDI/DI 10198459089206 (EA) 40198459089207 (CS), Lot Number 25KMD145.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1199-2026%22", "url": "https://recallledger.net/recalls/device-z-1199-2026-medline-medical-procedure-convenience-kits-labeled-as-1-c-section/"}, {"id": "fda-device-z-1198-2026", "source": "FDA", "category": "device", "recall_number": "Z-1198-2026", "title": "Medline medical procedure convenience kits labeled as:  CIRCUMCISION PACK recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:  CIRCUMCISION PACK, Kit SKU DYNJ16826O", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU DYNJ16826O:  UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25LMA655;  Medline Kit SKU DYNJ16826O:  UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25KMC911.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1198-2026%22", "url": "https://recallledger.net/recalls/device-z-1198-2026-medline-medical-procedure-convenience-kits-labeled-as-circumcision-p/"}, {"id": "fda-device-z-1197-2026", "source": "FDA", "category": "device", "recall_number": "Z-1197-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tRR-GYN LAPAROSCOPY PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tRR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O;   2)\tPELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q;   3)\tDIVA PACK, Kit SKU DYNJ04811O;   4)\tDA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S;   5)\tMH ROBOTICS PACK, Kit SKU DYNJ50880L;   6)\tDELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B;   7)\tROBOT PACK, Kit SKU DYNJ82761B;   8)\tGENERAL ROBOTICS PACK, Kit SKU DYNJT4964.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU DYNJ0395022O:  UDI/DI 10195327634827 (EA) 40195327634828 (CS), Lot Number 25KME682;  Medline Kit SKU DYNJ0415776Q:  UDI/DI 10198459566806 (EA) 40198459566807 (CS), Lot Number 25KMH125;  Medline Kit SKU DYNJ04811O:  UDI/DI 10198459440953 (EA) 40198459440954 (CS), Lot Number 25KMD772;  Medline Kit SKU DYNJ44864S:  UDI/DI 10195327127626 (EA) 40195327127627 (CS), Lot Number 25LMA115;  Medline Kit SKU DYNJ50880L:  UDI/DI 10198459388002 (EA) 40198459388003 (CS), Lot Number 25LMA516;  Medline Kit SKU DYNJ82244B:  UDI/DI 10198459344053 (EA) 40198459344054 (CS), Lot Number 25KMF328;  Medline Kit SKU DYNJ82761B:  UDI/DI 10198459039232 (EA) 40198459039233 (CS), Lot Number 25LMA391;  Medline Kit SKU DYNJT4964:  UDI/DI 10198459460098 (EA) 40198459460099 (CS), Lot Number 25KMJ341.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1197-2026%22", "url": "https://recallledger.net/recalls/device-z-1197-2026-medline-medical-procedure-convenience-kits-labeled-as-1-rr-gyn-la/"}, {"id": "fda-device-z-1196-2026", "source": "FDA", "category": "device", "recall_number": "Z-1196-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tDEPAUL BASIC NEURO-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tDEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L;   2)\tNEURO MINOR PACK, Kit SKU DYNJ46546M;   3)\tNEURO SHUNT PACK, Kit SKU DYNJ54396K;   4)\tNEURO PACK, Kit SKU DYNJ59397Q;   5)\tNEURO BASIC, Kit SKU DYNJ904052L;   6)\tPK NEURO SHUNT BUMC, Kit SKU DYNJT6428.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "236 units", "codes": "Medline Kit SKU DYNJ20028L:  UDI/DI 10198459228995 (EA) 40198459228996 (CS), Lot Number 25LMA824;  Medline Kit SKU DYNJ46546M:  UDI/DI 10198459526404 (EA) 40198459526405 (CS), Lot Number 25KMH940;  Medline Kit SKU DYNJ54396K:  UDI/DI 10198459443138 (EA) 40198459443139 (CS), Lot Number 25KMD804;  Medline Kit SKU DYNJ59397Q:  UDI/DI 10198459495427 (EA) 40198459495428 (CS), Lot Number 25KMC287;  Medline Kit SKU DYNJ904052L:  UDI/DI 10198459231339 (EA) 40198459231330 (CS), Lot Number 25JDB033;  Medline Kit SKU DYNJT6428:  UDI/DI 10198459553660 (EA) 40198459553661 (CS), Lot Number 25KMD463.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1196-2026%22", "url": "https://recallledger.net/recalls/device-z-1196-2026-medline-medical-procedure-convenience-kits-labeled-as-1-depaul-ba/"}, {"id": "fda-device-z-1195-2026", "source": "FDA", "category": "device", "recall_number": "Z-1195-2026", "title": "Medline medical procedure convenience kits labeled as:    1) INPATIENT CTRL LN DRG CHG recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880;   2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU DT22880:  UDI/DI 10653160995470 (EA) 40653160995471 (CS), Lot Number 25KMJ441;  Medline Kit SKU DYNDC3283A:  UDI/DI 10198459313240 (EA) 40198459313241 (CS), Lot Number 25KMH515.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1195-2026%22", "url": "https://recallledger.net/recalls/device-z-1195-2026-medline-medical-procedure-convenience-kits-labeled-as-1-inpatient/"}, {"id": "fda-device-z-1194-2026", "source": "FDA", "category": "device", "recall_number": "Z-1194-2026", "title": "Medline medical procedure convenience kits labeled as:  HEAD SHAVE-LATEX SAFE KIT recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:  HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "60 units", "codes": "Medline Kit SKU P903933B:  UDI/DI 10889942362080 (EA) 40889942362081 (CS), Lot Number 25KMA871", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1194-2026%22", "url": "https://recallledger.net/recalls/device-z-1194-2026-medline-medical-procedure-convenience-kits-labeled-as-head-shave-lat/"}, {"id": "fda-device-z-1193-2026", "source": "FDA", "category": "device", "recall_number": "Z-1193-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tDRAWER 1 AIRWAY recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tDRAWER 1 AIRWAY, Kit SKU ACC010270A;   2)\tDRAWER 2, Kit SKU ACC010690;   3)\tDRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073;   4)\tHYPOSPADIUS PACK, Kit SKU DYNJ00282Q;   5)\tSJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K;   6)\tCENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S;   7)\tSPINE PACK-LF, Kit SKU DYNJ0376635Q;   8)\tORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T;   9)\tW.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J;   10)\tNEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W;   11)\tANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T;   12)\tMINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P;   13)\tKNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R;   14)\tPEDIATRIC PACK-LF, Kit SKU DYNJ28212L;   15)\tANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P;   16)\tPEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J;   17)\tLAPAROSCOPY PACK, Kit SKU DYNJ39215N;   18)\tMAJOR LAP VCH, Kit SKU DYNJ39217P;   19)\tNEURO PACK, Kit SKU DYNJ39220N;   20)\tCAS HAND PK, Kit SKU DYNJ39468G;   21)\tRFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B;   22)\tPED OPEN HEART PACK, Kit SKU DYNJ45373G;   23)\tMAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F;   24)\tMINOR PK-LF, Kit SKU DYNJ51437C;   25)\tVEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C;   26)\tSHOULDER PACK, Kit SKU DYNJ56889B;   27)\tLAP CHOLE PACK, Kit SKU DYNJ57206F;   28)\tTRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I;   29)\tSHOULDER ARTH PACK, Kit SKU DYNJ58410D;   30)\tMAJOR PACK, Kit SKU DYNJ58528J;   31)\tPACK BREAST, Kit SKU DYNJ60157F;   32)\tCH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I;   33)\tRR-SPINE PACK, Kit SKU DYNJ62643B;   34)\tMINOR PACK, Kit SKU DYNJ64238D;   35)\tPBMS NECK PACK-LF, Kit SKU DYNJ64961C;   36)\tBREAST PACK, Kit SKU DYNJ64988C;   37)\tMINOR PACK 180110, Kit SKU DYNJ65447C;   38)\tPACK,V-P SHUNT, Kit SKU DYNJ65472C;   39)\tBASIC PACK, Kit SKU DYNJ65996D;   40)\tMINOR SS, Kit SKU DYNJ66094A;   41)\tCRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D;   42)\tPEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F;   43)\tURO/GYN PACK, Kit SKU DYNJ66675F;   44)\tSHOULDER SCOPE PACK, Kit SKU DYNJ68707B;   45)\tSPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B;   46)\tSPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C;   47)\tACF PACK, Kit SKU DYNJ69112C;   48)\tSM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C;   49)\tSHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C;   50)\tC BIRTH SET UP PACK, Kit SKU DYNJ81994C;   51)\tTRIAL PACK, Kit SKU DYNJ82770A;   52)\tPROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C;   53)\tHAND PACK, Kit SKU DYNJ85033A;   54)\tARTHROSCOPY PACK, Kit SKU DYNJ85197A;   55)\tGU-GYN-LITHO PACK, Kit SKU DYNJ86013A;   56)\tDBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A;   57)\tBREAST PACK, Kit SKU DYNJ87587A;   58)\tPACK,PEDIATRIC MINOR, Kit SKU DYNJ88718;   59)\tUNIVERSAL-ASC, Kit SKU DYNJ900071C;   60)\tBASIC, Kit SKU DYNJ905869G;   61)\tPACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F;   62)\tHAND/FOOT PACK, Kit SKU DYNJT3131A;   63)\tSHOULDER PACK, Kit SKU DYNJT3266;   64)\tLUMBAR PACK, Kit SKU DYNJT4178;   65)\tCVS ICU PACK, Kit SKU PHS41728D;   66)\tSINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "857 units", "codes": "Medline Kit SKU ACC010270A:  UDI/DI 10889942219827 (EA) 40889942219828 (CS), Lot Number 25LDA153;  Medline Kit SKU ACC010690:  UDI/DI 10195327433307 (EA) 40195327433308 (CS), Lot Number 25LDA088;  Medline Kit SKU ACC011073:  UDI/DI 10198459569333 (EA) 40198459569334 (CS), Lot Number 25LDA072;  Medline Kit SKU DYNJ00282Q:  UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25KMC904;  Medline Kit SKU DYNJ00282Q:  UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25LMA071;  Medline Kit SKU DYNJ0101360K:  UDI/DI 10195327662066 (EA) 40195327662067 (CS), Lot Number 25KMC709;  Medline Kit SKU DYNJ0220136S:  UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25KMB403;  Medline Kit SKU DYNJ0220136S:  UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25JMF503;  Medline Kit SKU DYNJ0376635Q:  UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMH121;  Medline Kit SKU DYNJ0376635Q:  UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMF780;  Medline Kit SKU DYNJ0460768T:  UDI/DI 10198459466809 (EA) 40198459466800 (CS), Lot Number 25KMH789;  Medline Kit SKU DYNJ0509186J:  UDI/DI 10198459117626 (EA) 40198459117627 (CS), Lot Number 25KME895;  Medline Kit SKU DYNJ0578815W:  UDI/DI 10198459466892 (EA) 40198459466893 (CS), Lot Number 25JMJ695;  Medline Kit SKU DYNJ0610290T:  UDI/DI 10198459021558 (EA) 40198459021559 (CS), Lot Number 25KMC723;  Medline Kit SKU DYNJ0753436P:  UDI/DI 10198459466854 (EA) 40198459466855 (CS), Lot Number 25KMJ740;  Medline Kit SKU DYNJ0890502R:  UDI/DI 10198459431098 (EA) 40198459431099 (CS), Lot Number 25KME522;  Medline Kit SKU DYNJ28212L:  UDI/DI 10193489322118 (EA) 40193489322119 (CS), Lot Number 25KBE916;  Medline Kit SKU DYNJ31341P:  UDI/DI 10198459069352 (EA) 40198459069353 (CS), Lot Number 25KMA795;  Medline Kit SKU DYNJ37615J:  UDI/DI 10195327560881 (EA) 40195327560882 (CS), Lot Number 25KDB706;  Medline Kit SKU DYNJ39215N:  UDI/DI 10198459102240 (EA) 40198459102241 (CS), Lot Number 25KMH027;  Medline Kit SKU DYNJ39217P:  UDI/DI 10198459102356 (EA) 40198459102357 (CS), Lot Number 25LMA409;  Medline Kit SKU DYNJ39220N:  UDI/DI 10198459102387 (EA) 40198459102388 (CS), Lot Number 25KMJ608;  Medline Kit SKU DYNJ39468G:  UDI/DI 10198459408595 (EA) 40198459408596 (CS), Lot Number 25KMD121;  Medline Kit SKU DYNJ43954B:  UDI/DI 10193489509168 (EA) 40193489509169 (CS), Lot Number 25KMD726;  Medline Kit SKU DYNJ45373G:  UDI/DI 10198459254635 (EA) 40198459254636 (CS), Lot Number 25JMH775;  Medline Kit SKU DYNJ51436F:  UDI/DI 10198459004315 (EA) 40198459004316 (CS), Lot Number 25KMG978;  Medline Kit SKU DYNJ51437C:  UDI/DI 10198459005114 (EA) 40198459005115 (CS), Lot Number 25JMJ673;  Medline Kit SKU DYNJ52586C:  UDI/DI 10195327596521 (EA) 40195327596522 (CS), Lot Number 25KMH637;  Medline Kit SKU DYNJ56889B:  UDI/DI 10198459490088 (EA) 40198459490089 (CS), Lot Number 25KBE707;  Medline Kit SKU DYNJ57206F:  UDI/DI 10195327682958 (EA) 40195327682959 (CS), Lot Number 25KMG080;  Medline Kit SKU DYNJ58257I:  UDI/DI 10198459565526 (EA) 40198459565527 (CS), Lot Number 25LMA492;  Medline Kit SKU DYNJ58410D:  UDI/DI 10198459366468 (EA) 40198459366469 (CS), Lot Number 25KBF113;  Medline Kit SKU DYNJ58528J:  UDI/DI 10198459322815 (EA) 40198459322816 (CS), Lot Number 25JBW494;  Medline Kit SKU DYNJ60157F:  UDI/DI 10198459343445 (EA) 40198459343446 (CS), Lot Number 25KMI064;  Medline Kit SKU DYNJ61696I:  UDI/DI 10198459208713 (EA) 40198459208714 (CS), Lot Number 25KMF819;  Medline Kit SKU DYNJ62643B:  UDI/DI 10198459164446 (EA) 40198459164447 (CS), Lot Number 25KMB841;  Medline Kit SKU DYNJ64238D:  UDI/DI 10198459068447 (EA) 40198459068448 (CS), Lot Number 25KME422;  Medline Kit SKU DYNJ64961C:  UDI/DI 10198459569777 (EA) 40198459569778 (CS), Lot Number 25KMD570;  Medline Kit SKU DYNJ64988C:  UDI/DI 10198459373008 (EA) 40198459373009 (CS), Lot Number 25LMB275;  Medline Kit SKU DYNJ65447C:  UDI/DI 10198459605222 (EA) 40198459605223 (CS), Lot Number 25LMA822;  Medline Kit SKU DYNJ65472C:  UDI/DI 10198459168727 (EA) 40198459168728 (CS), Lot Number 25KMD067;  Medline Kit SKU DYNJ65996D:  UDI/DI 10198459376726 (EA) 40198459376727 (CS), Lot Number 25KMJ550;  Medline Kit SKU DYNJ66094A:  UDI/DI 10198459462689 (EA) 40198459462680 (CS), Lot Number 25LMB276;  Medline Kit SKU DYNJ66613D:  UDI/DI 10198459504488 (EA) 40198459504489 (CS), Lot Number 25KMI271;  Medline Kit SKU DYNJ66644F:  UDI/DI 10198459574160 (EA) 40198459574161 (CS), Lot Number 25KMD640;  Medline Kit SKU DYNJ66675F:  UDI/DI 10198459574108 (EA) 40198459574109 (CS), Lot Number 25LMA853;  Medline Kit SKU DYNJ68707B:  UDI/DI 10198459001734 (EA) 40198459001735 (CS), Lot Number 25KBE843;  Medline Kit SKU DYNJ68844B:  UDI/DI 10198459232428 (EA) 40198459232429 (CS), Lot Number 25KMF829;  Medline Kit SKU DYNJ68844C:  UDI/DI 10198459608360 (EA) 40198459608361 (CS), Lot Number 25LMA922;  Medline Kit SKU DYNJ69112C:  UDI/DI 10198459176128 (EA) 40198459176129 (CS), Lot Number 25KME071;  Medline Kit SKU DYNJ69705C:  UDI/DI 10198459164460 (EA) 40198459164461 (CS), Lot Number 25LMB062;  Medline Kit SKU DYNJ81752C:  UDI/DI 10198459272721 (EA) 40198459272722 (CS), Lot Number 25KDB800;  Medline Kit SKU DYNJ81994C:  UDI/DI 10198459105203 (EA) 40198459105204 (CS), Lot Number 25KMH388;  Medline Kit SKU DYNJ82770A:  UDI/DI 10198459411755 (EA) 40198459411756 (CS), Lot Number 25JME725;  Medline Kit SKU DYNJ84120C:  UDI/DI 10198459574177 (EA) 40198459574178 (CS), Lot Number 25KMB382;  Medline Kit SKU DYNJ85033A:  UDI/DI 10195327605629 (EA) 40195327605620 (CS), Lot Number 25KMI735;  Medline Kit SKU DYNJ85197A:  UDI/DI 10198459217395 (EA) 40198459217396 (CS), Lot Number 25JMD376;  Medline Kit SKU DYNJ86013A:  UDI/DI 10198459133527 (EA) 40198459133528 (CS), Lot Number 25LDA111;  Medline Kit SKU DYNJ86963A:  UDI/DI 10198459573330 (EA) 40198459573331 (CS), Lot Number 25KMD001;  Medline Kit SKU DYNJ87587A:  UDI/DI 10198459114199 (EA) 40198459114190 (CS), Lot Number 25KBE931;  Medline Kit SKU DYNJ88718:  UDI/DI 10198459195099 (EA) 40198459195090 (CS), Lot Number 25KMF429;  Medline Kit SKU DYNJ900071C:  UDI/DI 10198459121722 (EA) 40198459121723 (CS), Lot Number 25KMH899;  Medline Kit SKU DYNJ905869G:  UDI/DI 10198459394577 (EA) 40198459394578 (CS), Lot Number 25JBX559;  Medline Kit SKU DYNJ906888F:  UDI/DI 10198459194764 (EA) 40198459194765 (CS), Lot Number 25LMA693;  Medline Kit SKU DYNJT3131A:  UDI/DI 10198459519123 (EA) 40198459519124 (CS), Lot Number 25LMA999;  Medline Kit SKU DYNJT3266:  UDI/DI 10198459320965 (EA) 40198459320966 (CS), Lot Number 25KMI561;  Medline Kit SKU DYNJT4178:  UDI/DI 10198459421020 (EA) 40198459421021 (CS), Lot Number 25KMB763;  Medline Kit SKU PHS41728D:  UDI/DI 10198459438691 (EA) 40198459438692 (CS), Lot Number 25JBW576;  Medline Kit SKU SPEC0156A:  UDI/DI 10888277239012 (EA) 40888277239013 (CS), Lot Number 25JBW895.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2026%22", "url": "https://recallledger.net/recalls/device-z-1193-2026-medline-medical-procedure-convenience-kits-labeled-as-1-drawer-1/"}, {"id": "fda-device-z-1192-2026", "source": "FDA", "category": "device", "recall_number": "Z-1192-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tMEM MAXILLOFACIAL PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tMEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R;   2)\tPLASTICS VCH, Kit SKU DYNJ39225K;   3)\tWT BREAST PACK, Kit SKU DYNJ46620I;   4)\tENDO / AUG PACK, Kit SKU DYNJ59250I;   5)\tKMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J;   6)\tPLASTICS PACK, Kit SKU DYNJ68288A;   7)\tIMPLANT REMOVAL KIT, Kit SKU MNS13035;   8)\tPLASTICS PACK-LF, Kit SKU PHS41746D.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "66 units", "codes": "Medline Kit SKU DYNJ0660040R:  UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Number 25KMG652;  Medline Kit SKU DYNJ39225K:  UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25JMJ958;  Medline Kit SKU DYNJ39225K:  UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25KMJ566;  Medline Kit SKU DYNJ46620I:  UDI/DI 10198459404009 (EA) 40198459404000 (CS), Lot Number 25KBE927;  Medline Kit SKU DYNJ59250I:  UDI/DI 10198459359941 (EA) 40198459359942 (CS), Lot Number 25KMB767;  Medline Kit SKU DYNJ65980J:  UDI/DI 10198459423727 (EA) 40198459423728 (CS), Lot Number 25KMJ630;  Medline Kit SKU DYNJ68288A:  UDI/DI 10195327056995 (EA) 40195327056996 (CS), Lot Number 25KMF183;  Medline Kit SKU MNS13035:  UDI/DI 10653160990482 (EA) 40653160990483 (CS), Lot Number 25KME754;  Medline Kit SKU PHS41746D:  UDI/DI 10198459438820 (EA) 40198459438821 (CS), Lot Number 25KMD226.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1192-2026%22", "url": "https://recallledger.net/recalls/device-z-1192-2026-medline-medical-procedure-convenience-kits-labeled-as-1-mem-maxil/"}, {"id": "fda-device-z-1191-2026", "source": "FDA", "category": "device", "recall_number": "Z-1191-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tSMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P;   2)\tDEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K;   3)\tLAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J;   4)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N;   5)\tSMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O;   6)\tBWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B;   7)\tMINOR SET UP PACK, Kit SKU DYNJ43272K;   8)\tPK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C;   9)\tGV LAP CHOLE PACK, Kit SKU DYNJ46939Q;   10)\tLAP CHOLE PACK, Kit SKU DYNJ49688C;   11)\tGENERAL ROBOTIC LAP, Kit SKU DYNJ51347N;   12)\tLAP CHOLE PACK, Kit SKU DYNJ54081F;   13)\tPEDIATRIC MOSES, Kit SKU DYNJ58864B;   14)\tLAPAROTOMY PACK, Kit SKU DYNJ59313B;   15)\tCRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F;   16)\tLAP GASTRIC PACK, Kit SKU DYNJ62065A;   17)\tMINOR PACK, Kit SKU DYNJ64174A;   18)\tGENERAL SURGERY PACK, Kit SKU DYNJ64258I;   19)\tGENERAL LAP SHARED-LF, Kit SKU DYNJ64786D;   20)\tCHOLE PACK, Kit SKU DYNJ67686B;   21)\tGEN SURG MINOR PACK, Kit SKU DYNJ69142F;   22)\tLAP CHOLE PACK, Kit SKU DYNJ81695B;   23)\tGENERAL LAPAROSCOPY, Kit SKU DYNJ900901K;   24)\tGEN MINOR, Kit SKU DYNJ900906L;   25)\tROBOTIC GENERAL, Kit SKU DYNJ906861D;   26)\tRMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C;   27)\tLAP CHOLE LMC CDS, Kit SKU DYNJ911116A;   28)\tMINOR GENERAL PACK, Kit SKU DYNJT3884;   29)\tGENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504;   30)\tMINOR SURGERY PACK-LF, Kit SKU PHS109062D.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "456 units", "codes": "Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830;  Medline Kit SKU DYNJ19974P:  UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395;  Medline Kit SKU DYNJ20027K:  UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132;  Medline Kit SKU DYNJ20468J:  UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540;  Medline Kit SKU DYNJ25763N:  UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134;  Medline Kit SKU DYNJ25763O:  UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209;  Medline Kit SKU DYNJ32836B:  UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167;  Medline Kit SKU DYNJ43272K:  UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892;  Medline Kit SKU DYNJ43976C:  UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437;  Medline Kit SKU DYNJ46939Q:  UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059;  Medline Kit SKU DYNJ49688C:  UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180;  Medline Kit SKU DYNJ51347N:  UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506;  Medline Kit SKU DYNJ54081F:  UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295;  Medline Kit SKU DYNJ58864B:  UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678;  Medline Kit SKU DYNJ59313B:  UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736;  Medline Kit SKU DYNJ61095F:  UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402;  Medline Kit SKU DYNJ62065A:  UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773;  Medline Kit SKU DYNJ64174A:  UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281;  Medline Kit SKU DYNJ64258I:  UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665;  Medline Kit SKU DYNJ64786D:  UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978;  Medline Kit SKU DYNJ67686B:  UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683;  Medline Kit SKU DYNJ69142F:  UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891;  Medline Kit SKU DYNJ81695B:  UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850;  Medline Kit SKU DYNJ900901K:  UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907;  Medline Kit SKU DYNJ900906L:  UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386;  Medline Kit SKU DYNJ906861D:  UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703;  Medline Kit SKU DYNJ907087C:  UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214;  Medline Kit SKU DYNJ911116A:  UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766;  Medline Kit SKU DYNJT3884:  UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326;  Medline Kit SKU DYNJT4504:  UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188;  Medline Kit SKU PHS109062D:  UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2026%22", "url": "https://recallledger.net/recalls/device-z-1191-2026-medline-medical-procedure-convenience-kits-labeled-as-1-smj-lap-c/"}, {"id": "fda-device-z-1190-2026", "source": "FDA", "category": "device", "recall_number": "Z-1190-2026", "title": "Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1)\tMIDDLE EAR CDS, Kit SKU CDS984347O;   2)\tHEAD AND NECK CDS-LF, Kit SKU CDS984857N;   3)\tNECK PACK-LF, Kit SKU DYNJ0966130K;   4)\tNECKLINE PACK-LF, Kit SKU DYNJ51440B;   5)\tTHYROID PACK, Kit SKU DYNJ58742J;   6)\tENT I, Kit SKU DYNJ63781B;   7)\tNECK PACK, Kit SKU DYNJ82751B;   8)\tNOSE PACK, Kit SKU DYNJ82753C;   9)\tWMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "40 units", "codes": "Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733;  Medline Kit SKU CDS984347O:  UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147;  Medline Kit SKU CDS984857N:  UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220;  Medline Kit SKU DYNJ0966130K:  UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804;  Medline Kit SKU DYNJ51440B:  UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445;  Medline Kit SKU DYNJ58742J:  UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534;  Medline Kit SKU DYNJ63781B:  UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068;  Medline Kit SKU DYNJ82751B:  UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309;  Medline Kit SKU DYNJ82753C:  UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126;  Medline Kit SKU DYNJ907206G:  UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1190-2026%22", "url": "https://recallledger.net/recalls/device-z-1190-2026-medline-medical-procedure-convenience-kits-labeled-as-1-middle-ea/"}, {"id": "fda-device-z-1189-2026", "source": "FDA", "category": "device", "recall_number": "Z-1189-2026", "title": "Medline medical procedure convenience kits labeled as:    1) BREAST-HERNIA-PORT CDS-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L;   2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B;   3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU CDS984853L:  UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898;  Medline Kit SKU DYNJ45641B:  UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748;  Medline Kit SKU DYNJT3658A:  UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2026%22", "url": "https://recallledger.net/recalls/device-z-1189-2026-medline-medical-procedure-convenience-kits-labeled-as-1-breast-he/"}, {"id": "fda-device-z-1188-2026", "source": "FDA", "category": "device", "recall_number": "Z-1188-2026", "title": "Medline medical procedure convenience kits labeled as:    1) PACER / CATH LAB PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A;   2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L;   3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B;   4) PACEMAKER SET UP, Kit SKU DYNJ63377D;   5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D;   6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C;   7) SCC VEIN PACK, Kit SKU DYNJ69313;   8) CV PACK, Kit SKU DYNJ86007B.", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU DYNJ0972604A:  UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144;  Medline Kit SKU DYNJ33822L:  UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419;  Medline Kit SKU DYNJ45640B:  UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793;  Medline Kit SKU DYNJ63377D:  UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988;  Medline Kit SKU DYNJ65011D:  UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161;  Medline Kit SKU DYNJ69143C:  UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211;  Medline Kit SKU DYNJ69313:  UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489;  Medline Kit SKU DYNJ86007B:  UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1188-2026%22", "url": "https://recallledger.net/recalls/device-z-1188-2026-medline-medical-procedure-convenience-kits-labeled-as-1-pacer-c/"}, {"id": "fda-device-z-1187-2026", "source": "FDA", "category": "device", "recall_number": "Z-1187-2026", "title": "Medline medical procedure convenience kits labeled as:    1) CATH LAB PACEMAKER PACK-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C;   2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1,928 total", "codes": "Medline Kit SKU DYNJ64837C:  UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193;  Medline Kit SKU DYNJT7034:  UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1187-2026%22", "url": "https://recallledger.net/recalls/device-z-1187-2026-medline-medical-procedure-convenience-kits-labeled-as-1-cath-lab/"}, {"id": "fda-device-z-1186-2026", "source": "FDA", "category": "device", "recall_number": "Z-1186-2026", "title": "Medline medical procedure convenience kits labeled as:  NERVE BLOCK TRAY 2 recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:  NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713", "reason": "Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "0", "codes": "UDI/DI 10198459565861 (EA) 40198459565862 (CS), Lot number 25KMD285", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2026%22", "url": "https://recallledger.net/recalls/device-z-1186-2026-medline-medical-procedure-convenience-kits-labeled-as-nerve-block-tr/"}, {"id": "fda-device-z-1185-2026", "source": "FDA", "category": "device", "recall_number": "Z-1185-2026", "title": "Conductivity Standard Solution  Catalog/Model Numbers:  10001 recall (NIPRO Technical Services, Inc.)", "product": "Conductivity Standard Solution  Catalog/Model Numbers:  10001, 10011, 10021, 10032, 10040, 10040c, and 10041    Conductivity Standard Solutions are a secondary standard solution used for the  calibration of conductivity cells together with conductivity meters", "reason": "due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.", "hazard_level": "Class II", "company": "NIPRO Technical Services, Inc.", "company_location": "Mesa, AZ, United States", "date": "2025-12-12", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.", "states": ["AL", "AR", "AZ", "CA", "DE", "FL", "GA", "IL", "IN", "KS", "MI", "MO", "NC", "ND", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "TN", "TX", "UT", "VA", "WA"], "nationwide": true, "quantity": "499 units", "codes": "Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106  (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107  (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120  (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119  (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108  (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121  (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834  (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1185-2026%22", "url": "https://recallledger.net/recalls/device-z-1185-2026-conductivity-standard-solution-catalog-model-numbers-10001-10011/"}, {"id": "fda-device-z-1184-2026", "source": "FDA", "category": "device", "recall_number": "Z-1184-2026", "title": "PREGNANCY TEST  24CT recall (GOLD STAR DISTRIBUTION INC)", "product": "PREGNANCY TEST  24CT", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Minnesota.", "states": ["MN"], "nationwide": true, "quantity": "N/A", "codes": "UPC 048155920200", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1184-2026%22", "url": "https://recallledger.net/recalls/device-z-1184-2026-pregnancy-test-24ct/"}, {"id": "fda-device-z-1183-2026", "source": "FDA", "category": "device", "recall_number": "Z-1183-2026", "title": "Toothbrushes recall (GOLD STAR DISTRIBUTION INC)", "product": "Toothbrushes, labeled as:  ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Minnesota.", "states": ["MN"], "nationwide": true, "quantity": "UNKNOWN", "codes": "ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT, UPC 3014260786847;  COLGATE TOOTH BRUSH MED. 12CT, UPC 6001067007289;  ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct, UPC 808829106879;  ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct, UPC 808829106886.   All codes purchased from this firm", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1183-2026%22", "url": "https://recallledger.net/recalls/device-z-1183-2026-toothbrushes-labeled-as-oral-b-tooth-brush-shiny-clean-soft-12ct-c/"}, {"id": "fda-device-z-1182-2026", "source": "FDA", "category": "device", "recall_number": "Z-1182-2026", "title": "Feminine hygiene products recall (GOLD STAR DISTRIBUTION INC)", "product": "Feminine hygiene products, labeled as:  KOTEX FREEDOM MAXI NO WINGS 48CT,   ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS  36/10CT, STAY FREE  REG. 12/10CT, STAY FREE SUPER   24/6CT, TAMPAX  REG. 10CT, TAMPAX  SUPER  10CT.", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Minnesota.", "states": ["MN"], "nationwide": true, "quantity": "unknown", "codes": "KOTEX FREEDOM MAXI NO WINGS 48CT, UPC 8935107214222;  ALWAYS THIN LINERS UNSCENTED 12 CT, UPC 037000426882;  ALWAYS THIN LINERS SCENTED 12CT, UPC 037000426899;  ALWAYS ULT.THIN WINGS REG.12/22CT, UPC none;  ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, UPC none;   JULIE MAXI NIGHT W.WINGS  36/10CT, UPC 710865100653;  STAY FREE  REG. 12/10CT, UPC 078300070320;  STAY FREE SUPER   24/6CT, UPC 078300070245;  TAMPAX  REG. 10CT, UPC 073010214095;  TAMPAX  SUPER  10CT, UPC 073010314092.   All codes purchased from this firm", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1182-2026%22", "url": "https://recallledger.net/recalls/device-z-1182-2026-feminine-hygiene-products-labeled-as-kotex-freedom-maxi-no-wings-48/"}, {"id": "fda-device-z-1181-2026", "source": "FDA", "category": "device", "recall_number": "Z-1181-2026", "title": "Condoms recall (GOLD STAR DISTRIBUTION INC)", "product": "Condoms, labeled as:  TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS  6/DSP DARK BLUE,   TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS  MAGNUM  48 CT DISP, *BOX TROJAN CONDOMS MAGNUM  50CT\t.", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Minnesota.", "states": ["MN"], "nationwide": true, "quantity": "unknown", "codes": "TROJAN MAGNUM CONDOMS 6/DSP BLACK, UPC 022600642039;  TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, UPC 022600930501;  TROJAN SPERMICIDE CONDOMS  6/DSP DARK BLUE, UPC 022600931508;  TROJAN ULTRA THIN CONDOMS 6/DSP GREY, UPC 022600926207;  TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, UPC 022600940500;  TROJAN NONLUBRICATED CONDOMS 6/DSP RED, UPC 22600920502;  TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, UPC 022600973201;  TROJAN CONDOMS  MAGNUM  48 CT DISP, UPC 815556020125;  *BOX TROJAN CONDOMS MAGNUM  50Ct, UPC none All codes purchased from this firm", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1181-2026%22", "url": "https://recallledger.net/recalls/device-z-1181-2026-condoms-labeled-as-trojan-magnum-condoms-6-dsp-black-trojan-lubric/"}, {"id": "fda-device-z-1180-2026", "source": "FDA", "category": "device", "recall_number": "Z-1180-2026", "title": "Bandages and first aid kits:  FIRST AID KIT 24/42PC recall (GOLD STAR DISTRIBUTION INC)", "product": "Bandages and first aid kits:  FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of Minnesota.", "states": ["MN"], "nationwide": true, "quantity": "unknown", "codes": "FIRST AID KIT 24/42PC, UPC 808829102536;  LUCKY FIRST AID BANDAGES 24CT, UPC 808829041002. All codes purchased from this firm", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1180-2026%22", "url": "https://recallledger.net/recalls/device-z-1180-2026-bandages-and-first-aid-kits-first-aid-kit-24-42pc-lucky-first-aid-b/"}, {"id": "fda-device-z-1179-2026", "source": "FDA", "category": "device", "recall_number": "Z-1179-2026", "title": "Alphenix INFX-8000V recall (Canon Medical System, USA, INC.)", "product": "Alphenix INFX-8000V, interventional fluoroscopic x-ray system", "reason": "It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional   systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2025-12-19", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Dominican Republic.", "states": [], "nationwide": true, "quantity": "332 units", "codes": "serial numbers:  B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263, A2A2262450, A2A22Z2576, W4A1252250, A2A20Z2167, W4A10X2001, A2A2412831, W1C0552181, W1D0842501, W4D13Z2452, W4A1322350, W4D1422467, B2A1472002, A1C1982123, W2A1062134, W1B08X2042, W2A1072139, W4A1242220, A2A2382741, B2A17Z2627, A2A2152264, W4C1362387, W4D1422465, D4W1262257, W1D0892543, W4D1462478, W4A1182118, W4A11X2133, W4A11Z2167, N/A Deinstalled, A1B18Z7003, W4A1252243, DFP800A-0001, A3552017, W2A1092165, W1D0882537, A2A2122203, W4A10Z2022, W4B1332361, A2A23Y2788, W4A12Z2328, B2A1662374, W4A12Z2329, B2A1622309, B2A14X2056, A2A2272459, A2A2172291, W4A1132061, W1D0832488, W1D0882536, W2A0962022, W2A0982038, W2A0972026, B2A1642351, A2A2152255, W1D0752392, A2A2182308, A2A2412836, A2A2112189, A2A21X2336, A1C19Y2164, A1C1942056, A2A2192328, A2A2332643, W4C1372398, A2A22Y2553, A2A2132226, W4A1262256, B2A1472013, W2A1022097, W2A1022094, W4A10Z2017, W1B08Y2055, B2A1492051, B2A1492052, W4A10Z2021, W4A12Z2332, W4D1412463, W4A1122040, B2B1862727, B2B1812651, B2A1662376, B2A16X2448, B2A1742547, W4A1242230, W4A1272271, G3514035, B2A17X2601, W1D07Z2454, W4A1272272, A2A2142238, B2B1862746, B2B18X2800, A2A2022014, A2A2032029, A2A2172288, A2A2122199, A2A2152258, A2A2012004, W4A10X2004, B2B18X2810, B2B1952847, A2A2142244, A2A2172297, W2A0992045, W4A1262253, W4A1282278, W4A12Z2330, W4A1312340, W2A09Z2075, B2A1652363, W4A1272266, W4A1162079, A2A2152253, W2A1092160, W4D1452476, W1D07Y2445, W2A1072147, A1C1962090, A1C1962089, B2A1652362, W4D14Y2481, A2A20Z2157, A2A22Y2547, A2A2162266, W4A1212183, W4A1212189, W4A1212190, W4A11Z2172, W4A1212178, W4A1212191, W4A1212185, W4A1212184, W4A1132060, W4A1242222, B2A1612295, B2A16Y2468, W4A1222003, A4512077, W2A0982043, W1D0892547, W2A0972030, W2A1042109, A2A2322602, W2A1047001, A1C1982121, A2A2332647, B2A16Y2455, B2A16Y2456, B2A17X2608, B2A17X2605, B2A17X2607, B2A1592231, A2A2232398, B2B1822666, W1B08Z2064, W1B08Z2067, A1C1942063, A1B1922042, B2B1842698, B2B1882777, B2B1892792, W4A1162083, A1C1962094, W4A1222202, W4A12X2299, B2A15X2243, A2A20Y2153, W2A1072141, W4A10Z2014, W4A1142064, W4A1252239, W2A1062136, A2A21X2344, W1D0697017, A2A2022026, A2A22Z2572, W1D0882538, A2A2142237, A2A20Z2161, A1C1992148, W4A1252241, B2A16X2454, W4A1242223, W4A1162089, A2A2242410, B2A1622320, W1D0812470, A2A2182307, A2A2332638, W4A1272240, B2A16Y2474, A2A2262444, A1C1952074, B2A1612300, W4A10Y2006, B2A1582203, W4A1242231, W4A12X2300, B2A1522121, B2A1532152, A2A2142245, B2A1512107, W4D1452473, A1C1992135, A2A2132229, A2A2092109, A2A2052055, A2A2142241, W2A09Y2065, A2A2062064, A2A21X2347, W4C1382414, B2A16Z2492, B2B1582210, B2A14X2062, B2A14Z2097, B2B1882769, W2A0962024, W4A1272261, W2A1052126, W2A09Y2064, B2A1622321, W4A10Z2018, W4A1262254, W4A1182121, W4C13X2433, W4C13X2432, W4C1372401, W1C0632285, A2A2282476, W4C1362389, W4A1322353, B2A15Y2252, W2A1042114, W2A1052125, W2A1072142, W4A1312343, W4A1142063, W4C1362388, W4C1352376, W4C1352378, B2B1862733, A1C1962097, B2B2032825, B2A1592224, A1C1962088, W1B08X2026, W1D0872529, W1D0732379, B2B1872763, B2A17Z2630, B2A17Z2629, W4A11X2132, W4A1112033, F1514114, W4A1122043, W4A1242237, W1D0697015, W1B08X2036, A2A2132227, W1B08Y2050, W4A1112035, W2A09Z2078, A2A2292515, A2A2422852, B2A1582215, W4A1272262, A1C1942064, W4C1342371, A1C19X2155, W4A1212186, W4A1212175, A2A2072088, B2A16Y2467, B2A1612293, B2B18Z2830, B2B1812654, W4A11Z2169, W4A1222196, W4A1212174, W1D0862519, W4A1217002, W4A1242225, B2A14X2057, A2A2432873, W1D0892545, A2A2232396, A2A2382740, W4D1452474, B2A17Z2634, B2B1842701, W2A1072145, F9624025, B2A1532147, A2A2262447, A2A2142246, B2A14Z2099, A2A2152262, B2B1832680, A2A2242429, W1D0782416, B2B1862728, B2B1862735, B2A1642352, B2A16Z2480, W4A1312344, A2A2082098, W2A0982041, B2A1772578, A2A2092106, W4A1162085, B2B1832692, A2A2142236, B2A1552177, A1B1932051, A1B1932049, B2A1682401, W4A12Z2323, B2A1712502, B2A17X2604, W4A12Y2316, B2A1712504, B2A1512106, A2A20X2083.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2026%22", "url": "https://recallledger.net/recalls/device-z-1179-2026-alphenix-infx-8000v-interventional-fluoroscopic-x-ray-system/"}, {"id": "fda-device-z-1178-2026", "source": "FDA", "category": "device", "recall_number": "Z-1178-2026", "title": "Alphenix INFX-8000H recall (Canon Medical System, USA, INC.)", "product": "Alphenix INFX-8000H, interventional fluoroscopic x-ray system", "reason": "It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional   systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2025-12-19", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Dominican Republic.", "states": [], "nationwide": true, "quantity": "3 units", "codes": "serial numbers:  D2A1672385, A2A20Z2165, B2A1692426.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1178-2026%22", "url": "https://recallledger.net/recalls/device-z-1178-2026-alphenix-infx-8000h-interventional-fluoroscopic-x-ray-system/"}, {"id": "fda-device-z-1177-2026", "source": "FDA", "category": "device", "recall_number": "Z-1177-2026", "title": "Alphenix INFX-8000F recall (Canon Medical System, USA, INC.)", "product": "Alphenix INFX-8000F, interventional fluoroscopic x-ray system", "reason": "It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional   systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2025-12-19", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Dominican Republic.", "states": [], "nationwide": true, "quantity": "98 units", "codes": "serial numbers:  W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A2052056, A2A2062062, A2A2072075, A2A2042041, A1C19Z2181, W2A1092163, A2A2012005, A2A20Y2147, A1C19Y2161, B2A1612289, W4A1112030, W2A0982042, B2B18X2802, B2A1712503, B2A1712499, B2A14Z2084.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1177-2026%22", "url": "https://recallledger.net/recalls/device-z-1177-2026-alphenix-infx-8000f-interventional-fluoroscopic-x-ray-system/"}, {"id": "fda-device-z-1176-2026", "source": "FDA", "category": "device", "recall_number": "Z-1176-2026", "title": "Alphenix INFX-8000C recall (Canon Medical System, USA, INC.)", "product": "Alphenix INFX-8000C, interventional fluoroscopic x-ray system", "reason": "It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional   systems may become loose. 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All UDI Codes; All Lots.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1167-2026%22", "url": "https://recallledger.net/recalls/device-z-1167-2026-fixone-biocomposite-anchor/"}, {"id": "fda-device-z-1166-2026", "source": "FDA", "category": "device", "recall_number": "Z-1166-2026", "title": "Fixone Hybrid Anchor recall (Aju Pharm Co., Ltd.)", "product": "Fixone Hybrid Anchor", "reason": "Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.", "hazard_level": "Class II", "company": "Aju Pharm Co., Ltd.", "company_location": "Seongnam, N/A, Korea (the Republic of)", "date": "2025-12-17", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA & PR.", "states": ["CA", "PR"], "nationwide": true, "quantity": "233 units", "codes": "Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1166-2026%22", "url": "https://recallledger.net/recalls/device-z-1166-2026-fixone-hybrid-anchor/"}, {"id": "fda-device-z-1165-2026", "source": "FDA", "category": "device", "recall_number": "Z-1165-2026", "title": "PearMatrix P-15 Peptide Enhanced Bone Graft  Bone Graft recall (Cerapedics, Inc.)", "product": "PearMatrix P-15 Peptide Enhanced Bone Graft  Bone Graft, 1.0cc  REF: 730-010", "reason": "Incorrect expiration date", "hazard_level": "Class II", "company": "Cerapedics, Inc.", "company_location": "Westminster, CO, United States", "date": "2025-12-29", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, CO, CT, FL, GA, ID, IL, KS, LA, MI, MN, MO, MT, NE, NJ, NV,  NY, OH,OR, PA, TN, TX, WA, WY.", "states": ["CA", "CO", "CT", "FL", "GA", "ID", "IL", "KS", "LA", "MI", "MN", "MO", "MT", "NE", "NJ", "NV", "NY", "OH", "OR", "PA", "TN", "TX", "WA", "WY"], "nationwide": true, "quantity": "237 units", "codes": "Lot: 7014819/UDI: (01)00850001680196", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1165-2026%22", "url": "https://recallledger.net/recalls/device-z-1165-2026-pearmatrix-p-15-peptide-enhanced-bone-graft-bone-graft-1-0cc-ref-7/"}, {"id": "fda-device-z-1164-2026", "source": "FDA", "category": "device", "recall_number": "Z-1164-2026", "title": "Brand Name: Elekta Medical Linear Accelerator  Product Name: Elekta Synergy recall (Elekta, Inc.)", "product": "Brand Name: Elekta Medical Linear Accelerator  Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD  Software Version: N/A  Product Description: Digital Linear Accelerator  Component: No", "reason": "Due to a manufacturing issue and electrical grounding of systems.", "hazard_level": "Class II", "company": "Elekta, Inc.", "company_location": "Atlanta, GA, United States", "date": "2025-12-14", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide", "states": [], "nationwide": false, "quantity": "5391", "codes": "Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB)  05060191071543 (NFB) Elekta Infinity 05060191071512 (FB)  05060191071574 (NFB) Versa HD 05060191071529 (FB)  05060191071581  Harmony 05060191071604  Harmony Pro 07340201503461  Elekta Evo", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2026%22", "url": "https://recallledger.net/recalls/device-z-1164-2026-brand-name-elekta-medical-linear-accelerator-product-name-elekta-sy/"}, {"id": "fda-device-z-1117-2026", "source": "FDA", "category": "device", "recall_number": "Z-1117-2026", "title": "Brand Name: Broselow  Product Name: BROSELOW\" FILLED BROSELOW ORGANIZER  Model/Catalog... recall (SunMed Holdings, LLC)", "product": "Brand Name: Broselow  Product Name: BROSELOW\" FILLED BROSELOW ORGANIZER  Model/Catalog Number: 7730IALS  Software Version: Not Applicable  Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.  Component: no", "reason": "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.", "hazard_level": "Class I", "company": "SunMed Holdings, LLC", "company_location": "Grand Rapids, MI, United States", "date": "2025-12-15", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.", "states": [], "nationwide": true, "quantity": "89", "codes": "Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593   UDI-DI Each-10889483589205 Case-30889483589209", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1117-2026%22", "url": "https://recallledger.net/recalls/device-z-1117-2026-brand-name-broselow-product-name-broselow-filled-broselow-organize/"}, {"id": "fda-device-z-1116-2026", "source": "FDA", "category": "device", "recall_number": "Z-1116-2026", "title": "Brand Name: Broselow  Product Name: Broselow Domestic Complete ALS Organizer ... recall (SunMed Holdings, LLC)", "product": "Brand Name: Broselow  Product Name: Broselow Domestic Complete ALS Organizer  Model/Catalog Number: 7730ALS  Software Version: Not Applicable  Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.  Component: No", "reason": "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.", "hazard_level": "Class I", "company": "SunMed Holdings, LLC", "company_location": "Grand Rapids, MI, United States", "date": "2025-12-15", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.", "states": [], "nationwide": true, "quantity": "384", "codes": "Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110   UDI-DI Each-10889483589151", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1116-2026%22", "url": "https://recallledger.net/recalls/device-z-1116-2026-brand-name-broselow-product-name-broselow-domestic-complete-als-org/"}, {"id": "fda-device-z-1115-2026", "source": "FDA", "category": "device", "recall_number": "Z-1115-2026", "title": "Brand Name: Broselow  Product Name: Broselow Pediatric Emergency Rainbow Tape ... recall (SunMed Holdings, LLC)", "product": "Brand Name: Broselow  Product Name: Broselow Pediatric Emergency Rainbow Tape  Model/Catalog Number: 7700RE  Software Version: Not Applicable  Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.  Component: No", "reason": "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.", "hazard_level": "Class I", "company": "SunMed Holdings, LLC", "company_location": "Grand Rapids, MI, United States", "date": "2025-12-15", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.", "states": [], "nationwide": true, "quantity": "20583", "codes": "Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824  UDI-DI Each-10889483588963 Case-30889483588967", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1115-2026%22", "url": "https://recallledger.net/recalls/device-z-1115-2026-brand-name-broselow-product-name-broselow-pediatric-emergency-rainb/"}, {"id": "fda-device-z-1114-2026", "source": "FDA", "category": "device", "recall_number": "Z-1114-2026", "title": "Brand Name: Broselow  Product Name: Broselow Pediatric Emergency Rainbow Tape ... recall (SunMed Holdings, LLC)", "product": "Brand Name: Broselow  Product Name: Broselow Pediatric Emergency Rainbow Tape  Model/Catalog Number: 7700REA  Software Version: Not Applicable  Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.  Component: No", "reason": "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.", "hazard_level": "Class I", "company": "SunMed Holdings, LLC", "company_location": "Grand Rapids, MI, United States", "date": "2025-12-15", "report_date": "2026-02-04", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.", "states": [], "nationwide": true, "quantity": "95300", "codes": "Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717  UDI-DI Each-10889483588970 Case-30889483588974", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2026%22", "url": "https://recallledger.net/recalls/device-z-1114-2026-brand-name-broselow-product-name-broselow-pediatric-emergency-rainb/"}, {"id": "fda-food-h-0458-2026", "source": "FDA", "category": "food", "recall_number": "H-0458-2026", "title": "Cuban Crackers Galletas Cubanas recall (Lily's Bakery Factory)", "product": "Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060", "reason": "Undeclared colors FD&C yellow #5, FD&C yellow #6, and FD&C red 40", "hazard_level": "Class II", "company": "Lily's Bakery Factory", "company_location": "Clewiston, FL, United States", "date": "2025-12-02", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product was only distributed in Florida.", "states": ["FL"], "nationwide": false, "quantity": "890 boxes", "codes": "Expiration 05/01/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0458-2026%22", "url": "https://recallledger.net/recalls/food-h-0458-2026-cuban-crackers-galletas-cubanas-net-wt-8oz-226g-distributed-by-bes/"}, {"id": "fda-food-h-0457-2026", "source": "FDA", "category": "food", "recall_number": "H-0457-2026", "title": "MEAL SIMPLE RED LENTIL DAL SOUP recall (Bakkavor)", "product": "MEAL SIMPLE RED LENTIL DAL SOUP NET WT. 16 OZ (1 LB) 454g UPC 1 97870 07333 0 MADE WITH PRIDE AND CARE FOR H-E-B-, SAN ANTONIO, TEXAS 78204", "reason": "Undeclared Milk.  Wrong product in container.", "hazard_level": "Class II", "company": "Bakkavor", "company_location": "Charlotte, NC, United States", "date": "2025-12-08", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "All product was shipped to one distribution center in TX.", "states": ["TX"], "nationwide": false, "quantity": "291cs/6/1lb cups", "codes": "Lot: 882428 Best By Date 1/11/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0457-2026%22", "url": "https://recallledger.net/recalls/food-h-0457-2026-meal-simple-red-lentil-dal-soup-net-wt-16-oz-1-lb-454g-upc-1-97870/"}, {"id": "fda-food-h-0416-2026", "source": "FDA", "category": "food", "recall_number": "H-0416-2026", "title": "White Castle Original Sliders recall (White Castle System)", "product": "White Castle Original Sliders, Net Wt. 6.35 oz. (180g), packaged as a 4-count carton, each containing 2-Two Packs. UPC 082988029693, packed 6 cartons per case.", "reason": "Undeclared allergens (milk and soy).", "hazard_level": "Class I", "company": "White Castle System", "company_location": "Columbus, OH, United States", "date": "2025-12-10", "report_date": "2026-01-28", "status": "Terminated", "distribution": "IL, OH, TX", "states": ["IL", "OH", "TX"], "nationwide": false, "quantity": "1,021 cases", "codes": "Lot Codes: 9H203521, 9H203522 Best By: 18APR2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0416-2026%22", "url": "https://recallledger.net/recalls/food-h-0416-2026-white-castle-original-sliders-net-wt-6-35-oz-180g-packaged-as-a/"}, {"id": "fda-food-h-0415-2026", "source": "FDA", "category": "food", "recall_number": "H-0415-2026", "title": "Mini Gaceniga Authentic Cuban Loaf Cake Classic recall (CATAO MARKET LLC)", "product": "Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.", "reason": "Undeclared colors FD&C Yellow #5", "hazard_level": "Class II", "company": "CATAO MARKET LLC", "company_location": "Miami, FL, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product distributed only in FL.", "states": ["FL"], "nationwide": false, "quantity": "385 master cases", "codes": "Product identified by Best By dates (12/18/2025 through 03/18/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0415-2026%22", "url": "https://recallledger.net/recalls/food-h-0415-2026-mini-gaceniga-authentic-cuban-loaf-cake-classic-net-wt-12-oz-340g/"}, {"id": "fda-food-h-0414-2026", "source": "FDA", "category": "food", "recall_number": "H-0414-2026", "title": "Mini Gaceniga Authentic Cuban Loaf Cake Raisins recall (CATAO MARKET LLC)", "product": "Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.", "reason": "Undeclared colors FD&C Yellow #5", "hazard_level": "Class II", "company": "CATAO MARKET LLC", "company_location": "Miami, FL, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product distributed only in FL.", "states": ["FL"], "nationwide": false, "quantity": "260 master cases (3,120 loaf cakes)", "codes": "Product identified by Best By dates (12/18/2025 through 03/18/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0414-2026%22", "url": "https://recallledger.net/recalls/food-h-0414-2026-mini-gaceniga-authentic-cuban-loaf-cake-raisins-net-wt-12-oz-340g/"}, {"id": "fda-food-h-0413-2026", "source": "FDA", "category": "food", "recall_number": "H-0413-2026", "title": "Gaceniga Authentic Cuban Loaf Cake Raisins recall (CATAO MARKET LLC)", "product": "Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.", "reason": "Undeclared colors FD&C Yellow #5", "hazard_level": "Class II", "company": "CATAO MARKET LLC", "company_location": "Miami, FL, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product distributed only in FL.", "states": ["FL"], "nationwide": false, "quantity": "520 master cases", "codes": "Product identified by Best By dates (12/18/2025 through 03/18/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0413-2026%22", "url": "https://recallledger.net/recalls/food-h-0413-2026-gaceniga-authentic-cuban-loaf-cake-raisins-net-wt-24-oz-680g-pack/"}, {"id": "fda-food-h-0412-2026", "source": "FDA", "category": "food", "recall_number": "H-0412-2026", "title": "Gacen¿iga Authentic Cuban Loaf Cake Classic recall (CATAO MARKET LLC)", "product": "Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.", "reason": "Undeclared colors FD&C Yellow #5", "hazard_level": "Class II", "company": "CATAO MARKET LLC", "company_location": "Miami, FL, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product distributed only in FL.", "states": ["FL"], "nationwide": false, "quantity": "775 master cases", "codes": "Product identified by Best By dates (12/18/2025 through 03/18/2026)", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0412-2026%22", "url": "https://recallledger.net/recalls/food-h-0412-2026-gaceniga-authentic-cuban-loaf-cake-classic-net-wt-24-oz-680g-pac/"}, {"id": "fda-food-h-0411-2026", "source": "FDA", "category": "food", "recall_number": "H-0411-2026", "title": "All human food products distributed from the firm.  Including but not limited to: ... recall (GOLD STAR DISTRIBUTION INC)", "product": "All human food products distributed from the firm.  Including but not limited to:  snack foods, candy, gum, cooking oil, canned fruit and beans, honey, Dietary supplements, peanut butter, oatmeal, rice, dry peas and beans, ramen, cold cereal, hot sauce, lemon juice, crackers, canned sardines tuna and Oyster, sauces, seasonings, sugar, bottled and canned beverages, coffee and filters and creamer, tea bags, canned pasta, dates, flour, baby food", "reason": "Potential exposure of rodents and rodent activity in the distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "IN, MN, ND", "states": ["IN", "MN", "ND"], "nationwide": false, "quantity": "unknown", "codes": "all codes of products purchased from this firm.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0411-2026%22", "url": "https://recallledger.net/recalls/food-h-0411-2026-all-human-food-products-distributed-from-the-firm-including-but-not/"}, {"id": "fda-food-h-0409-2026", "source": "FDA", "category": "food", "recall_number": "H-0409-2026", "title": "Gregory's Foods Bag Full of Cookies recall (Gregory's Foods, Inc)", "product": "Gregory's Foods Bag Full of Cookies, White Chocolate Macadamia Nut, frozen cookie dough.  Net Wt 2 lbs 8.5 oz (1148g).   UPC 8 30825-00124 7.   Keep Frozen.  Gregory's Foods, Inc., 1301 Trapp Road, Eagan, MN  55121.", "reason": "Undeclared peanuts.", "hazard_level": "Class I", "company": "Gregory's Foods, Inc", "company_location": "Eagan, MN, United States", "date": "2025-12-19", "report_date": "2026-01-28", "status": "Terminated", "distribution": "MN, ND, NE, WI", "states": ["MN", "ND", "NE", "WI"], "nationwide": false, "quantity": "308 cases (6 bags per case)", "codes": "Lot # 120625190 Best By 12/6/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0409-2026%22", "url": "https://recallledger.net/recalls/food-h-0409-2026-gregory-s-foods-bag-full-of-cookies-white-chocolate-macadamia-nut-fr/"}, {"id": "fda-food-h-0406-2026", "source": "FDA", "category": "food", "recall_number": "H-0406-2026", "title": "Australian Greenlip Abalone recall (Southern Rocklobster LTD USA)", "product": "Australian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC:  9335533013342", "reason": "Potential Listeria Monocytogenes contamination", "hazard_level": "Class II", "company": "Southern Rocklobster LTD USA", "company_location": "Vernon, CA, United States", "date": "2025-12-24", "report_date": "2026-01-28", "status": "Terminated", "distribution": "Product was distributed to one customer in multiple locations throughout California.", "states": ["CA"], "nationwide": false, "quantity": "94 cases", "codes": "Lot# 5996 Best Before: 29/11/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0406-2026%22", "url": "https://recallledger.net/recalls/food-h-0406-2026-australian-greenlip-abalone-frozen-9-pieces-net-wt-23-5-oz-upc-9/"}, {"id": "fda-drug-d-0295-2026", "source": "FDA", "category": "drug", "recall_number": "D-0295-2026", "title": "Icosapent Ethyl capsules recall (Zydus Pharmaceuticals (USA) Inc)", "product": "Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07", "reason": "Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules", "hazard_level": "Class II", "company": "Zydus Pharmaceuticals (USA) Inc", "company_location": "Pennington, NJ, United States", "date": "2025-12-30", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "22,896 bottles", "codes": "Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0295-2026%22", "url": "https://recallledger.net/recalls/drug-d-0295-2026-icosapent-ethyl-capsules-1-gram-120-count-bottles-rx-only-manufact/"}, {"id": "fda-drug-d-0291-2026", "source": "FDA", "category": "drug", "recall_number": "D-0291-2026", "title": "Diclofenac Sodium Topical Gel recall (Cipla USA, Inc.)", "product": "Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215.  NDC: 76282-103-39", "reason": "Failed PH Specifications", "hazard_level": "Class III", "company": "Cipla USA, Inc.", "company_location": "Warren, NJ, United States", "date": "2025-12-22", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "92,376 tubes", "codes": "Batch XHBG; Exp. 08/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0291-2026%22", "url": "https://recallledger.net/recalls/drug-d-0291-2026-diclofenac-sodium-topical-gel-1-net-wt-100-g-3-53-oz-manufacture/"}, {"id": "fda-device-z-1156-2026", "source": "FDA", "category": "device", "recall_number": "Z-1156-2026", "title": "Patient Information Center iX recall (Philips North America)", "product": "Patient Information Center iX;  Software Version Number: 4.5.0", "reason": "A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.", "hazard_level": "Class II", "company": "Philips North America", "company_location": "Cambridge, MA, United States", "date": "2025-12-22", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.", "states": [], "nationwide": true, "quantity": "146 units (41 US, 105 OUS)", "codes": "Model Numbers: (1) 866389, (2) 866390; UDI-DI: (1) 00884838127074, (2) N/A; Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E, 0F2U-1BLC-H, 291E-7HJU-A, 1M6W-1UP5-1, 4620-0XNW-5, 4W5R-3FHA-L, 6B73-3ZKP-K, 3E79-49M4-3, 4F6Y-70HU-P, 0128-2WG5-0, 0830-3RLW-W, 097K-7LPC-5, 0D2V-1BLC-8, 120T-17M9-A, 173C-20JM-J, 190B-64MU-U, 1K2J-15LB-P, 1L3T-7KGB-E, 2K06-4ZPR-X, 3916-5DJ6-Z, 3V7H-06MT-E, 412A-2WG5-Y, 4271-2NL7-M, 4Z3L-5PP3-0, 5D0E-3EH3-3, 5E0B-3EH3-D, 5E25-14LG-9, 657X-31N5-L, 6G5U-3FHA-R, 781T-7TJA-B, 7N3U-51MJ-B, 7P31-7NPM-P, 283X-7ZPB-A, 7H77-09GU-Z, 4C59-26K6-P, 4N0L-0FKE-2, 5Y0A-02P6-L, 494H-1CJJ-3, 326G-7PGV-A, 292G-3YNZ-9, 0V2A-6DHP-0, 6354-58M8-C, 4W5B-6JK9-A, 5M7K-0VKT-T, 3401-1FHE-M, 6R30-5BNT-N, 6N2E-7YK1-1, 6R0H-6AMX-T, 107C-62PF-Y, 2X1T-7TJA-H, 1M6G-7PGV-K, 1C4Z-6KKD-H, 0B3Z-2RHR-L, 7H39-3JGK-U, 0M0V-6FKB-5, 793D-41PZ-X, 233G-46MR-V, 782Z-3RLW-D, 5N2B-5YJP-G, 0L5F-0ZNF-J, 4G4N-2LKY-K, 2M48-4XM7-Y, 133W-3UN7-B, 295N-0YG8-Y, 5D7W-00G0-1, 5R78-6CPV-0, 3C79-49M4-9, 3T24-5CKL-A, 6H74-27LY-T, 186W-1UP5-8, 0021-1DNN-P, 0247-7ELE-R, 0D5Y-32PN-A, 0J7W-31N5-2, 0R2W-1VNP-P, 0Y5Z-7FHX-N, 121L-1KG1-M, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 1C19-1MHK-F, 1G0F-69LP-G, 1J5U-5HMV-N, 1P4F-34MB-W, 1P5C-6JK9-D, 212R-6HHJ-P, 221V-7TJA-4, 227N-7JG6-J, 232W-7DL9-G, 2A5X-2PJT-0, 2A75-27LY-3, 2F5J-0JLM-7, 2J19-1MHK-W, 2L16-59N8-M, 2M73-5WKF-U, 2N3V-6YM2-X, 2P6J-7PGV-E, 2Y5M-5AGH-E, 326W-21KC-B, 332M-47P7-Y, 3A29-0CKW-3, 3C0U-7AHH-6, 3C2U-05HF-W, 3E05-4ZPR-U, 3G6H-39G4-Y, 3H1T-22HW-5, 3H5R-5HMV-M, 3H79-09GU-5, 3J2K-2TP9-1, 3W1Y-3CH6-J, 4L7Y-00G0-F, 4M77-1HM0-G, 4N3D-20JM-K, 4R0G-60JV-1, 4V2Z-7NPM-M, 4W08-0UH7-U, 4X6C-1PJ5-J, 4Y08-0UH7-L, 500W-6WNX-A, 594D-0EG2-9, 5U0A-3WPK-C, 5W1G-50P2-N, 5Z6J-3HL1-B, 617W-31N5-F, 637V-7BG9-W, 673T-67ME-B, 686N-3NNV-6, 6D3P-4WMG-A, 6K70-3XNY-W, 6P42-35J4-V, 6U1T-75JN-Y, 771A-2JPY-0, 7F5L-73HZ-3, 7G3A-13JG-L, 7K0P-4AH2-6, 7Z2R-05HF-X, 1J1P-6PKN-T, 4R7H-7LPC-J, 282N-0WPA-X, 5G35-04K8-E, 366L-2XHV-A, 5L7D-2UGW-T, 4N0L-0FKE-2;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1156-2026%22", "url": "https://recallledger.net/recalls/device-z-1156-2026-patient-information-center-ix-software-version-number-4-5-0/"}, {"id": "fda-device-z-1139-2026", "source": "FDA", "category": "device", "recall_number": "Z-1139-2026", "title": "Rifton Equipment recall (Community Products, LLC)", "product": "Rifton Equipment, E-Pacer. Model/Catalog Number: K660.     The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.", "reason": "Potential for fraying on the body support strap.", "hazard_level": "Class II", "company": "Community Products, LLC", "company_location": "Rifton, NY, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.", "states": [], "nationwide": true, "quantity": "470 units", "codes": "Model/Catalog Number: K660. ID Codes: K66020170425AA, K66020170612AA, K66020170621AA, K66020170622AA, K66020170626AA, K66020170626AB, K66020170626AC, K66020170627AC, K66020170627AD, K66020170628AA, K66020170629AA, K66020170703AA, K66020170705AA, K66020170711AA, K66020170712AA, K66020170712AC, K66020170713AB, K66020170716AA, K66020170717AA, K66020170717AB, K66020170804AA, K66020170805AA, K66020170807AA, K66020170810AA, K66020170810AB, K66020170811AA, K66020170811AC, K66020170815AA, K66020170817AC, K66020170818AC, K66020170831AA, K66020170831AB, K66020170906AA, K66020170906AB, K66020170911AA, K66020170911AB, K66020170911AC, K66020170913AA, K66020170914AA, K66020170915AA, K66020170921AA, K66020170923AA, K66020170926AA, K66020170927AA, K66020170928AA, K66020171004AA, K66020171006AA, K66020171006AB, K66020171007AA, K66020171010AA, K66020171010AB, K66020171019AA, K66020171020AA, K66020171024AA, K66020171026AA, K66020171026AB, K66020171026AC, K66020171028AA, K66020171030AA, K66020171101AA, K66020171101AB, 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{"id": "fda-device-z-1138-2026", "source": "FDA", "category": "device", "recall_number": "Z-1138-2026", "title": "Rifton Equipment recall (Community Products, LLC)", "product": "Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320.    The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.", "reason": "Potential for fraying on the body support strap.", "hazard_level": "Class II", "company": "Community Products, LLC", "company_location": "Rifton, NY, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.", "states": [], "nationwide": true, "quantity": "1,096 units", "codes": "Model/Catalog Number: K320. 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"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1138-2026%22", "url": "https://recallledger.net/recalls/device-z-1138-2026-rifton-equipment-low-base-tram-model-catalog-number-k320-the-tr/"}, {"id": "fda-device-z-1137-2026", "source": "FDA", "category": "device", "recall_number": "Z-1137-2026", "title": "Rifton Equipment recall (Community Products, LLC)", "product": "Rifton Equipment, TRAM. Model/Catalog Number: K310.    The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.", "reason": "Potential for fraying on the body support strap.", "hazard_level": "Class II", "company": "Community Products, LLC", "company_location": "Rifton, NY, United States", "date": "2025-12-18", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of UAE, Australia, Canada, EU, Israel, Hong Kong, Japan, Korea, New Zealand, Russia, Saudi Arabia, and UK.", "states": [], "nationwide": true, "quantity": "3,238 units", "codes": "Model/Catalog Number: K310. 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K31020130425AF, K31020130425AG, K31020130425AH, K31020130425AI, K31020130425AJ, K31020130425AK, K31020130805AF, K31020131128AB, K31020141027AA, K31020141027AB, K31020141027AC, K31020141027AD, K31020141027AE, K31020141027AF, K31020150312AA, K31020171018AB, K31020171116AD, K31020171117AC, K31020171117AD, K31020171117AE, K31020180202AA, K31020190429AA, K31020200210AA, K31020200601AB, K31020200825AA, K31020201026AB, K31020201026AC, K31020201026AD, K31020160405AD, K31020160630AA, K31020170124AB, K31020170824AD, K31020190422AA, K31020190711AB, K31020200602AB, K31020190401AE, K31020200428AA, K31020200707AB.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1137-2026%22", "url": "https://recallledger.net/recalls/device-z-1137-2026-rifton-equipment-tram-model-catalog-number-k310-the-tram-is-a-p/"}, {"id": "fda-device-z-1136-2026", "source": "FDA", "category": "device", "recall_number": "Z-1136-2026", "title": "TS-10/TS-10H Tube Sorter recall (Sysmex America, Inc.)", "product": "TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17", "reason": "Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.", "hazard_level": "Class II", "company": "Sysmex America, Inc.", "company_location": "Lincolnshire, IL, United States", "date": "2025-12-15", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "44 units", "codes": "Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2026%22", "url": "https://recallledger.net/recalls/device-z-1136-2026-ts-10-ts-10h-tube-sorter-automatic-sorting-system-for-sorting-barcode/"}, {"id": "fda-device-z-1135-2026", "source": "FDA", "category": "device", "recall_number": "Z-1135-2026", "title": "The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique... recall (Beckman Coulter Ireland, Inc.)", "product": "The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product.    In phase two a second detergent in reagent 2 releases cholesterol from the LDL   lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.", "reason": "Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).", "hazard_level": "Class II", "company": "Beckman Coulter Ireland, Inc.", "company_location": "O'Callaghan'S Mills, Ireland", "date": "2025-12-08", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT, OK, NY, AZ, LA, OR, AL, MO, IN, IL, KY, MS, NH, AK, SD, MN, TN, PR, MI, IA, WI, WV, ME, SC, HI, RI, ND, NE, ID, AR, WY, DC, GU, DE, CT.  OUS: Brazil, South Africa, Argentina, Mexico, Canada, Costa Rica, Peru, El Salvador, Ecuador, Panama, Singapore, Ireland, United Kingdom of Great Britain and Northern Ireland, Germany, China, Korea, Republic of", "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", "WA", "WI", "WV", "WY"], "nationwide": false, "quantity": "34,451", "codes": "REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1135-2026%22", "url": "https://recallledger.net/recalls/device-z-1135-2026-the-ldl-cholesterol-assay-is-comprised-of-two-distinct-phases-in-phas/"}, {"id": "fda-device-z-1134-2026", "source": "FDA", "category": "device", "recall_number": "Z-1134-2026", "title": "Brand Name: Ion Endoluminal System  Product Name: Ion Vision Probe Bag  Model/Catalog... recall (Intuitive Surgical, Inc.)", "product": "Brand Name: Ion Endoluminal System  Product Name: Ion Vision Probe Bag  Model/Catalog Number: 490127  Software Version: N/A  Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures.     The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device.    The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times.    The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method.     Refer to HHE for additional details.  Component: N/A", "reason": "Due to probe bags that may have a compromised or incomplete sterile pouch seal.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.  O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom", "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": false, "quantity": "110580", "codes": "Lot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014  Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 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"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2026%22", "url": "https://recallledger.net/recalls/device-z-1134-2026-brand-name-ion-endoluminal-system-product-name-ion-vision-probe-bag/"}, {"id": "fda-device-z-1133-2026", "source": "FDA", "category": "device", "recall_number": "Z-1133-2026", "title": "Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE ... recall (MicroPort Orthopedics Inc.)", "product": "Brand Name: MicroPort  Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE  Model/Catalog Number: HTHT0036  Software Version: N/A  Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE", "reason": "Due to products not having FDA Premarket authorization to be distributed within the United States.", "hazard_level": "Class II", "company": "MicroPort Orthopedics Inc.", "company_location": "Arlington, TN, United States", "date": "2025-12-19", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida.  The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.", "states": ["CA", "CO", "FL", "GA", "IL", "KS", "MD", "MI", "MO", "TN", "TX", "WA", "WI"], "nationwide": false, "quantity": "91", "codes": "Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1133-2026%22", "url": "https://recallledger.net/recalls/device-z-1133-2026-brand-name-microport-product-name-hipturn-fem-head-trial-36mm-reusa/"}, {"id": "fda-device-z-1132-2026", "source": "FDA", "category": "device", "recall_number": "Z-1132-2026", "title": "Brand Name: VOLT\" Wrist Treatment System  Product Name: 2.4/2.7 2Column Dist Radius... recall (Tyber Medical)", "product": "Brand Name: VOLT\" Wrist Treatment System  Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm  Model/Catalog Number: 02.426.691S  Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm  Component: No", "reason": "The supplier manufactured anatomical left plates with an incorrect thread orientation.", "hazard_level": "Class II", "company": "Tyber Medical", "company_location": "Bethlehem, PA, United States", "date": "2025-12-19", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of PA.", "states": [], "nationwide": true, "quantity": "64 units", "codes": "Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1132-2026%22", "url": "https://recallledger.net/recalls/device-z-1132-2026-brand-name-volt-wrist-treatment-system-product-name-2-4-2-7-2colum/"}, {"id": "fda-device-z-1131-2026", "source": "FDA", "category": "device", "recall_number": "Z-1131-2026", "title": "Brand Name: VOLT\" Wrist Treatment System  Product Name: 2.4/2.7 2Column Dist Radius... recall (Tyber Medical)", "product": "Brand Name: VOLT\" Wrist Treatment System  Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm  Model/Catalog Number: 02.426.681S  Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm", "reason": "The supplier manufactured anatomical left plates with an incorrect thread orientation.", "hazard_level": "Class II", "company": "Tyber Medical", "company_location": "Bethlehem, PA, United States", "date": "2025-12-19", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of PA.", "states": [], "nationwide": true, "quantity": "100 units", "codes": "Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2026%22", "url": "https://recallledger.net/recalls/device-z-1131-2026-brand-name-volt-wrist-treatment-system-product-name-2-4-2-7-2colum/"}, {"id": "fda-device-z-1130-2026", "source": "FDA", "category": "device", "recall_number": "Z-1130-2026", "title": "Brand Name: LEASEIR  Product Name: LEASEIR MHR XCELL  Model/Catalog Number: MHR 110-b ... recall (LEASEIR TECHNOLOGIES SLU)", "product": "Brand Name: LEASEIR  Product Name: LEASEIR MHR XCELL  Model/Catalog Number: MHR 110-b  Software Version: 1.5.0.0  Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI).  The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue.  The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic).  The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes.  The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed.  Component: NO", "reason": "The console label for affected devices is missing the \"DANGER\" symbol.", "hazard_level": "Class II", "company": "LEASEIR TECHNOLOGIES SLU", "company_location": "Gijon, Spain", "date": "2025-12-15", "report_date": "2026-01-28", "status": "Completed", "distribution": "US Nationwide distribution in the states of Austin, Texas.", "states": ["TX"], "nationwide": true, "quantity": "2", "codes": "Lot Code: Device#1: Model: Leaseir MHR Xcell Serial Number: C10016, C10017 UDI-DI: 08437019546076", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1130-2026%22", "url": "https://recallledger.net/recalls/device-z-1130-2026-brand-name-leaseir-product-name-leaseir-mhr-xcell-model-catalog-nu/"}, {"id": "fda-device-z-1129-2026", "source": "FDA", "category": "device", "recall_number": "Z-1129-2026", "title": "Allwell Angioplasty Pack  REF: IS-30-B1/B recall (Merit Medical Systems, Inc.)", "product": "Allwell Angioplasty Pack  REF: IS-30-B1/B", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "328000 units", "codes": "UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1129-2026%22", "url": "https://recallledger.net/recalls/device-z-1129-2026-allwell-angioplasty-pack-ref-is-30-b1-b/"}, {"id": "fda-device-z-1128-2026", "source": "FDA", "category": "device", "recall_number": "Z-1128-2026", "title": "Merit Medical recall (Merit Medical Systems, Inc.)", "product": "Merit Medical , Custom Procedure Kit  Reference Numbers: K12T-04270A  K12T-07956   K12T-10922B", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "", "codes": "Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252  K12T-07956: UDI: 00884450264003/ Lot: K2618155   K2618156   K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2026%22", "url": "https://recallledger.net/recalls/device-z-1128-2026-merit-medical-custom-procedure-kit-reference-numbers-k12t-04270a/"}, {"id": "fda-device-z-1127-2026", "source": "FDA", "category": "device", "recall_number": "Z-1127-2026", "title": "Merit Medical recall (Merit Medical Systems, Inc.)", "product": "Merit Medical , Custom Manifold Kit  REF: K09-13203A", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "2192 units", "codes": "K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2026%22", "url": "https://recallledger.net/recalls/device-z-1127-2026-merit-medical-custom-manifold-kit-ref-k09-13203a/"}, {"id": "fda-device-z-1126-2026", "source": "FDA", "category": "device", "recall_number": "Z-1126-2026", "title": "Merit Medical recall (Merit Medical Systems, Inc.)", "product": "Merit Medical , Custom Inflation Kit  REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "18,897 units", "codes": "Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768  00884450294918 H2872045 K05-01717B: 00884450139325 H2613573  00884450139325 H2650871  00884450139325 H2697189  00884450139325 H2736533  00884450139325 H2767978  00884450139325 H2787955  00884450139325 H2823896  00884450139325 H2844892  00884450139325 H2849102  00884450139325 H2854783  00884450139325 H2864807  00884450139325 H2869821  00884450139325 H2911094  00884450139325 H2920493  00884450139325 H2937574  00884450139325 H2980776  00884450139325 H3006229  00884450139325 H3030118  00884450139325 H3041746  00884450139325 H3068295  00884450139325 H3077898  00884450139325 H3096168  00884450139325 H3115553  00884450139325 H3125118  00884450139325 H3136596  00884450139325 H3147935  00884450139325 H3179116  00884450139325 H3191157  00884450139325 H3215391  00884450139325 H3227692  00884450139325 H3266089  00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356  00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535  00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525  00884450286999 T2697344  00884450286999 T2730359  00884450286999 T2745227  00884450286999 T2779731  00884450286999 T2792255  00884450286999 T2805457  00884450286999 T2842259  00884450286999 T2865498  00884450286999 T2916415  00884450286999 T2981465  00884450286999 T2985902  00884450286999 T3039943  00884450286999 T3054879  00884450286999 T3071602  00884450286999 T3105835  00884450286999 T3128753  00884450286999 T3185484  00884450286999 T3223241  00884450286999 T3229633  00884450286999 T3276968  00884450286999 T3328128  00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647  00884450140796 T2800974  00884450140796 T2823388  00884450140796 T2853488  00884450140796 T2899143  00884450140796 T2981467  00884450140796 T2987762  00884450140796 T3022097  00884450140796 T3022100  00884450140796 T3058385  00884450140796 T3083003  00884450140796 T3121582  00884450140796 T3174127  00884450140796 T3214493  00884450140796 T3229456  00884450140796 T3297510  00884450140796 T3324542 K05T-01863: 00884450315347 T2625813  00884450315347 T2718633  00884450315347 T2762715  00884450315347 T2805459  00884450315347 T2823390  00884450315347 T2863782  00884450315347 T2910718  00884450315347 T2981470  00884450315347 T2997667  00884450315347 T3036044  00884450315347 T3070773  00884450315347 T3108821  00884450315347 T3149886S  00884450315347 T3185539  00884450315347 T3214494  00884450315347 T3216705  00884450315347 T3276914  00884450315347 T3296092  00884450315347 T3328139 K05T-01915: 00884450142882 T2643556  00884450142882 T2675575  00884450142882 T2752946  00884450142882 T2842262  00884450142882 T2893876  00884450142882 T2906056  00884450142882 T2981474  00884450142882 T2987764  00884450142882 T3070812  00884450142882 T3146178  00884450142882 T3216084  00884450142882 T3269009  00884450142882 T3322767  00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916  00884450260166 T3148674  00884450260166 T3204048  00884450260166 T3322760 K05T-01955: 00884450140826 T2643557  00884450140826 T2719601  00884450140826 T2765333  00884450140826 T2823391  00884450140826 T2861459  00884450140826 T2909930  00884450140826 T2945617  00884450140826 T2985905  00884450140826 T3070951  00884450140826 T3111451  00884450140826 T3190818  00884450140826 T3214495  00884450140826 T3278749  00884450140826 T3322843 K05T-02138: 00884450140833 T2716870  00884450140833 T2726918  00884450140833 T2745251  00884450140833 T2983353  00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335  00884450095607 T3271452  00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577  00884450684023 T2726919  00884450684023 T2759596  00884450684023 T2774653  00884450684023 T2800975  00884450684023 T2810448  00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522  00884450814710 T2898650  00884450814710 T2932783  00884450814710 T2985976  00884450814710 T2987768  00884450814710 T3043834  00884450814710 T3071604  00884450814710 T3105836  00884450814710 T3126557  00884450814710 T3185542  00884450814710 T3214496  00884450814710 T3229459  00884450814710 T3276962  00884450814710 T3309860  00884450814710 T3339469 K05T-02533: 00884450255803 T2718634  00884450255803 T2809725  00884450255803 T2849216  00884450255803 T2876922  00884450255803 T2899055  00884450255803 T2909932  00884450255803 T2981490  00884450255803 T3042476  00884450255803 T3071605  00884450255803 T3123415  00884450255803 T3181209  00884450255803 T3185434  00884450255803 T3293210  00884450255803 T3315474  00884450255803 T3336070 K05T-03153: 00884450463796 T2816275  00884450463796 T2850760  00884450463796 T2939991  00884450463796 T2985985  00884450463796 T3033317  00884450463796 T3202468 K05T-03201: 00884450547915 T2656028  00884450547915 T2690357  00884450547915 T2718635  00884450547915 T2823394  00884450547915 T2983258  00884450547915 T3044905  00884450547915 T3054900  00884450547915 T3113160  00884450547915 T3190819  00884450547915 T3216029  00884450547915 T3245297  00884450547915 T3328140", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1126-2026%22", "url": "https://recallledger.net/recalls/device-z-1126-2026-merit-medical-custom-inflation-kit-ref-k05-00761f-k05-01717b-k05-0/"}, {"id": "fda-device-z-1125-2026", "source": "FDA", "category": "device", "recall_number": "Z-1125-2026", "title": "Merit Medical recall (Merit Medical Systems, Inc.)", "product": "Merit Medical , Custom Waste Management Kit Vascular Tray  REF: K10T-05261", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "864 units", "codes": "UDI: 00884450320297/ Lot: T2736369 T2781930 T2898771S T3047503 T3090431 T3121937 T3146114 T3158708 T3204129 T3232415", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1125-2026%22", "url": "https://recallledger.net/recalls/device-z-1125-2026-merit-medical-custom-waste-management-kit-vascular-tray-ref-k10t-0/"}, {"id": "fda-device-z-1124-2026", "source": "FDA", "category": "device", "recall_number": "Z-1124-2026", "title": "Allwell Inflation Device recall (Merit Medical Systems, Inc.)", "product": "Allwell Inflation Device, for angiographic use REF: IS-30-A", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "173,645 units", "codes": "UDI: 00884450653500 /Lot: I2559701 I2563344 I2567488 I2578111 I2593681 I2593683 I2603907 I2617788 I2622059 I2628990 I2653159 I2657407 I2853633 I2887859 I2887860 I2892046 I2917191 I2921522 I2927924 I2933535 I2989185 I2989187 I3027377 I3027378 I3037369 I3085686 I3085687 I3103552 I3118248 I3118249 I3154769 I3186052 I3186054 I3186058 I3214004 I3245239 I3245240 I3248078 I3282794", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1124-2026%22", "url": "https://recallledger.net/recalls/device-z-1124-2026-allwell-inflation-device-for-angiographic-use-ref-is-30-a/"}, {"id": "fda-device-z-1123-2026", "source": "FDA", "category": "device", "recall_number": "Z-1123-2026", "title": "Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL  Reference Numbers:... recall (Merit Medical Systems, Inc.)", "product": "Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL  Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A", "reason": "Inflation device handle may detach from the syringe during procedure.", "hazard_level": "Class II", "company": "Merit Medical Systems, Inc.", "company_location": "South Jordan, UT, United States", "date": "2025-12-04", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY,  St. Thomas , Puerto Rico and the countries of  Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago,  Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "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", "TN", "TX", "UT", "VA", "VT", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "4,163,123 units", "codes": "Reference Number/UDI Number/Lot Number(s) ENDO-AN2030/B 00884450645161 I2559664  00884450645161 I2617758  00884450645161 I2622046  00884450645161 I2657805  00884450645161 I2937082  00884450645161 I3056430  00884450645161 I3085664  00884450645161 I3118225  00884450645161 I3251180  00884450645161 I3282751 IN4130/CNK 00884450636695 I2559550  00884450636695 I2559551  00884450636695 I2563338  00884450636695 I2563339  00884450636695 I2563340  00884450636695 I2564655  00884450636695 I2564665  00884450636695 I2567481  00884450636695 I2567482  00884450636695 I2567483  00884450636695 I2578099  00884450636695 I2578100  00884450636695 I2584021  00884450636695 I2584024  00884450636695 I2584025  00884450636695 I2584026  00884450636695 I2607299  00884450636695 I2607301  00884450636695 I2607302  00884450636695 I2617759  00884450636695 I2617760  00884450636695 I2628998  00884450636695 I2629000  00884450636695 I2629001  00884450636695 I2629002  00884450636695 I2630702  00884450636695 I2648658  00884450636695 I2648659  00884450636695 I2648660  00884450636695 I2648661  00884450636695 I2657828  00884450636695 I2657833  00884450636695 I2657884  00884450636695 I2657889  00884450636695 I2663025  00884450636695 I2663026  00884450636695 I2663027  00884450636695 I2669899  00884450636695 I2669900  00884450636695 I2674531  00884450636695 I2674532  00884450636695 I2682701  00884450636695 I2682702  00884450636695 I2684463  00884450636695 I2684522  00884450636695 I2684523  00884450636695 I2699591  00884450636695 I2699592  00884450636695 I2703002  00884450636695 I2703003  00884450636695 I2703004  00884450636695 I2703006  00884450636695 I2703081  00884450636695 I2703082  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00884450636695 I3072605  00884450636695 I3074753  00884450636695 I3074754  00884450636695 I3074755  00884450636695 I3074756  00884450636695 I3079091  00884450636695 I3079092  00884450636695 I3079093  00884450636695 I3079094  00884450636695 I3079095  00884450636695 I3079096  00884450636695 I3085666  00884450636695 I3085667  00884450636695 I3085668  00884450636695 I3097690  00884450636695 I3097691  00884450636695 I3098952  00884450636695 I3098953  00884450636695 I3098955  00884450636695 I3118226  00884450636695 I3118227  00884450636695 I3118228  00884450636695 I3118230  00884450636695 I3129660  00884450636695 I3129661  00884450636695 I3129662  00884450636695 I3129663  00884450636695 I3129664  00884450636695 I3146015  00884450636695 I3146016  00884450636695 I3150024  00884450636695 I3150025  00884450636695 I3150028  00884450636695 I3150029  00884450636695 I3161167  00884450636695 I3161168  00884450636695 I3161169  00884450636695 I3161170  00884450636695 I3186043  00884450636695 I3186044  00884450636695 I3186047  00884450636695 I3186048  00884450636695 I3186064  00884450636695 I3186065  00884450636695 I3204095  00884450636695 I3204096  00884450636695 I3204119  00884450636695 I3204120  00884450636695 I3204124  00884450636695 I3213949  00884450636695 I3232111  00884450636695 I3232118  00884450636695 I3232119  00884450636695 I3237621  00884450636695 I3237646  00884450636695 I3251181  00884450636695 I3251182  00884450636695 I3251183  00884450636695 I3251184  00884450636695 I3251185  00884450636695 I3251186 IN4130/H 00884450636695 I2623447  00884450636695 I2639668  00884450636695 I2657810  00884450636695 I2663024  00884450636695 I2976522  00884450636695 I2989138  00884450636695 I3014317  00884450636695 I3014321  00884450636695 I3023697  00884450636695 I3098957  00884450636695 I3118231  00884450636695 I3161171  00884450636695 I3186059  00884450636695 I3204098  00884450636695 I3213970  00884450636695 I3213991  00884450636695 I3282764 IN4130/JPH 00884450636695 I2563341  00884450636695 I2584111  00884450636695 I2593621  00884450636695 I2600945  00884450636695 I2617761  00884450636695 I2622049  00884450636695 I2648662  00884450636695 I2648663  00884450636695 I2812806  00884450636695 I2813127  00884450636695 I2819767  00884450636695 I2868572  00884450636695 I2887840  00884450636695 I2892034  00884450636695 I2917168  00884450636695 I2921906  00884450636695 I2927912  00884450636695 I2976523  00884450636695 I3001132  00884450636695 I3014322  00884450636695 I3023700  00884450636695 I3037358  00884450636695 I3074757  00884450636695 I3085670  00884450636695 I3098958  00884450636695 I3110563  00884450636695 I3146019  00884450636695 I3200761  00884450636695 I3213973  00884450636695 I3232041  00884450636695 I3262820  00884450636695 I3282766 IN4130/K 00884450637524 I2719948  00884450637524 I2559561  00884450637524 I2572851  00884450637524 I2572852  00884450637524 I2617762  00884450637524 I2649063  00884450637524 I2649065  00884450637524 I2707737  00884450637524 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I3098979  00884450638460 I3129680  00884450638460 I3146047  00884450638460 I3213979  00884450638460 I3248082  00884450638460 I3282787 IN4908 00884450544570 I2623336  00884450544570 I2654504  00884450544570 I2684552  00884450544570 I2794463  00884450544570 I2839307  00884450544570 I2892042  00884450544570 I2903564  00884450544570 I2988261S1  00884450544570 I2989180  00884450544570 I3043208  00884450544570 I3056451  00884450544570 I3098980  00884450544570 I3129681  00884450544570 I3204100  00884450544570 I3232095  00884450544570 I3262837 IN4909 00884450544587 I2639691  00884450544587 I2684549  00884450544587 I2693461  00884450544587 I2853630  00884450544587 I2858652  00884450544587 I2891843  00884450544587 I2915034  00884450544587 I2921921  00884450544587 I2927918  00884450544587 I2989178  00884450544587 I3014368  00884450544587 I3023715  00884450544587 I3031158  00884450544587 I3056452  00884450544587 I3098981  00884450544587 I3110572  00884450544587 I3146048  00884450544587 I3161258  00884450544587 I3204105  00884450544587 I3226196  00884450544587 I3232116  00884450544587 I3248083  00884450544587 I3282789  00884450544587 I3298686 IN4910 00884450544594 I3152059  00884450544594 I3333097 IN4911/A 00884450638477 I2629018  00884450638477 I2678041  00884450638477 I2693462  00884450638477 I2719972  00884450638477 I2738936  00884450638477 I2773993  00884450638477 I2839312  00884450638477 I2868614  00884450638477 I2903566  00884450638477 I2903567  00884450638477 I2917187  00884450638477 I2921923  00884450638477 I2927919  00884450638477 I2927921  00884450638477 I2933529  00884450638477 I2976570  00884450638477 I2989184  00884450638477 I3014369  00884450638477 I3014370  00884450638477 I3023716  00884450638477 I3031159  00884450638477 I3031160  00884450638477 I3053785  00884450638477 I3056454  00884450638477 I3057825  00884450638477 I3097703  00884450638477 I3118246  00884450638477 I3129682  00884450638477 I3186060  00884450638477 I3204112  00884450638477 I3213984  00884450638477 I3248093  00884450638477 I3262841  00884450638477 I3290597  00884450638477 I3298687  00884450638477 I3333099 IN4912 00884450544617 I2593678  00884450544617 I2617785  00884450544617 I2639688  00884450544617 I2812812  00884450544617 I2892043  00884450544617 I2921924  00884450544617 I2927922  00884450544617 I2976571  00884450544617 I3079115  00884450544617 I3110574  00884450544617 I3129684  00884450544617 I3200774  00884450544617 I3213980  00884450544617 I3251196  00884450544617 I3282790  00884450544617 I3298688 IN4913/A 00884450638484 I2684555  00884450638484 I2693463  00884450638484 I2759884  00884450638484 I2834505  00884450638484 I2853632  00884450638484 I2868615  00884450638484 I2933532  00884450638484 I2976572  00884450638484 I3031161  00884450638484 I3048396  00884450638484 I3074780  00884450638484 I3119310  00884450638484 I3200775  00884450638484 I3213972  00884450638484 I3232073 IN4914/A 00884450638491 I2684547  00884450638491 I2707743  00884450638491 I2827045  00884450638491 I2976573  00884450638491 I3014371  00884450638491 I3074782  00884450638491 I3079116  00884450638491 I3146049  00884450638491 I3204116  00884450638491 I3298689 IN4915 00884450544648 I2607298  00884450544648 I2617786  00884450544648 I2629010  00884450544648 I2648691  00884450544648 I2657803  00884450544648 I2684554  00884450544648 I2693465  00884450544648 I2738938  00884450544648 I2827046  00884450544648 I2839316  00884450544648 I2858644  00884450544648 I2885752  00884450544648 I2892044  00884450544648 I2917188  00884450544648 I2921925  00884450544648 I2927923  00884450544648 I2976574  00884450544648 I3001147  00884450544648 I3085684  00884450544648 I3097705  00884450544648 I3110575  00884450544648 I3129222  00884450544648 I3161288  00884450544648 I3204111  00884450544648 I3226333  00884450544648 I3232109  00884450544648 I3262842 IN4916/A 00884450544648 I2629021  00884450544648 I2639674  00884450544648 I2892045  00884450544648 I2921926  00884450544648 I2976575  00884450544648 I3022141  00884450544648 I3119234  00884450544648 I3130590  00884450544648 I3204101  00884450544648 I3251197  00884450544648 I3279574 IN4917/A 00884450638514 I2559659  00884450638514 I2578110  00884450638514 I2593680  00884450638514 I2648692  00884450638514 I2648693  00884450638514 I2678040  00884450638514 I2903572  00884450638514 I2917190  00884450638514 I2921927  00884450638514 I2976576  00884450638514 I3037366  00884450638514 I3056455  00884450638514 I3110576  00884450638514 I3200777  00884450638514 I3204107  00884450638514 I3213956  00884450638514 I3231624 IN4918/A 00884450638521 I2693466  00884450638521 I2868616  00884450638521 I2903573  00884450638521 I2933533  00884450638521 I2976578  00884450638521 I3056456  00884450638521 I3074783  00884450638521 I3098982  00884450638521 I3146050  00884450638521 I3200779  00884450638521 I3275917  00884450638521 I3277193 IN4919/A 00884450638538 I2559662  00884450638538 I2584179  00884450638538 I2669854  00884450638538 I2759886  00884450638538 I2903576  00884450638538 I2915043  00884450638538 I2920389  00884450638538 I2933534  00884450638538 I2976579  00884450638538 I3056457  00884450638538 I3079117  00884450638538 I3085685  00884450638538 I3097706  00884450638538 I3275918  00884450638538 I3310676", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1123-2026%22", "url": "https://recallledger.net/recalls/device-z-1123-2026-merit-medical-inflation-device-basixcompak-30-atm-bar-20-ml-reference/"}, {"id": "fda-device-z-1122-2026", "source": "FDA", "category": "device", "recall_number": "Z-1122-2026", "title": "Mazor X robotic guidance system  REF: TPL0059 recall (Mazor Robotics Ltd)", "product": "Mazor X robotic guidance system  REF: TPL0059", "reason": "Software errors that can result in incorrect surgical instrument positioning during spinal surgery.", "hazard_level": "Class II", "company": "Mazor Robotics Ltd", "company_location": "Caesarea, Israel", "date": "2025-12-10", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, \tCanada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.", "states": ["PR"], "nationwide": true, "quantity": "549 systems", "codes": "Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1122-2026%22", "url": "https://recallledger.net/recalls/device-z-1122-2026-mazor-x-robotic-guidance-system-ref-tpl0059/"}, {"id": "fda-device-z-1120-2026", "source": "FDA", "category": "device", "recall_number": "Z-1120-2026", "title": "ICU Medical Plum Solo Precision IV Pump recall (ICU Medical, Inc.)", "product": "ICU Medical Plum Solo Precision IV Pump, List Numbers:  400010401 (US), 400011001 (Philippines)", "reason": "Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.", "hazard_level": "Class II", "company": "ICU Medical, Inc.", "company_location": "Lake Forest, IL, United States", "date": "2025-12-15", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Philippines.", "states": [], "nationwide": true, "quantity": "", "codes": "400010401 (US), Software Versions:  1.0.2;  400011001 (Philippines), Software Versions:  1.0.0", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1120-2026%22", "url": "https://recallledger.net/recalls/device-z-1120-2026-icu-medical-plum-solo-precision-iv-pump-list-numbers-400010401-us/"}, {"id": "fda-device-z-1119-2026", "source": "FDA", "category": "device", "recall_number": "Z-1119-2026", "title": "ICU Medical Plum Duo Precision IV Pump recall (ICU Medical, Inc.)", "product": "ICU Medical Plum Duo Precision IV Pump, List Numbers:  400020403 (US), 400021003 (Philippines)", "reason": "Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.", "hazard_level": "Class II", "company": "ICU Medical, Inc.", "company_location": "Lake Forest, IL, United States", "date": "2025-12-15", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Philippines.", "states": [], "nationwide": true, "quantity": "", "codes": "400020403 (US), Software Versions:  1.2.2;  400021003 (Philippines), Software Versions:  1.2.0", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1119-2026%22", "url": "https://recallledger.net/recalls/device-z-1119-2026-icu-medical-plum-duo-precision-iv-pump-list-numbers-400020403-us/"}, {"id": "fda-device-z-1118-2026", "source": "FDA", "category": "device", "recall_number": "Z-1118-2026", "title": "ICU Medical Plum Duo Infusion Pump recall (ICU Medical, Inc.)", "product": "ICU Medical Plum Duo Infusion Pump, List Numbers:  400020401 (US), 400021001 (Philippines)", "reason": "Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.", "hazard_level": "Class II", "company": "ICU Medical, Inc.", "company_location": "Lake Forest, IL, United States", "date": "2025-12-15", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the country of Philippines.", "states": [], "nationwide": true, "quantity": "", "codes": "400020401 (US), Software Versions:  1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions:  1.1.0", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2026%22", "url": "https://recallledger.net/recalls/device-z-1118-2026-icu-medical-plum-duo-infusion-pump-list-numbers-400020401-us-400/"}, {"id": "fda-device-z-1113-2026", "source": "FDA", "category": "device", "recall_number": "Z-1113-2026", "title": "Philips Azurion system recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Philips Azurion system; Software Version Number: R3.1;", "reason": "Philips has identified two (2) software issues affecting device systems that may result in loss of  imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content  and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error   Applicable only to systems with Poly-G3 frontal stand.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-12", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;", "states": ["AR", "AZ", "IL", "IN", "MA", "MO"], "nationwide": false, "quantity": "228 units (all OUS)", "codes": "Software Version Number: R3.1;  (1) Model Number: 722221; System Product Name: Azurion 3 M12; UDI-DI: 00884838099203; Serial Numbers:   (2) Model Number: 722222; System Product Name: Azurion 3 M15; UDI-DI: 00884838099210; Serial Numbers:  (3) Model Number: 722223; System Product Name: Azurion 7 M12; UDI-DI: 00884838099241; Serial Numbers:  (4) Model Number: 722224; System Product Name: Azurion 7 M20; UDI-DI: 00884838099258; Serial Numbers:  (5) Model Number: 722225; System Product Name: Azurion 7 B12; UDI-DI: 00884838099265; Serial Numbers:  (6) Model Number: 722226; System Product Name: Azurion 7 B20; UDI-DI: 00884838099272; Serial Numbers:  (7) Model Number: 722227; System Product Name: Azurion 5 M12; UDI-DI: 00884838099227; Serial Numbers:  (8) Model Number: 722228; System Product Name: Azurion 5 M20; UDI-DI: 00884838099234; Serial Numbers:  (9) Model Number: 722229; System Product Name: Azurion 3 M12; UDI-DI: 00884838116726; Serial Numbers: 5, 9, 32, 40, 35, 31, 33;  (10) Model Number: 722230; System Product Name: Azurion 3 M15; UDI-DI: 00884838116733; Serial Numbers: 25, 54, 50, 52, 55, 30, 63, 60, 67;  (11) Model Number: 722231; System Product Name: Azurion 5 M12; UDI-DI: 00884838116740; Serial Numbers: 62, 7, 8, 14, 17, 63, 6, 66, 59, 69, 56, 67, 48, 68, 80, 93, 87, 94, 81, 92, 18;  (12) Model Number: 722232; System Product Name: Azurion 5 M20; UDI-DI: 00884838116757; Serial Numbers: 97, 39, 31, 100, 104, 93, 115, 113, 118, 119, 89, 54, 67, 7, 128, 86, 110, 132, 130, 131, 123, 137, 139, 117, 260;  (13) Model Number: 722233; System Product Name: Azurion 7 M12; UDI-DI: 00884838116764; Serial Numbers: 239, 100, 233, 240, 176, 227, 223, 130, 161, 194, 243, 56, 193, 280, 75, 253, 156, 288, 72, 281, 304, 300, 105, 295, 312, 310, 285, 292, 290, 298, 297;  (14) Model Number: 722234; System Product Name: Azurion 7 M20; UDI-DI: 00884838116771; Serial Numbers: 731, 727, 261, 473, 683, 722, 562, 750, 745, 766, 265, 701, 400, 310, 421, 314, 182, 579, 96, 763, 272, 612, 15, 844, 105, 702, 751, 384, 851, 869, 743, 337, 651, 455, 706, 312, 563, 709, 764, 871, 846, 278, 713, 802, 868, 277, 742, 184, 819, 759, 910, 928, 415, 414, 945, 961, 355, 933, 692, 920, 569, 939, 909, 553, 837, 856, 571, 756, 941, 570, 761, 981, 353, 888, 964, 820, 746, 736, 876, 599, 1017, 908, 487, 983, 495;  (15) Model Number: 722235; System Product Name: Azurion 7 B12; UDI-DI: 00884838116788; Serial Numbers: 96, 79, 111, 100, 101, 38, 27, 92, 78, 118, 48, 131, 135, 22, 125, 103, 138, 139, 137;  (16) Model Number: 722236; System Product Name: Azurion 7 B20; UDI-DI: 00884838116801; Serial Numbers: 241, 297, 198, 215, 305, 274, 299, 78, 279, 287, 318, 353, 324, 331, 293, 245, 314, 310, 317, 312, 77, 358, 206, 383, 380, 370, 377, 385, 405, 379, 328;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1113-2026%22", "url": "https://recallledger.net/recalls/device-z-1113-2026-philips-azurion-system-software-version-number-r3-1/"}, {"id": "fda-device-z-1112-2026", "source": "FDA", "category": "device", "recall_number": "Z-1112-2026", "title": "GE Healthcare Omni Legend recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)", "product": "GE Healthcare Omni Legend, sold under the following names:    OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm   WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile   WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission", "reason": "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images.  This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).", "hazard_level": "Class II", "company": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "company_location": "Haifa, Israel", "date": "2025-12-24", "report_date": "2026-01-28", "status": "Completed", "distribution": "Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Korea (Republic Of), Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, United Kingdom, and Uzbekistan.", "states": [], "nationwide": true, "quantity": "364 units", "codes": "OMNI Legend 16:  UDI (01)00195278454218(21)OM3D31087(11)240400, Manufacturing Lot/Serial Number OM3D31087;  OMNI Legend 16:  UDI (01)00195278454218(21)OM3D31071(11)240200, Manufacturing Lot/Serial Number OM3D31071;  OMNI Legend 16:  UDI (01)00195278454218(21)OM3D31100(11)240700, Manufacturing Lot/Serial Number OM3D31100;  OMNI Legend 16:  UDI (01)00195278454218(21)OM3E31115(11)250100, Manufacturing Lot/Serial Number OM3E31115;  OMNI Legend 16:  UDI (01)00195278592309(21)OH3D35001(11)240600, Manufacturing Lot/Serial Number OH3D35001;  OMNI Legend 16:  UDI (01)00195278592309(21)OH3E35003(11)250100, Manufacturing Lot/Serial Number OH3E35003;  Omni Legend 21:  UDI (01)00195278454218(21)OM4E44014(11)250400, Manufacturing Lot/Serial Number OM4E44014;  Omni Legend 21:  UDI (01)00195278454218(21)OM4E44012(11)250200, Manufacturing Lot/Serial Number OM4E44012;  Omni Legend 21:  UDI (01)00195278592309(21)OH4E43004(11)250400, Manufacturing Lot/Serial Number OH4E43004;  Omni Legend 21:  UDI (01)00195278592309(21)OH4E43001(11)250100, Manufacturing Lot/Serial Number OH4E43001;  Omni Legend 21:  UDI (01)00195278592309(21)OH4E43002(11)250100, Manufacturing Lot/Serial Number OH4E43002;  OMNI Legend 32:  UDI (01)00195278454218(21)OM6E61101(11)250400, Manufacturing Lot/Serial Number OM6E61101;  OMNI Legend 32:  UDI (01)00195278454218(21)OM6D61084(11)240900, Manufacturing Lot/Serial Number OM6D61084;  OMNI Legend 32:  UDI (01)00195278454218(21)OM6C61031(11)230700, Manufacturing Lot/Serial Number OM6C61031;  OMNI Legend 32:  UDI (01)00195278454218(21)OM6E61097(11)250200, Manufacturing Lot/Serial Number OM6E61097;  OMNI Legend 32:  UDI (01)00195278454218(21)OM6D61072(11)240600, Manufacturing Lot/Serial Number OM6D61072;  Omni Legend PET Gantry 16cm - MEA:  UDI (01)00195278792822(11)250623(21)NL1EG2500002BH, Manufacturing Lot/Serial Number NL1EG2500002BH/ CBDDG2500041HM/ C1PMT2500115HM;  Omni Legend PET Gantry 16cm - MEA:  UDI (01)00195278792822(11)240900(21)NL1EG2400002BH, Manufacturing Lot/Serial Number NL1EG2400002BH/ CBDDG2400112HM/ C1PMT2400271HM;  Omni Legend PET Gantry 16cm - MEA:  UDI (01)00195278792822(11)240600(21)NL1EG2400001BH, Manufacturing Lot/Serial Number NL1EG2400001BH /CBDDG2400079HM/C1PMT2400151HM;  Omni Legend PET Gantry 16cm - MEA:  UDI (01)00195278792822(11)250100(21)NL1EG2400003BH, Manufacturing Lot/Serial Number NL1EG2400003BH/ NL1EG2400003BH /CBDDG2400144HM/ C1PMT2400123HM;  Omni Legend PET Gantry 16cm - MEA:  UDI (01)00195278792822(11)250400(21)NL1EG2500001BH, Manufacturing Lot/Serial Number NL1EG2500001BH/ CBDDG2500026HM/ C1PMT2500074HM;  Omni Legend PET Gantry 16cm Haifa LM:  UDI (01)00195278592309(21)OH3D35002(11)241000, Manufacturing Lot/Serial Number OH3D35002;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32001(11)230600, Manufacturing Lot/Serial Number OW3C32001;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32002(11)230700, Manufacturing Lot/Serial Number OW3C32002;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32003(11)230900, Manufacturing Lot/Serial Number OW3C32003;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32006(11)231000, Manufacturing Lot/Serial Number OW3C32006;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32010(11)231100, Manufacturing Lot/Serial Number OW3C32010;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32018(11)240500, Manufacturing Lot/Serial Number OW3D32018;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32021(11)241000, Manufacturing Lot/Serial Number OW3D32021;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32013(11)240100, Manufacturing Lot/Serial Number OW3D32013;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32007(11)231000, Manufacturing Lot/Serial Number OW3C32007;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32020(11)240700, Manufacturing Lot/Serial Number OW3D32020;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32019(11)240500, Manufacturing Lot/Serial Number OW3D32019;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32014(11)240100, Manufacturing Lot/Serial Number OW3D32014;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32015(11)240100, Manufacturing Lot/Serial Number OW3D32015;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32004(11)230900, Manufacturing Lot/Serial Number OW3C32004;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32011(11)231200, Manufacturing Lot/Serial Number OW3C32011;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32005(11)231000, Manufacturing Lot/Serial Number OW3C32005;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32008(11)231000, Manufacturing Lot/Serial Number OW3C32008;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32016(11)240300, Manufacturing Lot/Serial Number OW3D32016;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3D32012(11)240100, Manufacturing Lot/Serial Number OW3D32012;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3C32009(11)231000, Manufacturing Lot/Serial Number OW3C32009;  Omni Legend PET Gantry 16cm Mobile:  UDI (01)00195278454218(21)OW3E32022(11)250400, Manufacturing Lot/Serial Number OW3E32022;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)241000(21)NL1FG2400003BH, Manufacturing Lot/Serial Number NL1FG2400003BH /CBDDG2400119HM/ C1PMT2400296HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)241000(21)NL1FG2400004BH, Manufacturing Lot/Serial Number NL1FG2400004BH /CBDDG2400121HM/ C1PMT2400305HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)241200(21)NL1FG2500001BH, Manufacturing Lot/Serial Number NL1FG2500001BH/ CBDDG2400143HM /C1PMT2300279HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)250200(21)NL1FG2500002BH, Manufacturing Lot/Serial Number NL1FG2500002BH/ CBDDG2500009HM/ C1PMT2500018HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)250506(21)NL1FG2500003BH, Manufacturing Lot/Serial Number NL1FG2500003BH/ CBDDG2500030HM/ C1PMT2500083HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)240500(21)NL1FG2400001BH, Manufacturing Lot/Serial Number NL1FG2400001BH/ CBDDG2400063HM/ C1PMT2400126HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)240900(21)NL1FG2400002BH, Manufacturing Lot/Serial Number NL1FG2400002BH/ CBDDG2400109HM/ C1PMT2400245HM;  Omni Legend PET Gantry 21cm - BJ for Global:  UDI (01)00195278792822(11)250509(21)NL1FG2500004BH, Manufacturing Lot/Serial Number NL1FG2500004BH/ CBDDG2500032HM/ C1PMT2500086HM;  Omni Legend PET Gantry 21cm - Global Haifa LM:  UDI (01)00195278592309(21)OH4E43005(11)250609, Manufacturing Lot/Serial Number OH4E43005;  Omni Legend PET Gantry 21cm - Global Haifa LM:  UDI (01)00195278592309(21)OH4E43003(11)250300, Manufacturing Lot/Serial Number OH4E43003;  Omni Legend PET Gantry 21cm - Mobile:  UDI (01)00195278454218(21)OW4D47001(11)241100, Manufacturing Lot/Serial Number OW4D47001;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44003(11)240800, Manufacturing Lot/Serial Number OM4D44003;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44009(11)241100, Manufacturing Lot/Serial Number OM4D44009;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44002(11)240500, Manufacturing Lot/Serial Number OM4D44002;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44006(11)241000, Manufacturing Lot/Serial Number OM4D44006;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44017(11)250528, Manufacturing Lot/Serial Number OM4E44017;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44008(11)241100, Manufacturing Lot/Serial Number OM4D44008;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44005(11)241000, Manufacturing Lot/Serial Number OM4D44005;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44015(11)250512, Manufacturing Lot/Serial Number OM4E44015;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44013(11)250300, Manufacturing Lot/Serial Number OM4E44013;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44010(11)250300, Manufacturing Lot/Serial Number OM4E44010;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44007(11)241100, Manufacturing Lot/Serial Number OM4D44007;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44016(11)250525, Manufacturing Lot/Serial Number OM4E44016;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44001(11)240300, Manufacturing Lot/Serial Number OM4D44001;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4E44011(11)250200, Manufacturing Lot/Serial Number OM4E44011;  Omni Legend PET Gantry 21cm   WSO LM:  UDI (01)00195278454218(21)OM4D44004(11)240900, Manufacturing Lot/Serial Number OM4D44004;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)241000(21)NL1DG2400006BH, Manufacturing Lot/Serial Number NL1DG2400006BH /CBDDG2400115HM /C1PMT2400277HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250619(21)NL1DG2500007BH, Manufacturing Lot/Serial Number NL1DG2500007BH/ CBDDG2500042HM/C1PMT2500116HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)240700(21)NL1DG2400003BH, Manufacturing Lot/Serial Number NL1DG2400003BH/ CBDDG2400091HM/ C1PMT2400185HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250521(21)NL1DG2500005BH, Manufacturing Lot/Serial Number NL1DG2500005BH/ CBDDG2500037HM/ C1PMT2500093HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250702(21)NL1DG2500008BH, Manufacturing Lot/Serial Number NL1DG2500008BH/ CBDDG2500043HM/ C1PMT2500121HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250515(21)NL1DG2500004BH, Manufacturing Lot/Serial Number NL1DG2500004BH/ CBDDG2500034HM/ C1PMT2500089HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)240700(21)NL1DG2400002BH, Manufacturing Lot/Serial Number NL1DG2400002BH/ CBDDG2400083HM/ C1PMT2400172HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)240700(21)NL1DG2400004BH, Manufacturing Lot/Serial Number NL1DG2400004BH/ CBDDG2400096HM /C1PMT2400197HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250611(21)NL1DG2500006BH, Manufacturing Lot/Serial Number NL1DG2500006BH/ CBDDG2500040HM/ C1PMT2500111HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)231100(21)NL1DG2400001BH, Manufacturing Lot/Serial Number NL1DG2400001BH;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250200(21)NL1DG2500002BH, Manufacturing Lot/Serial Number NL1DG2500002BH/ CBDDG2500015HM/ C1PMT2500053HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)241100(21)NL1DG2400007BH, Manufacturing Lot/Serial Number NL1DG2400007BH /CBDDG2400131HM/ C1PMT2400328HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)240800(21)NL1DG2400005BH, Manufacturing Lot/Serial Number NL1DG2400005BH/ CBDDG2400108HM /C1PMT2400226;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)241200(21)NL1DG2400008BH, Manufacturing Lot/Serial Number NL1DG2400008BH/ CBDDG2400142HM/ C1PMT2400342HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250400(21)NL1DG2500003BH, Manufacturing Lot/Serial Number NL1DG2500003BH /CBDDG2500025HM/ C1PMT2500071HM;  Omni Legend PET Gantry 32cm - MEA:  UDI (01)00195278792822(11)250100(21)NL1DG2500001BH, Manufacturing Lot/Serial Number NL1DG2500001BH/ CBDDG2500007HM/ C1PMT2500012HM;  Omni Legend PET Gantry 32cm Haifa LM:  UDI (01)00195278592309(21)OH6D66004(11)241100, Manufacturing Lot/Serial Number OH6D66004;  Omni Legend PET Gantry 32cm Haifa LM:  UDI (01)00195278592309(21)OH6D66001(11)240200, Manufacturing Lot/Serial Number OH6D66001;  Omni Legend PET Gantry 32cm Haifa LM:  UDI (01)00195278592309(21)OH6D66002(11)240500, Manufacturing Lot/Serial Number OH6D66002;  Omni Legend PET Gantry 32cm Haifa LM:  UDI (01)00195278592309(21)OH6D66003(11)241000, Manufacturing Lot/Serial Number OH6D66003;  Omni Legend PET Gantry 32cm Mobile:  UDI (01)00195278454218(21)OW6D62001(11)240200, Manufacturing Lot/Serial Number OW6D62001;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31063(11)240100, Manufacturing Lot/Serial Number OM3D31063;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31072(11)240200, Manufacturing Lot/Serial Number OM3D31072;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31064(11)240100, Manufacturing Lot/Serial Number OM3D31064;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31050(11)231100, Manufacturing Lot/Serial Number OM3C31050;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31044(11)231100, Manufacturing Lot/Serial Number OM3C31044;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31058(11)240100, Manufacturing Lot/Serial Number OM3D31058;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31009(11)230200, Manufacturing Lot/Serial Number OM3C31009;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31065(11)240100, Manufacturing Lot/Serial Number OM3D31065;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31040(11)231000, Manufacturing Lot/Serial Number OM3C31040;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31025(11)230600, Manufacturing Lot/Serial Number OM3C31025;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31059(11)240100, Manufacturing Lot/Serial Number OM3D31059;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31069(11)240200, Manufacturing Lot/Serial Number OM3D31069;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31034(11)230800, Manufacturing Lot/Serial Number OM3C31034;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31015(11)230300, Manufacturing Lot/Serial Number OM3C31015;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31021(11)230500, Manufacturing Lot/Serial Number OM3C31021;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31102(11)240700, Manufacturing Lot/Serial Number OM3D31102;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31103(11)240700, Manufacturing Lot/Serial Number OM3D31103;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31061(11)240100, Manufacturing Lot/Serial Number OM3D31061;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31091(11)240500, Manufacturing Lot/Serial Number OM3D31091;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31079(11)240400, Manufacturing Lot/Serial Number OM3D31079;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31006(11)230100, Manufacturing Lot/Serial Number OM3C31006;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31074(11)240200, Manufacturing Lot/Serial Number OM3D31074;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31056(11)240100, Manufacturing Lot/Serial Number OM3D31056;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31042(11)231000, Manufacturing Lot/Serial Number OM3C31042;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31097(11)240600, Manufacturing Lot/Serial Number OM3D31097;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31007(11)230100, Manufacturing Lot/Serial Number OM3C31007;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31053(11)231100, Manufacturing Lot/Serial Number OM3C31053;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31038(11)231000, Manufacturing Lot/Serial Number OM3C31038;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31081(11)240400, Manufacturing Lot/Serial Number OM3D31081;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31062(11)240100, Manufacturing Lot/Serial Number OM3D31062;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31090(11)240500, Manufacturing Lot/Serial Number OM3D31090;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31043(11)231100, Manufacturing Lot/Serial Number OM3C31043;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31075(11)240200, Manufacturing Lot/Serial Number OM3D31075;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31078(11)240400, Manufacturing Lot/Serial Number OM3D31078;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31084(11)240400, Manufacturing Lot/Serial Number OM3D31084;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31028(11)230700, Manufacturing Lot/Serial Number OM3C31028;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31037(11)231000, Manufacturing Lot/Serial Number OM3C31037;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31114(11)241200, Manufacturing Lot/Serial Number OM3D31114;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31104(11)240700, Manufacturing Lot/Serial Number OM3D31104;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31066(11)240100, Manufacturing Lot/Serial Number OM3D31066;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31014(11)230300, Manufacturing Lot/Serial Number OM3C31014;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31027(11)230700, Manufacturing Lot/Serial Number OM3C31027;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3B31004(11)221200, Manufacturing Lot/Serial Number OM3B31004;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31086(11)240400, Manufacturing Lot/Serial Number OM3D31086;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31024(11)230600, Manufacturing Lot/Serial Number OM3C31024;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31080(11)240400, Manufacturing Lot/Serial Number OM3D31080;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31096(11)240600, Manufacturing Lot/Serial Number OM3D31096;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31047(11)231100, Manufacturing Lot/Serial Number OM3C31047;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31035(11)230800, Manufacturing Lot/Serial Number OM3C31035;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31085(11)240400, Manufacturing Lot/Serial Number OM3D31085;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31011(11)230200, Manufacturing Lot/Serial Number OM3C31011;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31008(11)230200, Manufacturing Lot/Serial Number OM3C31008;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31049(11)231100, Manufacturing Lot/Serial Number OM3C31049;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31073(11)240200, Manufacturing Lot/Serial Number OM3D31073;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31093(11)240500, Manufacturing Lot/Serial Number OM3D31093;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31022(11)230500, Manufacturing Lot/Serial Number OM3C31022;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31101(11)240700, Manufacturing Lot/Serial Number OM3D31101;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31033(11)230800, Manufacturing Lot/Serial Number OM3C31033;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31077(11)240400, Manufacturing Lot/Serial Number OM3D31077;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31105(11)240700, Manufacturing Lot/Serial Number OM3D31105;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31010(11)230200, Manufacturing Lot/Serial Number OM3C31010;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31020(11)230500, Manufacturing Lot/Serial Number OM3C31020;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3B31005(11)221200, Manufacturing Lot/Serial Number OM3B31005;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31013(11)230300, Manufacturing Lot/Serial Number OM3C31013;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31076(11)240400, Manufacturing Lot/Serial Number OM3D31076;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31088(11)240500, Manufacturing Lot/Serial Number OM3D31088;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31051(11)231100, Manufacturing Lot/Serial Number OM3C31051;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31095(11)240500, Manufacturing Lot/Serial Number OM3D31095;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31055(11)240100, Manufacturing Lot/Serial Number OM3D31055;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31023(11)230500, Manufacturing Lot/Serial Number OM3C31023;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3B31001(11)220600, Manufacturing Lot/Serial Number OM3B31001;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31029(11)230700, Manufacturing Lot/Serial Number OM3C31029;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31019(11)230500, Manufacturing Lot/Serial Number OM3C31019;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31041(11)231000, Manufacturing Lot/Serial Number OM3C31041;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31016(11)230300, Manufacturing Lot/Serial Number OM3C31016;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31032(11)230800, Manufacturing Lot/Serial Number OM3C31032;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31094(11)240500, Manufacturing Lot/Serial Number OM3D31094;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31089(11)240500, Manufacturing Lot/Serial Number OM3D31089;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31057(11)240100, Manufacturing Lot/Serial Number OM3D31057;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31107(11)240800, Manufacturing Lot/Serial Number OM3D31107;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31036(11)230900, Manufacturing Lot/Serial Number OM3C31036;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31030(11)230700, Manufacturing Lot/Serial Number OM3C31030;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31012(11)230200, Manufacturing Lot/Serial Number OM3C31012;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31083(11)240400, Manufacturing Lot/Serial Number OM3D31083;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31031(11)230800, Manufacturing Lot/Serial Number OM3C31031;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31112(11)241100, Manufacturing Lot/Serial Number OM3D31112;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31110(11)240800, Manufacturing Lot/Serial Number OM3D31110;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3E31116(11)250100, Manufacturing Lot/Serial Number OM3E31116;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31092(11)240500, Manufacturing Lot/Serial Number OM3D31092;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31113(11)241100, Manufacturing Lot/Serial Number OM3D31113;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31052(11)231100, Manufacturing Lot/Serial Number OM3C31052;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3E31117(11)250400, Manufacturing Lot/Serial Number OM3E31117;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3B31003(11)221100, Manufacturing Lot/Serial Number OM3B31003;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31070(11)240200, Manufacturing Lot/Serial Number OM3D31070;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31067(11)240200, Manufacturing Lot/Serial Number OM3D31067;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31046(11)231100, Manufacturing Lot/Serial Number OM3C31046;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31048(11)231100, Manufacturing Lot/Serial Number OM3C31048;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31039(11)231000, Manufacturing Lot/Serial Number OM3C31039;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31099(11)240700, Manufacturing Lot/Serial Number OM3D31099;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31098(11)240600, Manufacturing Lot/Serial Number OM3D31098;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31111(11)240900, Manufacturing Lot/Serial Number OM3D31111;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3E31118(11)250500, Manufacturing Lot/Serial Number OM3E31118;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31109(11)240900, Manufacturing Lot/Serial Number OM3D31109;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31108(11)240800, Manufacturing Lot/Serial Number OM3D31108;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31068(11)240200, Manufacturing Lot/Serial Number OM3D31068;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31106(11)240800, Manufacturing Lot/Serial Number OM3D31106;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31054(11)231200, Manufacturing Lot/Serial Number OM3C31054;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31017(11)230500, Manufacturing Lot/Serial Number OM3C31017;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31018(11)230500, Manufacturing Lot/Serial Number OM3C31018;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3C31026(11)230600, Manufacturing Lot/Serial Number OM3C31026;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31060(11)240100, Manufacturing Lot/Serial Number OM3D31060;  OMNI PET Gantry 15cm:  UDI (01)00195278454218(21)OM3D31082(11)240400, Manufacturing Lot/Serial Number OM3D31082;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250708(21)OMW152500014PT, Manufacturing Lot/Serial Number OMW152500014PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)241004(21)OMW152400004PT, Manufacturing Lot/Serial Number OMW152400004PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)241213(21)OMW152400008PT, Manufacturing Lot/Serial Number OMW152400008PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250102(21)OMW152500010PT, Manufacturing Lot/Serial Number OMW152500010PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)241106(21)OMW152400006PT, Manufacturing Lot/Serial Number OMW152400006PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250410(21)OMW152500012PT, Manufacturing Lot/Serial Number OMW152500012PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250423(21)OMW152500013PT, Manufacturing Lot/Serial Number OMW152500013PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250102(21)OMW152500009PT, Manufacturing Lot/Serial Number OMW152500009PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)240926(21)OMW152400003PT, Manufacturing Lot/Serial Number OMW152400003PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250310(21)OMW152500011PT, Manufacturing Lot/Serial Number OMW152500011PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)241028(21)OMW152400005PT, Manufacturing Lot/Serial Number OMW152400005PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250710(21)OMW152500015PT, Manufacturing Lot/Serial Number OMW152500015PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)241114(21)OMW152400007PT, Manufacturing Lot/Serial Number OMW152400007PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)240919(21)OMW152400002PT, Manufacturing Lot/Serial Number OMW152400002PT;  Omni PET Gantry 15cm - WSO:  UDI (01)00195278901439(11)250102(21)OMW152500001PT, Manufacturing Lot/Serial Number OMW152500001PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250623(21)OMC152500008PT, Manufacturing Lot/Serial Number OMC152500008PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250520(21)OMC152500006PT, Manufacturing Lot/Serial Number OMC152500006PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250120(21)OMC152500001PT, Manufacturing Lot/Serial Number OMC152500001PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250325(21)OMC152500005PT, Manufacturing Lot/Serial Number OMC152500005PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250128(21)OMC152500002PT, Manufacturing Lot/Serial Number OMC152500002PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241209(21)OMC152400007PT, Manufacturing Lot/Serial Number OMC152400007PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241120(21)OMC152400004PT, Manufacturing Lot/Serial Number OMC152400004PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241211(21)OMC152400008PT, Manufacturing Lot/Serial Number OMC152400008PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241014(21)OMC152400001PT, Manufacturing Lot/Serial Number OMC152400001PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241018(21)OMC152400002PT, Manufacturing Lot/Serial Number OMC152400002PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250228(21)OMC152500003PT, Manufacturing Lot/Serial Number OMC152500003PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250321(21)OMC152500004PT, Manufacturing Lot/Serial Number OMC152500004PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241023(21)OMC152400003PT, Manufacturing Lot/Serial Number OMC152400003PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241125(21)OMC152400005PT, Manufacturing Lot/Serial Number OMC152400005PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)241204(21)OMC152400006PT, Manufacturing Lot/Serial Number OMC152400006PT;  OMNI PET Gantry 15cm Cardiac- WSO:  UDI (01)00195278901439(11)250612(21)OMC152500007PT, Manufacturing Lot/Serial Number OMC152500007PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250408(21)OMD152500004PT, Manufacturing Lot/Serial Number OMD152500004PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250304(21)OMD152500003PT, Manufacturing Lot/Serial Number OMD152500003PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250218(21)OMD152500002PT, Manufacturing Lot/Serial Number OMD152500002PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250603(21)OMD152500006PT, Manufacturing Lot/Serial Number OMD152500006PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250410(21)OMD152500005PT, Manufacturing Lot/Serial Number OMD152500005PT;  OMNI PET Gantry 15cm ES - WSO:  UDI (01)00195278901439(11)250213(21)OMD152500001PT, Manufacturing Lot/Serial Number OMD152500001PT;  Omni PET Gantry 15cm Mobile   WSO:  UDI (01)00195278901439(11)241217(21)OMM152400001PT, Manufacturing Lot/Serial Number OMM152400001PT;  Omni PET Gantry 15cm Mobile   WSO:  UDI (01)00195278901439(11)250206(21)OMM152500001PT, Manufacturing Lot/Serial Number OMM152500001PT;  Omni PET Gantry 15cm Mobile   WSO:  UDI (01)00195278901439(11)250410(21)OMM152500002PT, Manufacturing Lot/Serial Number OMM152500002PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250617(21)OMW212500007PT, Manufacturing Lot/Serial Number OMW212500007PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250220(21)OMW212500001PT, Manufacturing Lot/Serial Number OMW212500001PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250604(21)OMW212500006PT, Manufacturing Lot/Serial Number OMW212500006PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250519(21)OMW212500004PT, Manufacturing Lot/Serial Number OMW212500004PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250501(21)OMW212500003PT, Manufacturing Lot/Serial Number OMW212500003PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250313(21)OMW212500002PT, Manufacturing Lot/Serial Number OMW212500002PT;  Omni PET Gantry 21cm - WSO:  UDI (01)00195278901439(11)250529(21)OMW212500005PT, Manufacturing Lot/Serial Number OMW212500005PT;  Omni PET Gantry 21cm Mobile - WSO:  UDI (01)00195278901439(11)250710(21)OMM212500001PT, Manufacturing Lot/Serial Number OMM212500001PT;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61041(11)230900, Manufacturing Lot/Serial Number OM6C61041;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61020(11)230500, Manufacturing Lot/Serial Number OM6C61020;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61010(11)221100, Manufacturing Lot/Serial Number OM6B61010;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61070(11)240600, Manufacturing Lot/Serial Number OM6D61070;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61050(11)231100, Manufacturing Lot/Serial Number OM6C61050;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61053(11)231100, Manufacturing Lot/Serial Number OM6C61053;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61083(11)240800, Manufacturing Lot/Serial Number OM6D61083;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61021(11)230500, Manufacturing Lot/Serial Number OM6C61021;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61019(11)230500, Manufacturing Lot/Serial Number OM6C61019;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61065(11)240500, Manufacturing Lot/Serial Number OM6D61065;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61045(11)231000, Manufacturing Lot/Serial Number OM6C61045;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61024(11)230500, Manufacturing Lot/Serial Number OM6C61024;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61066(11)240500, Manufacturing Lot/Serial Number OM6D61066;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61040(11)230800, Manufacturing Lot/Serial Number OM6C61040;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61077(11)240800, Manufacturing Lot/Serial Number OM6D61077;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61028(11)230700, Manufacturing Lot/Serial Number OM6C61028;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61026(11)230600, Manufacturing Lot/Serial Number OM6C61026;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61058(11)240100, Manufacturing Lot/Serial Number OM6D61058;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61022(11)230500, Manufacturing Lot/Serial Number OM6C61022;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61068(11)240500, Manufacturing Lot/Serial Number OM6D61068;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61012(11)230100, Manufacturing Lot/Serial Number OM6B61012;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61037(11)230800, Manufacturing Lot/Serial Number OM6C61037;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61075(11)240700, Manufacturing Lot/Serial Number OM6D61075;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61025(11)230600, Manufacturing Lot/Serial Number OM6C61025;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61032(11)230700, Manufacturing Lot/Serial Number OM6C61032;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61004(11)221000, Manufacturing Lot/Serial Number OM6B61004;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61056(11)231200, Manufacturing Lot/Serial Number OM6C61056;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61059(11)240100, Manufacturing Lot/Serial Number OM6D61059;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61091(11)241000, Manufacturing Lot/Serial Number OM6D61091;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61087(11)240900, Manufacturing Lot/Serial Number OM6D61087;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61048(11)231000, Manufacturing Lot/Serial Number OM6C61048;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61099(11)250200, Manufacturing Lot/Serial Number OM6E61099;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61023(11)230500, Manufacturing Lot/Serial Number OM6C61023;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61036(11)230800, Manufacturing Lot/Serial Number OM6C61036;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61067(11)240500, Manufacturing Lot/Serial Number OM6D61067;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61029(11)230700, Manufacturing Lot/Serial Number OM6C61029;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61057(11)240100, Manufacturing Lot/Serial Number OM6D61057;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61096(11)250100, Manufacturing Lot/Serial Number OM6E61096;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61076(11)240700, Manufacturing Lot/Serial Number OM6D61076;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61030(11)230700, Manufacturing Lot/Serial Number OM6C61030;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61069(11)240600, Manufacturing Lot/Serial Number OM6D61069;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61042(11)230900, Manufacturing Lot/Serial Number OM6C61042;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61035(11)230700, Manufacturing Lot/Serial Number OM6C61035;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61062(11)240300, Manufacturing Lot/Serial Number OM6D61062;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61080(11)240800, Manufacturing Lot/Serial Number OM6D61080;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61054(11)231100, Manufacturing Lot/Serial Number OM6C61054;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61071(11)240600, Manufacturing Lot/Serial Number OM6D61071;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61085(11)240900, Manufacturing Lot/Serial Number OM6D61085;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61078(11)240800, Manufacturing Lot/Serial Number OM6D61078;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61064(11)240400, Manufacturing Lot/Serial Number OM6D61064;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61090(11)241000, Manufacturing Lot/Serial Number OM6D61090;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61033(11)230700, Manufacturing Lot/Serial Number OM6C61033;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61100(11)250400, Manufacturing Lot/Serial Number OM6E61100;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61011(11)221200, Manufacturing Lot/Serial Number OM6B61011;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61095(11)241200, Manufacturing Lot/Serial Number OM6D61095;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61104(11)250612, Manufacturing Lot/Serial Number OM6E61104;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61073(11)240700, Manufacturing Lot/Serial Number OM6D61073;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61081(11)240800, Manufacturing Lot/Serial Number OM6D61081;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61038(11)230800, Manufacturing Lot/Serial Number OM6C61038;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61008(11)221100, Manufacturing Lot/Serial Number OM6B61008;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61039(11)230800, Manufacturing Lot/Serial Number OM6C61039;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61074(11)240700, Manufacturing Lot/Serial Number OM6D61074;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61013(11)230100, Manufacturing Lot/Serial Number OM6C61013;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61014(11)230100, Manufacturing Lot/Serial Number OM6C61014;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61047(11)231000, Manufacturing Lot/Serial Number OM6C61047;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61034(11)230700, Manufacturing Lot/Serial Number OM6C61034;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61015(11)230100, Manufacturing Lot/Serial Number OM6C61015;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61006(11)221000, Manufacturing Lot/Serial Number OM6B61006;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61055(11)231100, Manufacturing Lot/Serial Number OM6C61055;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61061(11)240200, Manufacturing Lot/Serial Number OM6D61061;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61005(11)221000, Manufacturing Lot/Serial Number OM6B61005;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61051(11)231100, Manufacturing Lot/Serial Number OM6C61051;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61043(11)231000, Manufacturing Lot/Serial Number OM6C61043;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61094(11)241100, Manufacturing Lot/Serial Number OM6D61094;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61102(11)250400, Manufacturing Lot/Serial Number OM6E61102;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61079(11)240800, Manufacturing Lot/Serial Number OM6D61079;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61018(11)230400, Manufacturing Lot/Serial Number OM6C61018;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61009(11)221100, Manufacturing Lot/Serial Number OM6B61009;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61093(11)241100, Manufacturing Lot/Serial Number OM6D61093;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61044(11)231000, Manufacturing Lot/Serial Number OM6C61044;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61103(11)250603, Manufacturing Lot/Serial Number OM6E61103;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61001(11)220500, Manufacturing Lot/Serial Number OM6B61001;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61007(11)221100, Manufacturing Lot/Serial Number OM6B61007;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61063(11)240400, Manufacturing Lot/Serial Number OM6D61063;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61098(11)250200, Manufacturing Lot/Serial Number OM6E61098;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61016(11)230300, Manufacturing Lot/Serial Number OM6C61016;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61082(11)240800, Manufacturing Lot/Serial Number OM6D61082;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61086(11)240900, Manufacturing Lot/Serial Number OM6D61086;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61092(11)241000, Manufacturing Lot/Serial Number OM6D61092;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61049(11)231000, Manufacturing Lot/Serial Number OM6C61049;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6B61002(11)220800, Manufacturing Lot/Serial Number OM6B61002;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61046(11)231000, Manufacturing Lot/Serial Number OM6C61046;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61089(11)241000, Manufacturing Lot/Serial Number OM6D61089;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6D61088(11)241000, Manufacturing Lot/Serial Number OM6D61088;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61017(11)230300, Manufacturing Lot/Serial Number OM6C61017;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6C61052(11)231100, Manufacturing Lot/Serial Number OM6C61052;  OMNI PET Gantry 30cm:  UDI (01)00195278454218(21)OM6E61105(11)250520, Manufacturing Lot/Serial Number OM6E61105;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)241017(21)OMW302400002PT, Manufacturing Lot/Serial Number OMW302400002PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250115(21)OMW302500002PT, Manufacturing Lot/Serial Number OMW302500002PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250624(21)OMW302500012PT, Manufacturing Lot/Serial Number OMW302500012PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250502(21)OMW302500011PT, Manufacturing Lot/Serial Number OMW302500011PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250625(21)OMW302500013PT, Manufacturing Lot/Serial Number OMW302500013PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250417(21)OMW302500008PT, Manufacturing Lot/Serial Number OMW302500008PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250425(21)OMW302500010PT, Manufacturing Lot/Serial Number OMW302500010PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250423(21)OMW302500009PT, Manufacturing Lot/Serial Number OMW302500009PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)241202(21)OMW302400004PT, Manufacturing Lot/Serial Number OMW302400004PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250331(21)OMW302500007PT, Manufacturing Lot/Serial Number OMW302500007PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)241104(21)OMW302400003PT, Manufacturing Lot/Serial Number OMW302400003PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250210(21)OMW302500003PT, Manufacturing Lot/Serial Number OMW302500003PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250110(21)OMW302500001PT, Manufacturing Lot/Serial Number OMW302500001PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250323(21)OMW302500006PT, Manufacturing Lot/Serial Number OMW302500006PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250306(21)OMW302500004PT, Manufacturing Lot/Serial Number OMW302500004PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)241002(21)OMW302400001PT, Manufacturing Lot/Serial Number OMW302400001PT;  Omni PET Gantry 30cm - WSO:  UDI (01)00195278901439(11)250317(21)OMW302500005PT, Manufacturing Lot/Serial Number OMW302500005PT.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1112-2026%22", "url": "https://recallledger.net/recalls/device-z-1112-2026-ge-healthcare-omni-legend-sold-under-the-following-names-omni-leg/"}, {"id": "fda-device-z-1111-2026", "source": "FDA", "category": "device", "recall_number": "Z-1111-2026", "title": "Tego Connector: REF: 011-D1000 recall (ICU Medical, Inc.)", "product": "Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000", "reason": "Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted   therapy, exposure to biological contaminants, air infused into the body", "hazard_level": "Class II", "company": "ICU Medical, Inc.", "company_location": "San Clemente, CA, United States", "date": "2025-12-19", "report_date": "2026-01-28", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of FL, AZ, RI, TN, KS, NJ, NY, VA, SC, GA, CA, MS, TX, OH, NC, MA, WA, IL, PA, NV, NH, LA, MI, NE, ME, MN, NM, OK, MD, IA, OR, SD, WI, MO, AL, WY, IN, KY, DC, UT, AR, WV, AK, ND, CO and the countries of BE, DE, CO, ES, AU, AR, SA, SI, IT, LK, MY, AT, FI, GB, TW, MX, NL, IE, CA, GR, ZA, SE, SK, NZ, LT, CH, HR, FR, JO, PE, SG, BR, PL, RO, HU, CZ, NO, AE, EE, CN, MA, HK.", "states": ["AK", "AL", "AR", "AZ", "CA", "CO", "DC", "DE", "FL", "GA", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "ND", "NE", "NH", "NJ", "NM", "NV", "NY", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV", "WY"], "nationwide": true, "quantity": "14,684,607 items", "codes": "UDI-DI: 00840619026059, 00840619006785.  REF/Lot(Expiration): 011-D1000/14015455(5/1/2029), 14044313(6/1/2029), 14228823(12/1/2029), 14274294(1/1/2030);  01C-D1000/14171414(10/1/2029), 14304670(2/1/2030);  055-D1000/13772668(9/1/2028), 13778926(9/1/2028), 13791786(10/1/2028), 13794986(10/1/2028), 13797963(10/1/2028), 13801102(10/1/2028), 13806764(10/1/2028), 13812991(11/1/2028), 13822705(11/1/2028), 13828556(11/1/2028), 13833879(11/1/2028), 13838937(12/1/2028), 13867515(1/1/2029), 13875052(1/1/2029), 13876502(1/1/2029), 13876503(1/1/2029), 13882254(1/1/2029), 13882256(1/1/2029), 13887995(1/1/2029), 13887996(1/1/2029), 13894349(2/1/2029), 13894350(2/1/2029), 13903971(2/1/2029), 13903972(2/1/2029), 14045054(6/1/2029), 14045055(6/1/2029), 14049379(6/1/2029), 14049404(6/1/2029), 14063784(6/1/2029), 14063785(6/1/2029), 14071890(7/1/2029), 14071891(7/1/2029), 14071892(7/1/2029), 14087320(7/1/2029), 14090798(7/1/2029), 14110500(8/1/2029), 14131560(8/1/2029), 14144999(9/1/2029), 14145000(9/1/2029), 14150873(9/1/2029), 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"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2026%22", "url": "https://recallledger.net/recalls/device-z-1111-2026-tego-connector-ref-011-d1000-01c-d1000-055-d1000-d1000-conector/"}, {"id": "fda-food-h-0403-2026", "source": "FDA", "category": "food", "recall_number": "H-0403-2026", "title": "Brussel Sprouts & Kale Slaw recall (WFM Purchasing, LP)", "product": "Brussel Sprouts & Kale Slaw", "reason": "Undeclared Fish and Egg Allergen", "hazard_level": "Class I", "company": "WFM Purchasing, LP", "company_location": "Austin, TX, United States", "date": "2025-12-31", "report_date": "2026-01-21", "status": "Terminated", "distribution": "New York, New Jersey and Virginia", "states": ["NJ", "NY", "VA"], "nationwide": false, "quantity": "88 units", "codes": "No code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0403-2026%22", "url": "https://recallledger.net/recalls/food-h-0403-2026-brussel-sprouts-kale-slaw/"}, {"id": "fda-food-h-0402-2026", "source": "FDA", "category": "food", "recall_number": "H-0402-2026", "title": "Atwater's recall (One Roof LLC)", "product": "Atwater's, Holiday Cookie Tin, 19.65 ounces, Round metal tin with a window lid", "reason": "Undeclared tree nut allergens: almonds, pecans, and walnuts.", "hazard_level": "Class I", "company": "One Roof LLC", "company_location": "Baltimore, MD, United States", "date": "2025-12-21", "report_date": "2026-01-21", "status": "Terminated", "distribution": "The recall product was distributed to the following state: MD", "states": ["MD"], "nationwide": false, "quantity": "197 cookie tin containers", "codes": "no code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0402-2026%22", "url": "https://recallledger.net/recalls/food-h-0402-2026-atwater-s-holiday-cookie-tin-19-65-ounces-round-metal-tin-with-a-wi/"}, {"id": "fda-food-h-0401-2026", "source": "FDA", "category": "food", "recall_number": "H-0401-2026", "title": "Jumbo RAW SHRIMP recall (AZ Gems, Inc.)", "product": "Jumbo RAW SHRIMP, All Natural, Chemical Free, No artificial ingredients, NET WT. 32 OZ (2 LB) 907g UPC: 1 93968 00697 6", "reason": "elevated levels of chloramphenicol in frozen shrimp", "hazard_level": "Class II", "company": "AZ Gems, Inc.", "company_location": "Redlands, CA, United States", "date": "2025-12-04", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Product was shipped nationwide and distributed exclusively under the Member's Mark label.", "states": [], "nationwide": true, "quantity": "1099 cases", "codes": "Product Codes: 231874 4D20 & 231874 4D21 Best By: 4/19/2026 & 4/20/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0401-2026%22", "url": "https://recallledger.net/recalls/food-h-0401-2026-jumbo-raw-shrimp-all-natural-chemical-free-no-artificial-ingredient/"}, {"id": "fda-food-h-0400-2026", "source": "FDA", "category": "food", "recall_number": "H-0400-2026", "title": "Troemner Family Farm Pfeffernusse Cookies recall (Troemner Farm)", "product": "Troemner Family Farm Pfeffernusse Cookies, 6oz and 12oz bags", "reason": "undeclared soy, wheat, milk", "hazard_level": "Class I", "company": "Troemner Farm", "company_location": "Atlantic Mine, MI, United States", "date": "2025-12-19", "report_date": "2026-01-21", "status": "Terminated", "distribution": "MI", "states": ["MI"], "nationwide": false, "quantity": "56 retail units", "codes": "product does not have lot or best by code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0400-2026%22", "url": "https://recallledger.net/recalls/food-h-0400-2026-troemner-family-farm-pfeffernusse-cookies-6oz-and-12oz-bags/"}, {"id": "fda-food-h-0399-2026", "source": "FDA", "category": "food", "recall_number": "H-0399-2026", "title": "Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based recall (Fran's Chocolates Ltd)", "product": "Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based, net wt. 1.1oz, UPC 7 49668 24280 2.    Ingredients: Sugar, cocoa butter, cocoa beans, almonds, sunflower lecithin, vanilla extract. May contain traces of milk, peanuts and sesame. Fran's Chocolates, Ltd. Seattle, WA 98108.", "reason": "undeclared hazelnut.", "hazard_level": "Class I", "company": "Fran's Chocolates Ltd", "company_location": "Seattle, WA, United States", "date": "2025-12-20", "report_date": "2026-01-21", "status": "Terminated", "distribution": "Distributed in CO, MA, NV, WA and online at www.frans.com", "states": ["CO", "MA", "NV", "WA"], "nationwide": false, "quantity": "112 units", "codes": "None", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0399-2026%22", "url": "https://recallledger.net/recalls/food-h-0399-2026-fran-s-purebar-almondmilk-chocolate-46-madagascar-plant-based-net-wt/"}, {"id": "fda-food-h-0398-2026", "source": "FDA", "category": "food", "recall_number": "H-0398-2026", "title": "So Delicious Dairy Free Salted Caramel Cluster Cashewmilk recall (WhiteWave - Louisville Pilot Plant)", "product": "So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured By/For So Delicious Dairy Free Eugene, OR 97402  So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. Net wt. 500mL. UPC 744473 276134. Product of the U.S.A. Distributed by Danone Inc., Boucherville, Quebec J4B 1E6", "reason": "Foreign material", "hazard_level": "Class II", "company": "WhiteWave - Louisville Pilot Plant", "company_location": "Louisville, CO, United States", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Terminated", "distribution": "Distributed in the U.S. nationwide and in Canada.", "states": [], "nationwide": true, "quantity": "4,665,608 units distributed in the US; 665,128 units distributed in Canada", "codes": "***In the US*** All Best By dates from 11 DEC 2025 and before 8 AUG 2027  S05-33 25218 20:05  S05-33 is the Plant Code, 25 is the Year, 218 is the Julian Date, 20:05 is the Time of fill.  ***In Canada*** BB: 14 Feb 2026 BB: 13 Apr 2026  BB: 14 May 2026  BB: 4 Jun 2026  BB: 31 Jul 2026 BB: 13 Aug 2026  BB: 2 Jan 2027  BB: 3 Jan 2027  BB: 4 Jan 202,  BB: 19 Jun 2027  BB: 20 Jun 2027 BB: 21 Jun 2027  BB: 9 Jul 2027 BB: 10 Jul 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0398-2026%22", "url": "https://recallledger.net/recalls/food-h-0398-2026-so-delicious-dairy-free-salted-caramel-cluster-cashewmilk-non-dairy-f/"}, {"id": "fda-food-h-0397-2026", "source": "FDA", "category": "food", "recall_number": "H-0397-2026", "title": "Ukrop's 6\" Pound Cake with Buttercream Icing/Red Roses recall (Ukrop's Homestyle Foods, LLC)", "product": "Ukrop's 6\" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8\" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. Ukrop's Homestyle Foods, LLC Richmond, VA 23230", "reason": "Undeclared Soy. Label did not include soy, which was used in product.", "hazard_level": "Class II", "company": "Ukrop's Homestyle Foods, LLC", "company_location": "Richmond, VA, United States", "date": "2025-12-11", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Product was shipped to VA & WV.", "states": ["VA", "WV"], "nationwide": false, "quantity": "61 cakes (total)", "codes": "BEST BY 12/15/25", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0397-2026%22", "url": "https://recallledger.net/recalls/food-h-0397-2026-ukrop-s-6-pound-cake-with-buttercream-icing-red-roses-net-wt-30-oz-2/"}, {"id": "fda-food-h-0396-2026", "source": "FDA", "category": "food", "recall_number": "H-0396-2026", "title": "Ukrop's 6\" Pound Cake with Buttercream Icing/Pink Roses recall (Ukrop's Homestyle Foods, LLC)", "product": "Ukrop's 6\" Pound Cake with Buttercream Icing/Pink Roses NET WT 44 OZ (2.75lb/1.25kg) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91452 7 Ukrop's Homestyle Foods, LLC Richmond, VA 23230", "reason": "Undeclared Soy. Label did not include soy, which was used in product.", "hazard_level": "Class II", "company": "Ukrop's Homestyle Foods, LLC", "company_location": "Richmond, VA, United States", "date": "2025-12-11", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Product was shipped to VA & WV.", "states": ["VA", "WV"], "nationwide": false, "quantity": "61 cakes (total)", "codes": "BEST BY 12/15/25", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0396-2026%22", "url": "https://recallledger.net/recalls/food-h-0396-2026-ukrop-s-6-pound-cake-with-buttercream-icing-pink-roses-net-wt-44-oz/"}, {"id": "fda-food-h-0395-2026", "source": "FDA", "category": "food", "recall_number": "H-0395-2026", "title": "Ukrop's 6\" Pound Cake with Buttercream Icing/Confetti recall (Ukrop's Homestyle Foods, LLC)", "product": "Ukrop's 6\" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91849 5 Ukrop's Homestyle Foods, LLC Richmond, VA 23", "reason": "Undeclared Soy. Label did not include soy, which was used in product.", "hazard_level": "Class II", "company": "Ukrop's Homestyle Foods, LLC", "company_location": "Richmond, VA, United States", "date": "2025-12-11", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Product was shipped to VA & WV.", "states": ["VA", "WV"], "nationwide": false, "quantity": "61 cakes (total)", "codes": "BEST BY 12/15/25", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0395-2026%22", "url": "https://recallledger.net/recalls/food-h-0395-2026-ukrop-s-6-pound-cake-with-buttercream-icing-confetti-net-wt-30-oz-1/"}, {"id": "fda-food-h-0393-2026", "source": "FDA", "category": "food", "recall_number": "H-0393-2026", "title": "Healthy Truth brand Moringa Powder recall (Organic Living Superfoods Llc)", "product": "Healthy Truth brand Moringa Powder; 5lb and 20lb", "reason": "Products may be contaminated with Salmonella Richmond.", "hazard_level": "Class I", "company": "Organic Living Superfoods Llc", "company_location": "Walpole, MA, United States", "date": "2025-12-04", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "MD, NC, WA, CT, PA", "states": ["CT", "MD", "NC", "PA", "WA"], "nationwide": false, "quantity": "88 lbs", "codes": "TBD", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0393-2026%22", "url": "https://recallledger.net/recalls/food-h-0393-2026-healthy-truth-brand-moringa-powder-5lb-and-20lb/"}, {"id": "fda-food-h-0385-2026", "source": "FDA", "category": "food", "recall_number": "H-0385-2026", "title": "Publix Rice & Pigeon Peas recall (ASK Foods Inc)", "product": "Publix Rice & Pigeon Peas, Net Wt 32 oz (2lb), Plastic tray with clear lid, black film, and a pre-printed label. 6 (2lb) containers per case .", "reason": "Undeclared Allergen (Soy)", "hazard_level": "Class III", "company": "ASK Foods Inc", "company_location": "Palmyra, PA, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Terminated", "distribution": "The adulterated product was distributed to one state, FL", "states": ["FL"], "nationwide": false, "quantity": "2078 units in total", "codes": "5387-4, 5387-5, & 5387-6", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0385-2026%22", "url": "https://recallledger.net/recalls/food-h-0385-2026-publix-rice-pigeon-peas-net-wt-32-oz-2lb-plastic-tray-with-clear/"}, {"id": "fda-food-h-0384-2026", "source": "FDA", "category": "food", "recall_number": "H-0384-2026", "title": "1972 Banana Pudding Ice Cream recall (House Of Flavors, Inc.)", "product": "1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6", "reason": "Undeclared soy lecithin", "hazard_level": "Class II", "company": "House Of Flavors, Inc.", "company_location": "Ludington, MI, United States", "date": "2025-12-12", "report_date": "2026-01-21", "status": "Completed", "distribution": "AL AZ CT GA IA IL IN KY MI MN MO NC NJ NY OH TN TX VA", "states": ["AL", "AZ", "CT", "GA", "IA", "IL", "IN", "KY", "MI", "MN", "MO", "NC", "NJ", "NY", "OH", "TN", "TX", "VA"], "nationwide": false, "quantity": "2,388 units", "codes": "Lot numbers: 22236, 23175, 24019, 24051, 25070, 25247", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0384-2026%22", "url": "https://recallledger.net/recalls/food-h-0384-2026-1972-banana-pudding-ice-cream-3-gal-upc-0-75196-00556-6/"}, {"id": "fda-food-h-0383-2026", "source": "FDA", "category": "food", "recall_number": "H-0383-2026", "title": "2248 Banana Pudding Ice Cream recall (House Of Flavors, Inc.)", "product": "2248 Banana Pudding Ice Cream, 3 GAL, UPC 7 65265 81237 8", "reason": "Undeclared soy lecithin", "hazard_level": "Class II", "company": "House Of Flavors, Inc.", "company_location": "Ludington, MI, United States", "date": "2025-12-12", "report_date": "2026-01-21", "status": "Completed", "distribution": "AL AZ CT GA IA IL IN KY MI MN MO NC NJ NY OH TN TX VA", "states": ["AL", "AZ", "CT", "GA", "IA", "IL", "IN", "KY", "MI", "MN", "MO", "NC", "NJ", "NY", "OH", "TN", "TX", "VA"], "nationwide": false, "quantity": "34,561 units", "codes": "Lot numbers: 23222, 23283, 24019, 24051, 24248, 25070, 25247", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0383-2026%22", "url": "https://recallledger.net/recalls/food-h-0383-2026-2248-banana-pudding-ice-cream-3-gal-upc-7-65265-81237-8/"}, {"id": "fda-drug-d-0287-2026", "source": "FDA", "category": "drug", "recall_number": "D-0287-2026", "title": "Toothpaste: a) COLGATE recall (GOLD STAR DISTRIBUTION INC)", "product": "Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0287-2026%22", "url": "https://recallledger.net/recalls/drug-d-0287-2026-toothpaste-a-colgate-toothpaste-whitening-2-5oz-24ct-upc-03500/"}, {"id": "fda-drug-d-0286-2026", "source": "FDA", "category": "drug", "recall_number": "D-0286-2026", "title": "Deodorant: a) Axe recall (GOLD STAR DISTRIBUTION INC)", "product": "Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY  DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2026%22", "url": "https://recallledger.net/recalls/drug-d-0286-2026-deodorant-a-axe-body-spray-wild-spice-6ct-150ml-upc-6001087364/"}, {"id": "fda-drug-d-0285-2026", "source": "FDA", "category": "drug", "recall_number": "D-0285-2026", "title": "Petroleum jelly: a) Vaseline Petroleum Jelly recall (GOLD STAR DISTRIBUTION INC)", "product": "Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0285-2026%22", "url": "https://recallledger.net/recalls/drug-d-0285-2026-petroleum-jelly-a-vaseline-petroleum-jelly-1-75-12ct-upc-6001085/"}, {"id": "fda-drug-d-0284-2026", "source": "FDA", "category": "drug", "recall_number": "D-0284-2026", "title": "LUCKY ICE recall (GOLD STAR DISTRIBUTION INC)", "product": "LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0284-2026%22", "url": "https://recallledger.net/recalls/drug-d-0284-2026-lucky-ice-cool-mouthwash-alcohol-free-16-9oz-12ct-upc-8088291089/"}, {"id": "fda-drug-d-0283-2026", "source": "FDA", "category": "drug", "recall_number": "D-0283-2026", "title": "Personal Care recall (GOLD STAR DISTRIBUTION INC)", "product": "Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0283-2026%22", "url": "https://recallledger.net/recalls/drug-d-0283-2026-personal-care-vaporizing-chest-rub-4-oz-12-count-upc-048155903319/"}, {"id": "fda-drug-d-0282-2026", "source": "FDA", "category": "drug", "recall_number": "D-0282-2026", "title": "Carmex a) jar recall (GOLD STAR DISTRIBUTION INC)", "product": "Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0282-2026%22", "url": "https://recallledger.net/recalls/drug-d-0282-2026-carmex-a-jar-12-count-upc-083078123154-083078113155-b-tube-peg/"}, {"id": "fda-drug-d-0281-2026", "source": "FDA", "category": "drug", "recall_number": "D-0281-2026", "title": "Personal Care recall (GOLD STAR DISTRIBUTION INC)", "product": "Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0281-2026%22", "url": "https://recallledger.net/recalls/drug-d-0281-2026-personal-care-ice-gel-8oz-12-count-upc-048155903463/"}, {"id": "fda-drug-d-0280-2026", "source": "FDA", "category": "drug", "recall_number": "D-0280-2026", "title": "Swan recall (GOLD STAR DISTRIBUTION INC)", "product": "Swan, White Clear Alcohol, 50%, 16oz, 12 count", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0280-2026%22", "url": "https://recallledger.net/recalls/drug-d-0280-2026-swan-white-clear-alcohol-50-16oz-12-count/"}, {"id": "fda-drug-d-0279-2026", "source": "FDA", "category": "drug", "recall_number": "D-0279-2026", "title": "TUMS a) Assorted recall (GOLD STAR DISTRIBUTION INC)", "product": "TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0279-2026%22", "url": "https://recallledger.net/recalls/drug-d-0279-2026-tums-a-assorted-12-ct-b-extra-strength-ex-assorted-berries-12/"}, {"id": "fda-drug-d-0278-2026", "source": "FDA", "category": "drug", "recall_number": "D-0278-2026", "title": "Halls Cough Drops a) BAGS recall (GOLD STAR DISTRIBUTION INC)", "product": "Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0278-2026%22", "url": "https://recallledger.net/recalls/drug-d-0278-2026-halls-cough-drops-a-bags-menthol-12ct-b-bags-honey-lem-12ct-c/"}, {"id": "fda-drug-d-0277-2026", "source": "FDA", "category": "drug", "recall_number": "D-0277-2026", "title": "TYLENOL a) 500 MG. recall (GOLD STAR DISTRIBUTION INC)", "product": "TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0277-2026%22", "url": "https://recallledger.net/recalls/drug-d-0277-2026-tylenol-a-500-mg-2-s-display-50ct-b-cold-flu-25ct-2s-c-cold/"}, {"id": "fda-drug-d-0276-2026", "source": "FDA", "category": "drug", "recall_number": "D-0276-2026", "title": "PEPCID COMPLETE - 25CT recall (GOLD STAR DISTRIBUTION INC)", "product": "PEPCID COMPLETE - 25CT", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0276-2026%22", "url": "https://recallledger.net/recalls/drug-d-0276-2026-pepcid-complete-25ct/"}, {"id": "fda-drug-d-0275-2026", "source": "FDA", "category": "drug", "recall_number": "D-0275-2026", "title": "PEPTO BISMOL 32CT recall (GOLD STAR DISTRIBUTION INC)", "product": "PEPTO BISMOL 32CT", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0275-2026%22", "url": "https://recallledger.net/recalls/drug-d-0275-2026-pepto-bismol-32ct/"}, {"id": "fda-drug-d-0274-2026", "source": "FDA", "category": "drug", "recall_number": "D-0274-2026", "title": "CHILDREN NYQUIL recall (GOLD STAR DISTRIBUTION INC)", "product": "CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0274-2026%22", "url": "https://recallledger.net/recalls/drug-d-0274-2026-children-nyquil-cold-flu-berry-8oz-12ct/"}, {"id": "fda-drug-d-0273-2026", "source": "FDA", "category": "drug", "recall_number": "D-0273-2026", "title": "NYQUIL COLD & FLU -32CT/2PK recall (GOLD STAR DISTRIBUTION INC)", "product": "NYQUIL COLD & FLU -32CT/2PK", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR 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null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0268-2026%22", "url": "https://recallledger.net/recalls/drug-d-0268-2026-liquid-dayquil-12-8oz/"}, {"id": "fda-drug-d-0267-2026", "source": "FDA", "category": "drug", "recall_number": "D-0267-2026", "title": "DAYQUIL COLD & FLU recall (GOLD STAR DISTRIBUTION INC)", "product": "DAYQUIL COLD & FLU, 32CT/2PK", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0267-2026%22", "url": "https://recallledger.net/recalls/drug-d-0267-2026-dayquil-cold-flu-32ct-2pk/"}, {"id": "fda-drug-d-0266-2026", "source": "FDA", "category": "drug", "recall_number": "D-0266-2026", "title": "Claritin recall (GOLD STAR DISTRIBUTION INC)", "product": "Claritin, 20 Count, UPC: 655708016305", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0266-2026%22", "url": "https://recallledger.net/recalls/drug-d-0266-2026-claritin-20-count-upc-655708016305/"}, {"id": "fda-drug-d-0265-2026", "source": "FDA", "category": "drug", "recall_number": "D-0265-2026", "title": "Bayer 2Pk- 25 CT recall (GOLD STAR DISTRIBUTION INC)", "product": "Bayer 2Pk- 25 CT", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2026%22", "url": "https://recallledger.net/recalls/drug-d-0265-2026-bayer-2pk-25-ct/"}, {"id": "fda-drug-d-0264-2026", "source": "FDA", "category": "drug", "recall_number": "D-0264-2026", "title": "Benadryl recall (GOLD STAR DISTRIBUTION INC)", "product": "Benadryl, 25'S 2PK Box, UPC 815556020316", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0264-2026%22", "url": "https://recallledger.net/recalls/drug-d-0264-2026-benadryl-25-s-2pk-box-upc-815556020316/"}, {"id": "fda-drug-d-0263-2026", "source": "FDA", "category": "drug", "recall_number": "D-0263-2026", "title": "Alka Seltzer recall (GOLD STAR DISTRIBUTION INC)", "product": "Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet  in 36 count box, UPC: 016500594932", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unknown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2026%22", "url": "https://recallledger.net/recalls/drug-d-0263-2026-alka-seltzer-a-original-2-tablets-per-packet-in-58-count-box-upc/"}, {"id": "fda-drug-d-0262-2026", "source": "FDA", "category": "drug", "recall_number": "D-0262-2026", "title": "Aleve 1's recall (GOLD STAR DISTRIBUTION INC)", "product": "Aleve 1's, 60 CT", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0262-2026%22", "url": "https://recallledger.net/recalls/drug-d-0262-2026-aleve-1-s-60-ct/"}, {"id": "fda-drug-d-0261-2026", "source": "FDA", "category": "drug", "recall_number": "D-0261-2026", "title": "Advil a) Ibuprofen recall (GOLD STAR DISTRIBUTION INC)", "product": "Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559", "reason": "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.", "hazard_level": "Class II", "company": "GOLD STAR DISTRIBUTION INC", "company_location": "Minneapolis, MN, United States", "date": "2025-12-26", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "Unkown", "codes": "All lots within expiry distributed by Gold Star Distribution.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0261-2026%22", "url": "https://recallledger.net/recalls/drug-d-0261-2026-advil-a-ibuprofen-dispenser-pack-2-tablet-packets-in-box-containing/"}, {"id": "fda-drug-d-0259-2026", "source": "FDA", "category": "drug", "recall_number": "D-0259-2026", "title": "Levothyroxine Sodium Tablets recall (Alvogen, Inc)", "product": "Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.", "reason": "Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.", "hazard_level": "Class II", "company": "Alvogen, Inc", "company_location": "Morristown, NJ, United States", "date": "2025-12-31", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide.", "states": [], "nationwide": true, "quantity": "", "codes": "Lot # MHA21825, Exp Date: December 31, 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0259-2026%22", "url": "https://recallledger.net/recalls/drug-d-0259-2026-levothyroxine-sodium-tablets-usp-thyro-tabs-150mcg-1000-tablets-r/"}, {"id": "fda-drug-d-0256-2026", "source": "FDA", "category": "drug", "recall_number": "D-0256-2026", "title": "Fluocinolone Acetonide Solution Topical Solution USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)", "product": "Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4", "reason": "Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.", "hazard_level": "Class III", "company": "SUN PHARMACEUTICAL INDUSTRIES INC", "company_location": "Princeton, NJ, United States", "date": "2025-12-30", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Nationwide within the USA", "states": [], "nationwide": true, "quantity": "24,624 bottles", "codes": "Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0256-2026%22", "url": "https://recallledger.net/recalls/drug-d-0256-2026-fluocinolone-acetonide-solution-topical-solution-usp-0-01-60-ml-bot/"}, {"id": "fda-device-z-1101-2026", "source": "FDA", "category": "device", "recall_number": "Z-1101-2026", "title": "Portex Spinal Tray recall (ICU Medical Inc.)", "product": "Portex Spinal Tray, Item No. A3729-24  A3595", "reason": "Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.", "hazard_level": "Class II", "company": "ICU Medical Inc.", "company_location": "Minneapolis, MN, United States", "date": "2025-12-19", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH,  OK, TX, WA.", "states": ["CA", "FL", "IL", "IN", "MA", "MI", "MN", "MO", "NE", "NJ", "NY", "OH", "OK", "TX", "WA"], "nationwide": true, "quantity": "64290 total", "codes": "1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed \"-LSM\" suffix.  2. A3595 UDI-DI 35019517108211 Lot 6157980", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2026%22", "url": "https://recallledger.net/recalls/device-z-1101-2026-portex-spinal-tray-item-no-a3729-24-a3595/"}, {"id": "fda-device-z-1100-2026", "source": "FDA", "category": "device", "recall_number": "Z-1100-2026", "title": "Pulsator Arterial Blood Sampling Kit recall (ICU Medical Inc.)", "product": "Pulsator Arterial Blood Sampling Kit, Item Numbers   4044EG-1  4080P-2  4084P-1  4080PE  4080PG", "reason": "Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.", "hazard_level": "Class II", "company": "ICU Medical Inc.", "company_location": "Minneapolis, MN, United States", "date": "2025-12-19", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH,  OK, TX, WA.", "states": ["CA", "FL", "IL", "IN", "MA", "MI", "MN", "MO", "NE", "NJ", "NY", "OH", "OK", "TX", "WA"], "nationwide": true, "quantity": "64290 total", "codes": "1. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228   2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906  3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed \"-LSM\" suffix)  4. 4080PE UDI-DI 30351688039150 Lot 6131839  5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2026%22", "url": "https://recallledger.net/recalls/device-z-1100-2026-pulsator-arterial-blood-sampling-kit-item-numbers-4044eg-1-4080p-2/"}, {"id": "fda-device-z-1098-2026", "source": "FDA", "category": "device", "recall_number": "Z-1098-2026", "title": "Abre Venous Self-Expanding Stent System recall (Medtronic Inc)", "product": "Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090  AB9G12100090  AB9G14080090  AB9G12080090  AB9U12060090  AB9U14100090  AB9U14080090  AB9U12080090  AB9U14060090  AB9G14100090  AB9G12060090", "reason": "Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.", "hazard_level": "Class II", "company": "Medtronic Inc", "company_location": "Plymouth, MN, United States", "date": "2025-12-04", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan,  Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain,  Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.", "states": [], "nationwide": true, "quantity": "442", "codes": "UDI-DI (GTIN):  00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257  Serial/Lot numbers  C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2026%22", "url": "https://recallledger.net/recalls/device-z-1098-2026-abre-venous-self-expanding-stent-system-model-numbers-ab9g14120090-a/"}, {"id": "fda-device-z-1096-2026", "source": "FDA", "category": "device", "recall_number": "Z-1096-2026", "title": "da Vinci  SP recall (Intuitive Surgical, Inc.)", "product": "da Vinci  SP, SP Access Port Kit, Large Incision    Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)", "reason": "Access Port System tray may develop cracks  potentially resulting in a sterility breach.", "hazard_level": "Class II", "company": "Intuitive Surgical, Inc.", "company_location": "Sunnyvale, CA, United States", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.", "states": ["AL", "AZ", "CA", "CO", "CT", "FL", "GA", "IA", "IL", "IN", "KS", "KY", "LA", "MA", "MD", "ME", "MI", "MN", "MO", "MS", "NC", "NH", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "SD", "TN", "TX", "UT", "VA", "WA", "WI", "WV"], "nationwide": true, "quantity": "41,526 units", "codes": "REF: 430073 UDI:  00886874119549 Lot Numbers: U80240110 K10250114 K10250305 K10250306 K10250313 K10250414 K10250424 K10250514 K10250522 K10250619 K10250626 K10250629 K10250630 K10250710 K10250716 K10250717 K10250731 K10250804 K10250806 K10250828 K10250904 K11250113 K11250807 K11250821 K11250828 K11250911 K12250821 U10241101 U10241115 U10250108 U10250207 U10250210 U10250307 U10250310 U10250313 U10250321 U10250325 U10250331 U10250414 U10250425 U10250506 U10250509 U10250521 U10250528 U10250604 U11241101 U11241121 U11241210 U11250123 U11250219 U11250404 U11250425 U11250521 U12250219 U80231207 U80231219 U80240118 U80240125 U80240201 U80240222 U80240306 U80240319 U80240402 U80240411 U80240417 U80240523 U80240617 U80240620 U80240806 U80240812 U80240905 U80240911 U80241017 U80241025 U81231219 U81240118 U81240125 U81240306 U81240319 U81240402 U81240411 U81240417 U81240617 U81240620 U81240627 U81240806 U81240905 U81240911 U82231219   REF: 430075 UDI:  00886874119556 Lot Numbers: U81240125 U80240201 U80240222 U80240125 U81240215 U81240208 U80240208 U81240201 U81240229 U80240326 U80240529 U80240229 U81240222 U80240711 U81240606 U80240606 U80240812 U80240731 U80240917 U10241107 U80241003 U10241217 U10250123 U10250305 U10250219 U10250102 K10250313 U10250414 U10250423 K10250529 K10250522 U10250529 K10250701 K10250702 K10250717 K11250814 K10250807 K11250813 K10250605 U80240611 K10250327 U80240425 U10250312 K10250515 K11250515 U10250318 U80240724 U10250115 U10250326 U80240130 U80240627 K10250113 K11250529 K10250723 U80240717 U80240215 U10250501 K10250403 U10250515 K12250904", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2026%22", "url": "https://recallledger.net/recalls/device-z-1096-2026-da-vinci-sp-sp-access-port-kit-large-incision-reference-numbers/"}, {"id": "fda-device-z-1095-2026", "source": "FDA", "category": "device", "recall_number": "Z-1095-2026", "title": "The product is used for the evaluation of the intrinsic coagulation pathway recall (Instrumentation Laboratory)", "product": "The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of  heparin therapy.", "reason": "Potential for microbial contamination.", "hazard_level": "Class II", "company": "Instrumentation Laboratory", "company_location": "Bedford, MA, United States", "date": "2025-12-11", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.", "states": ["CA", "FL", "IL", "MN", "MS", "NE", "OH", "TX", "WI"], "nationwide": true, "quantity": "7,720 units", "codes": "Part Number: 0020006800.  UDI-DI:  08426950078920. Lot Number: N1136730.  Expiration Date 12/31/2025.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1095-2026%22", "url": "https://recallledger.net/recalls/device-z-1095-2026-the-product-is-used-for-the-evaluation-of-the-intrinsic-coagulation-pa/"}, {"id": "fda-device-z-1094-2026", "source": "FDA", "category": "device", "recall_number": "Z-1094-2026", "title": "Plum Duo Infusion System recall (ICU Medical, Inc.)", "product": "Plum Duo Infusion System, List Number 40002-04-01", "reason": "ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.", "hazard_level": "Class II", "company": "ICU Medical, Inc.", "company_location": "Lake Forest, IL, United States", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "423 units", "codes": "UDI-DI: M335400021; Serial Numbers: 50000221 50000294 50000295 50000296 50000298 50000299 50000300 50000303 50000304 50000309 50001663 50001664 50001665 50001666 50001667 50001668 50001669 50001670 50001671 50001672 50001673 50001674 50001675 50001676 50001677 50001678 50001679 50001680 50001681 50001682 50001683 50001684 50001685 50001686 50001687 50001688 50001689 50001690 50001691 50001692 50001693 50001694 50001695 50001696 50001697 50001698 50001699 50001700 50001701 50001702 50001703 50001704 50001705 50001706 50001707 50001708 50001709 50001710 50001711 50001712 50001713 50001714 50001715 50001716 50001717 50001718 50001719 50001720 50001721 50001722 50001723 50001724 50001725 50001726 50001727 50001728 50001729 50001730 50001731 50001732 50001733 50001734 50001735 50001736 50001737 50001738 50001739 50001740 50001741 50001742 50001743 50001744 50001745 50001746 50001747 50001748 50001749 50001750 50001751 50001752 50001753 50001754 50001755 50001756 50001757 50001758 50001759 50001760 50001761 50001762 50001763 50001765 50001766 50001768 50001770 50001771 50001772 50001773 50001774 50001775 50001776 50001777 50001778 50001779 50001780 50001781 50001782 50001783 50001784 50001785 50001786 50001787 50001788 50001789 50001790 50001791 50001792 50001793 50001794 50001795 50001796 50001797 50001798 50001799 50001800 50001801 50001802 50001803 50001804 50001805 50001806 50001807 50001809 50001810 50001811 50001812 50001813 50001814 50001815 50001816 50001817 50001818 50001819 50001820 50001821 50001822 50001823 50001824 50001825 50001826 50001827 50001828 50001829 50001831 50001833 50001834 50001835 50001836 50001837 50001838 50001839 50001840 50001841 50001842 50001843 50001844 50001845 50001846 50001847 50002285 50003548 50003626 50003702 50003703 50003704 50003705 50003706 50003707 50003708 50003709 50003710 50003712 50003713 50003715 50003716 50003717 50003718 50003719 50003720 50003722 50003723 50003725 50003726 50003727 50003728 50003730 50003732 50003733 50003734 50003735 50003736 50003737 50003738 50003740 50003741 50003742 50003743 50003745 50003746 50003747 50003748 50003749 50003751 50003752 50003754 50003755 50003756 50003757 50003758 50003759 50003760 50003761 50003762 50003763 50003764 50003765 50003766 50003767 50003768 50003770 50003771 50003774 50003775 50003776 50003777 50003779 50003784 50003785 50003786 50003787 50003789 50003792 50003793 50003794 50003797 50003798 50003799 50003800 50003801 50003802 50003803 50003804 50003805 50003807 50004219 50004913 50004939 50005129 50005199 50000004 50000005 50000006 50000008 50000009 50000010 50000011 50000012 50000013 50000014 50000015 50000016 50000017 50000018 50000019 50000020 50000021 50000022 50000023 50000024 50000025 50000026 50000027 50000028 50000030 50000031 50000032 50000034 50000035 50000036 50000037 50000038 50000039 50000041 50000042 50000043 50000044 50000045 50000047 50000048 50000049 50000050 50000051 50000052 50000053 50000055 50000056 50000057 50000058 50000059 50000060 50000061 50000063 50000064 50000065 50000066 50000067 50000068 50000069 50000070 50000071 50000072 50000073 50000074 50000075 50000076 50000077 50000078 50000079 50000080 50000081 50000083 50000084 50000085 50000087 50000088 50000089 50000090 50000092 50000093 50000094 50000095 50000096 50000097 50000098 50000099 50000100 50000101 50000104 50000105 50000106 50000107 50000108 50000109 50000110 50000112 50000113 50000114 50000115 50000116 50000117 50000007 50000033 50000046 50000054 50000062 50000082 50000091 50000102 50000103 50000111 50000249 50000273 50000277 50000283 50000306 50000311 50003711 50003714 50003721 50003724 50003729 50003731 50003739 50003744 50003750 50003769 50003772 50003778 50003782 50003783 50003788 50003790 50003791 50003795 50003806 50003808 50003809 50003810 50004066 50004274 50004364 50001764 50001830", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1094-2026%22", "url": "https://recallledger.net/recalls/device-z-1094-2026-plum-duo-infusion-system-list-number-40002-04-01/"}, {"id": "fda-device-z-1093-2026", "source": "FDA", "category": "device", "recall_number": "Z-1093-2026", "title": "ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. recall (Hologic, Inc)", "product": "ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.", "reason": "Fungal contamination of affected lot with Parengyodontium album.", "hazard_level": "Class II", "company": "Hologic, Inc", "company_location": "Marlborough, MA, United States", "date": "2025-12-12", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "3,728 units", "codes": "Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1093-2026%22", "url": "https://recallledger.net/recalls/device-z-1093-2026-thinprep-cytolyt-solution-buffered-cell-wash-solution/"}, {"id": "fda-device-z-1091-2026", "source": "FDA", "category": "device", "recall_number": "Z-1091-2026", "title": "Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models:    1. Azurion 3 M12. Model Numbers: 722063, 722221.     2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280.     3. Azurion 5 M12. Model Number: 722227.     4. Azurion 5 M20. Model Numbers: 722228, 722281.     5. Azurion 7 B12. Model Numbers: 722067, 722225.    6. Azurion 7 B20. Model Numbers: 722068, 722226.     7. Azurion 7 M12. Model Numbers: 722078, 722223.     8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.", "reason": "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-12", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine/United Arab Emirate, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Vietnam, Yemen.", "states": [], "nationwide": true, "quantity": "10,466 units", "codes": "Software Versions: R2.1.10 and R2.2.10.   1. Model Number (UDI): 722063 ((01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)153, (01)00884838085275(21)69, (01)00884838085275(21)154, (01)00884838085275(21)97, (01)00884838085275(21)137, (01)00884838085275(21)116, (01)00884838085275(21)127, (01)00884838085275(21)151, (01)00884838085275(21)148, (01)00884838085275(21)150, (01)00884838085275(21)146, (01)00884838085275(21)149, (01)00884838085275(21)123, (01)00884838085275(21)130, (01)00884838085275(21)143, (01)00884838085275(21)139, (01)00884838085275(21)144, (01)00884838085275(21)145, (01)00884838085275(21)141, (01)00884838085275(21)140, (01)00884838085275(21)135, (01)00884838085275(21)133, (01)00884838085275(21)107, (01)00884838085275(21)120, (01)00884838085275(21)129, (01)00884838085275(21)105, (01)00884838085275(21)110, (01)00884838085275(21)128, (01)00884838085275(21)119, (01)00884838085275(21)113, (01)00884838085275(21)43, (01)00884838085275(21)117, (01)00884838085275(21)115, (01)00884838085275(21)101, (01)00884838085275(21)94, (01)00884838085275(21)106, (01)00884838085275(21)103, (01)00884838085275(21)99, (01)00884838085275(21)102, (01)00884838085275(21)104, (01)00884838085275(21)100, (01)00884838085275(21)80, (01)00884838085275(21)81, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)82, (01)00884838085275(21)87, (01)00884838085275(21)93, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)79, (01)00884838085275(21)83, (01)00884838085275(21)76, (01)00884838085275(21)77, (01)00884838085275(21)78, (01)00884838085275(21)70, (01)00884838085275(21)53, (01)00884838085275(21)72, (01)00884838085275(21)63, (01)00884838085275(21)71, (01)00884838085275(21)73, 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Model Number (UDI): 722064 ((01)00884838085282(21)209, (01)00884838085282(21)238, (01)00884838085282(21)201, (01)00884838085282(21)258, (01)00884838085282(21)261, (01)00884838085282(21)260, (01)00884838085282(21)314, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)267, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)407, (01)00884838085282(21)496, (01)00884838085282(21)425, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)397, (01)00884838085282(21)168, (01)00884838085282(21)514, (01)00884838085282(21)503, (01)00884838085282(21)517, (01)00884838085282(21)515, (01)00884838085282(21)478, (01)00884838085282(21)484, (01)00884838085282(21)511, (01)00884838085282(21)458, (01)00884838085282(21)513, (01)00884838085282(21)505, (01)00884838085282(21)502, (01)00884838085282(21)510, (01)00884838085282(21)508, (01)00884838085282(21)470, (01)00884838085282(21)509, 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Model Number (UDI): 722227 ((01)00884838099227(21)265, (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)276, (01)00884838099227(21)264, (01)00884838099227(21)63, (01)00884838099227(21)238, (01)00884838099227(21)360, (01)00884838099227(21)322, (01)00884838099227(21)336, (01)00884838099227(21)356, (01)00884838099227(21)353, (01)00884838099227(21)342, (01)00884838099227(21)338, (01)00884838099227(21)345, (01)00884838099227(21)344, (01)00884838099227(21)284, (01)00884838099227(21)326, (01)00884838099227(21)362, (01)00884838099227(21)351, (01)00884838099227(21)208, (01)00884838099227(21)340, (01)00884838099227(21)348, (01)00884838099227(21)352, (01)00884838099227(21)306, (01)00884838099227(21)335, (01)00884838099227(21)332, (01)00884838099227(21)350, (01)00884838099227(21)331, (01)00884838099227(21)355, (01)00884838099227(21)330, (01)00884838099227(21)334, (01)00884838099227(21)346, (01)00884838099227(21)333, (01)00884838099227(21)297, (01)00884838099227(21)339, 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Model Number (UDI): 722228 ((01)00884838099234(21)67, (01)00884838099234(21)524, (01)00884838099234(21)49, (01)00884838099234(21)36, (01)00884838099234(21)10, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)403, (01)00884838099234(21)328, (01)00884838099234(21)481, (01)00884838099234(21)373, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)180, (01)00884838099234(21)61, (01)00884838099234(21)273, (01)00884838099234(21)204, (01)00884838099234(21)538, (01)00884838099234(21)679, (01)00884838099234(21)678, (01)00884838099234(21)76, (01)00884838099234(21)502, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)399, (01)00884838099234(21)533, (01)00884838099234(21)211, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)87, 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Model Number (UDI): 722067 ((01)00884838085350(21)221, (01)00884838085350(21)42, (01)00884838085350(21)172, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)250, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)103, (01)00884838085350(21)114, (01)00884838085350(21)225, (01)00884838085350(21)69, (01)00884838085350(21)214, (01)00884838085350(21)41, (01)00884838085350(21)98, (01)00884838085350(21)81, (01)00884838085350(21)123, (01)00884838085350(21)278, (01)00884838085350(21)46, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838085350(21)150, (01)00884838085350(21)163, (01)00884838085350(21)131, (01)00884838085350(21)71, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)244, (01)00884838085350(21)208, (01)00884838085350(21)147, (01)00884838085350(21)104, (01)00884838085350(21)36, (01)00884838085350(21)234, (01)00884838085350(21)141, (01)00884838085350(21)26, (01)00884838085350(21)148, 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Model Number (UDI): 722068 ((01)00884838085367(21)547, (01)00884838085367(21)467, (01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)455, (01)00884838085367(21)494, (01)00884838085367(21)564, (01)00884838085367(21)95, (01)00884838085367(21)440, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838085367(21)64, (01)00884838085367(21)149, (01)00884838085367(21)42, (01)00884838085367(21)153, (01)00884838085367(21)324, (01)00884838085367(21)323, (01)00884838085367(21)320, (01)00884838085367(21)89, (01)00884838085367(21)85, (01)00884838085367(21)109, (01)00884838085367(21)407, (01)00884838085367(21)239, (01)00884838085367(21)505, (01)00884838085367(21)271, (01)00884838085367(21)443, (01)00884838085367(21)104, (01)00884838085367(21)370, (01)00884838085367(21)322, (01)00884838085367(21)136, (01)00884838085367(21)373, (01)00884838085367(21)524, (01)00884838085367(21)308, 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Model Number (UDI): 722078 ((01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)753, (01)00884838085251(21)523, (01)00884838085251(21)840, (01)00884838085251(21)293, (01)00884838085251(21)291, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085251(21)870, (01)00884838085251(21)613, (01)00884838085251(21)598, (01)00884838085251(21)679, (01)00884838085251(21)224, (01)00884838085251(21)829, (01)00884838085251(21)249, (01)00884838085251(21)546, (01)00884838085251(21)478, (01)00884838085251(21)479, (01)00884838085251(21)513, (01)00884838085251(21)278, (01)00884838085251(21)438, (01)00884838085251(21)437, (01)00884838085251(21)456, (01)00884838085251(21)833, (01)00884838085251(21)566, (01)00884838085251(21)488, (01)00884838085251(21)327, (01)00884838085251(21)550, (01)00884838085251(21)571, (01)00884838085251(21)545, (01)00884838085251(21)544, (01)00884838085251(21)465, (01)00884838085251(21)376, (01)00884838085251(21)31, 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Model Number (UDI): 722079 ((01)00884838085268(21)1023, (01)00884838085268(21)645, (01)00884838085268(21)646, (01)00884838085268(21)1013, (01)00884838085268(21)1387, (01)00884838085268(21)460, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)703307, (01)00884838085268(21)703904, (01)00884838085268(21)890, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838085268(21)401, (01)00884838085268(21)1054, (01)00884838085268(21)1010, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)266, (01)00884838085268(21)535, (01)00884838085268(21)818, (01)00884838085268(21)412, (01)00884838085268(21)617, (01)00884838085268(21)246, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838085268(21)905, (01)00884838085268(21)55, (01)00884838085268(21)992, (01)00884838085268(21)691, (01)00884838085268(21)848, (01)00884838085268(21)809, (01)00884838085268(21)1033, 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"Z-1090-2026", "title": "Medline medical procedure convenience kits labeled as:  KIT ROBOTICS UROLOGY PROSTATE recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:  KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "12 units", "codes": "UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1090-2026%22", "url": "https://recallledger.net/recalls/device-z-1090-2026-medline-medical-procedure-convenience-kits-labeled-as-kit-robotics-u/"}, {"id": "fda-device-z-1089-2026", "source": "FDA", "category": "device", "recall_number": "Z-1089-2026", "title": "Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) LAVH PROCEDURE, REF CDS980754T;   2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q;   3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F;   4) LAVH, REF DYNJQ9041R;   5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I;   6) ROBOTIC LAVH, REF DYNJ901281I;   7) LAVH-LF, REF DYNJ901829T;   8) LEX LAP HYST, REF DYNJ902030J;   9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D;   10) GYN LAPAROSCOPY, REF DYNJ905485J;   11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C;   12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634;   13) LAVH GYN/ONC, REF DYNJ910927.", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "1457 units", "codes": "REF CDS980754T:  UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184;  REF CDS982662Q:  UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918;  REF CDS985344F:  UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493;  REF DYNJQ9041R:  UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298;  REF DYNJ900244I:  UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261;  REF DYNJ901281I:  UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191;  REF DYNJ901829T:  UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095;  REF DYNJ902030J:  UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371;  REF DYNJ905274D:  UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700;  REF DYNJ905485J:  UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650;  REF DYNJ906380C:  UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453;  REF DYNJ910634:  UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511;  REF DYNJ910927:  UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1089-2026%22", "url": "https://recallledger.net/recalls/device-z-1089-2026-medline-medical-procedure-convenience-kits-labeled-as-1-lavh-proc/"}, {"id": "fda-device-z-1088-2026", "source": "FDA", "category": "device", "recall_number": "Z-1088-2026", "title": "Medline medical procedure convenience kits labeled as:    1) ROBOTIC recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) ROBOTIC, REF CDS980523M;   2) ROBOTIC GYN, REF CDS980647K;   3) DAVINCI PROCEDURE, REF CDS980864Q;   4) GYN-URO LAPSCP CDS-LF, REF CDS981583U;   5) GYN-URO LAPSCP CDS-LF, REF CDS981583V;   6) GYN ROBOTIC, REF CDS981826K;   7) DEPAUL DAVINCI CDS, REF CDS982377K;   8) GU DAVINCI, REF CDS982779N;   9) GYN DAVINCI, REF CDS982780V;   10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K;   11) ROBOTIC GU/GYN, REF CDS983393L;   12) GYN LAPAROSCOPY CDS, REF CDS984656Q;   13) GYN LAPAROSCOPY CDS, REF CDS984656R;   14) DAVINCI CDS UCC-LF, REF CDS984663J;   15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J;   16) DAVINCI PROSTATECTOMY, REF DYNJG901002B;   17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C;   18) ROBOTIC PACK, REF DYNJ36840L;   19) ROBOTIC PACK MNMC, REF DYNJ38152D;   20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J;   21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P;   22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D;   23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F;   24) GYN ROBOTIC PACK, REF DYNJ52581D;   25) GYN LAPAROSCOPY PACK, REF DYNJ53782J;   26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P;   27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B;   28) GYN LAPAROSCOPY, REF DYNJ62136B;   29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F;   30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B;   31) ROBOTIC PACK, REF DYNJ67177D;   32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B;   33) DAVINCI, REF DYNJ900963M;   34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N;   35) LEX DAVINCI UROLOGY, REF DYNJ900967N;   36) COR DAVINCI, REF DYNJ901018O;   37) GYN ROBOTIC, REF DYNJ901046M;   38) DAVINCI, REF DYNJ901076L;   39) GYN ROBOTIC, REF DYNJ901796K;   40) LOU GENERAL ROBOT, REF DYNJ901844N;   41) LOU GYN LAPAROSCOPY, REF DYNJ901845L;   42) LOU GYN LAPAROSCOPY, REF DYNJ901845M;   43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N;   44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G;   45) GYN ROBOT, REF DYNJ902513J;   46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O;   47) WMC ROBOTIC PACK - LF, REF DYNJ902583N;   48) ROBOTIC GYN & GU, REF DYNJ903459J;   49) GYN LAPAROSCOPY-LF, REF DYNJ903647I;   50) ROBOTIC UROLOGY, REF DYNJ903827F;   51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R;   52) GYN ROBOTIC, REF DYNJ903983P;   53) GYN LAP, REF DYNJ903990Q;   54) ROBOTIC-LF, REF DYNJ904254L;   55) ROBOTIC, REF DYNJ904343G;   56) ROBOT GYN, REF DYNJ904572L;   57) ROBOTIC PROSTECTOMY, REF DYNJ904597G;   58) GYN LAPAROSCOPY-LF, REF DYNJ905289G;   59) GYN ROBOTIC, REF DYNJ905730J;   60) URO ROBOTIC, REF DYNJ905746J;   61) COLON KIT, REF DYNJ905964G;   62) CHN OR ROBOTIC GYN, REF DYNJ905985O;   63) CW ROBOT, REF DYNJ906051C;   64) CW ROBOT, REF DYNJ906051D;   65) ROBOT, REF DYNJ906112B;   66) CDS ROBOTIC GYN CH, REF DYNJ906265D;   67) ROBOTIC GYN PACK, REF DYNJ906265F;   68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F;   69) GYN LAPAROSCOPY, REF DYNJ906357C;   70) ROBOTIC COLON, REF DYNJ906379D;   71) GYN DAVINCI FOAKS, REF DYNJ906444C;   72) DAVINCI, REF DYNJ906543B;   73) CHN GYN ONCOLOGY, REF DYNJ906731K;   74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F;   75) WMC THORACIC ROBOTIC, REF DYNJ907153C;   76) WMC THORACIC ROBOTIC, REF DYNJ907153D;   77) GYN ROBOTIC, REF DYNJ907492F;   78) KIT LAP GYN NTX, REF DYNJ907599C;   79) KIT ROBOTIC GYN, REF DYNJ907635D;   80) KIT ROBOTIC GYN, REF DYNJ907647B;   81) ROBOTIC-LF, REF DYNJ907910F;   82) ROBOTIC GENERAL, REF DYNJ907919C;   83) ROBOTIC BASE, REF DYNJ908447D;   84) ROBOTIC BASE, REF DYNJ908447F;   85) GYN, REF DYNJ908504A;   86) GU DAVINCI KIT, REF DYNJ908783F;   87) ROBOTIC PROSTATE, REF DYNJ909120D;   88) OSC ROBOT BARIATRIC, REF DYNJ909547;   89) LEX DAVINCI PROSTATE, REF DYNJ909548A;   90) GYN-URO ROBOT, REF DYNJ910137A;   91) PROSTATECTOMY ROBOTIC, REF DYNJ910991;   92) GYN ROBOTIC, REF DYNJ910995;   93) ROBOTIC, REF DYNJ9225761X;   94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X;   95) MB GYN ROBOTIC ADD, REF DYNJ9701096M;   96) PHS722500FCK, REF PHS722500G.", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "12584 units", "codes": "REF CDS980523M:  UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036;  REF CDS980523M:  UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218;  REF CDS980647K:  UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829;  REF CDS980647K:  UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860;  REF CDS980864Q:  UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533;  REF CDS981583U:  UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570;  REF CDS981583V:  UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816;  REF CDS981583V:  UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462;  REF CDS981826K:  UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633;  REF CDS981826K:  UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420;  REF CDS982377K:  UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839;  REF CDS982377K:  UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMF861;  REF CDS982377K:  UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25CMC823;  REF CDS982779N:  UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25EBF365;  REF CDS982779N:  UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25CBM352;  REF CDS982780V:  UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25EBI642;  REF CDS982780V:  UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25DBP916;  REF CDS982780V:  UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25CBT429;  REF CDS982857K:  UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25FBR222;  REF CDS982857K:  UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25EBJ713;  REF CDS982857K:  UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25CBH758;  REF CDS983393L:  UDI/DI 10198459224614 (EA) 40198459224615 (CS), Lot number 25EBP657;  REF CDS984656Q:  UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25CMG731;  REF CDS984656Q:  UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25BME966;  REF CDS984656R:  UDI/DI 10198459312113 (EA) 40198459312114 (CS), Lot number 25DMI408;  REF CDS984663J:  UDI/DI 10198459019418 (EA) 40198459019419 (CS), Lot number 25CBM414;  REF CDS985467J:  UDI/DI 10195327689124 (EA) 40195327689125 (CS), Lot number 25BMF759;  REF DYNJG901002B:  UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25FLA112;  REF DYNJG901002B:  UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25ELA210;  REF DYNJVB91075C:  UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA810;  REF DYNJVB91075C:  UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA007;  REF DYNJVB91075C:  UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25DLA059;  REF DYNJ36840L:  UDI/DI 10198459331923 (EA) 40198459331924 (CS), Lot number 25EBB131;  REF DYNJ38152D:  UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25FLA334;  REF DYNJ38152D:  UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25DLA454;  REF DYNJ38152D:  UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25CLA543;  REF DYNJ50649J:  UDI/DI 10195327261504 (EA) 40195327261505 (CS), Lot number 25CBT190;  REF DYNJ52096P:  UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25FDA204;  REF DYNJ52096P:  UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25DDB877;  REF DYNJ52564D:  UDI/DI 10195327176426 (EA) 40195327176427 (CS), Lot number 25BMF583;  REF DYNJ52564F:  UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMD560;  REF DYNJ52564F:  UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMI642;  REF DYNJ52581D:  UDI/DI 10195327213886 (EA) 40195327213887 (CS), Lot number 25DMB242;  REF DYNJ53782J:  UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25EMI041;  REF DYNJ53782J:  UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25DMG684;  REF DYNJ53782J:  UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25CMD347;  REF DYNJ53968P:  UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25FMD297;  REF DYNJ53968P:  UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMH371;  REF DYNJ53968P:  UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMA836;  REF DYNJ53968P:  UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMH615;  REF DYNJ53968P:  UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMA935;  REF DYNJ57458B:  UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25FBD162;  REF DYNJ57458B:  UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBV003;  REF DYNJ57458B:  UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBO450;  REF DYNJ57458B:  UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBB005;  REF DYNJ62136B:  UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBS192;  REF DYNJ62136B:  UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBB252;  REF DYNJ62136B:  UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBU301;  REF DYNJ62136B:  UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBB429;  REF DYNJ63392F:  UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25FLA272;  REF DYNJ63392F:  UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25ELA626;  REF DYNJ63392F:  UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25DLA944;  REF DYNJ63456B:  UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25FBO125;  REF DYNJ63456B:  UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25DBK731;  REF DYNJ67177D:  UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD264;  REF DYNJ67177D:  UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD519;  REF DYNJ67177D:  UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25EBE408;  REF DYNJ67177D:  UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25DBC173;  REF DYNJ84433B:  UDI/DI 10198459113598 (EA) 40198459113599 (CS), Lot number 25EBD020;  REF DYNJ900963M:  UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25FBC396;  REF DYNJ900963M:  UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25DBC417;  REF DYNJ900963M:  UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25BBU398;  REF DYNJ900965N:  UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25FBN962;  REF DYNJ900965N:  UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBP344;  REF DYNJ900965N:  UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBC207;  REF DYNJ900967N:  UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25EBV490;  REF DYNJ900967N:  UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25DBC354;  REF DYNJ901018O:  UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25FBJ418;  REF DYNJ901018O:  UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25EBK336;  REF DYNJ901018O:  UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25DBV042;  REF DYNJ901018O:  UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25CBL781;  REF DYNJ901046M:  UDI/DI 10198459130380 (EA) 40198459130381 (CS), Lot number 25FBM810;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMJ099;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMG577;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD806;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD755;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25DMB047;  REF DYNJ901076L:  UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25CMI669;  REF DYNJ901796K:  UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMI909;  REF DYNJ901796K:  UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EME506;  REF DYNJ901796K:  UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMA622;  REF DYNJ901796K:  UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25CME376;  REF DYNJ901844N:  UDI/DI 10195327620981 (EA) 40195327620982 (CS), Lot number 25DBE209;  REF DYNJ901845L:  UDI/DI 10195327579197 (EA) 40195327579198 (CS), Lot number 25CBC628;  REF DYNJ901845M:  UDI/DI 10198459288159 (EA) 40198459288150 (CS), Lot number 25EBS830;  REF DYNJ901850N:  UDI/DI 10195327620998 (EA) 40195327620999 (CS), Lot number 25DBE377;  REF DYNJ902029G:  UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBR019;  REF DYNJ902029G:  UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBH434;  REF DYNJ902029G:  UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25CBO260;  REF DYNJ902513J:  UDI/DI 10195327662745 (EA) 40195327662746 (CS), Lot number 25EBO161;  REF DYNJ902540O:  UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25ELA305;  REF DYNJ902540O:  UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25DLA166;  REF DYNJ902540O:  UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25CLA999;  REF DYNJ902583N:  UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25FBM125;  REF DYNJ902583N:  UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25DBD973;  REF DYNJ902583N:  UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25BBT778;  REF DYNJ903459J:  UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25FBB837;  REF DYNJ903459J:  UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25DBV160;  REF DYNJ903459J:  UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBK831;  REF DYNJ903459J:  UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBH604;  REF DYNJ903647I:  UDI/DI 10198459016820 (EA) 40198459016821 (CS), Lot number 25EBK700;  REF DYNJ903827F:  UDI/DI 10198459184901 (EA) 40198459184902 (CS), Lot number 25DMJ677;  REF DYNJ903948R:  UDI/DI 10198459104411 (EA) 40198459104412 (CS), Lot number 25CBL682;  REF DYNJ903983P:  UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25FDB185;  REF DYNJ903983P:  UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25DDA847;  REF DYNJ903990Q:  UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25FDB213;  REF DYNJ903990Q:  UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25BDB159;  REF DYNJ904254L:  UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25FBK097;  REF DYNJ904254L:  UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25EBN006;  REF DYNJ904254L:  UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBR174;  REF DYNJ904254L:  UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBB130;  REF DYNJ904254L:  UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25CBC542;  REF DYNJ904343G:  UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25FBJ386;  REF DYNJ904343G:  UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25EBG616;  REF DYNJ904343G:  UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBT550;  REF DYNJ904343G:  UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBO348;  REF DYNJ904343G:  UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBD568;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBT946;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBN312;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBM906;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBO254;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBH661;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBR098;  REF DYNJ904572L:  UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBJ047;  REF DYNJ904597G:  UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25DMB367;  REF DYNJ904597G:  UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25BMF447;  REF DYNJ905289G:  UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25FBM315;  REF DYNJ905289G:  UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25DBB336;  REF DYNJ905289G:  UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25CBC157;  REF DYNJ905730J:  UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DMI347;  REF DYNJ905730J:  UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DME212;  REF DYNJ905746J:  UDI/DI 10198459061455 (EA) 40198459061456 (CS), Lot number 25DMI830;  REF DYNJ905964G:  UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25FBQ752;  REF DYNJ905964G:  UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25CBO349;  REF DYNJ905985O:  UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25EDB456;  REF DYNJ905985O:  UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25CDB971;  REF DYNJ905985O:  UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25BDB112;  REF DYNJ906051C:  UDI/DI 10195327343392 (EA) 40195327343393 (CS), Lot number 25CBJ023;  REF DYNJ906051D:  UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBH988;  REF DYNJ906051D:  UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBE149;  REF DYNJ906112B:  UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25FBN075;  REF DYNJ906112B:  UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBT833;  REF DYNJ906112B:  UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBM894;  REF DYNJ906112B:  UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25DBG798;  REF DYNJ906265D:  UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25DBB516;  REF DYNJ906265D:  UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25CBK354;  REF DYNJ906265F:  UDI/DI 10198459339806 (EA) 40198459339807 (CS), Lot number 25FBI618;  REF DYNJ906322F:  UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25FBH720;  REF DYNJ906322F:  UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25EBF411;  REF DYNJ906322F:  UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBD977;  REF DYNJ906322F:  UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBB800;  REF DYNJ906357C:  UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25FBD902;  REF DYNJ906357C:  UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25EBN653;  REF DYNJ906357C:  UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25DBG849;  REF DYNJ906357C:  UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25CBE442;  REF DYNJ906379D:  UDI/DI 10198459131035 (EA) 40198459131036 (CS), Lot number 25FBK055;  REF DYNJ906444C:  UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25EBL655;  REF DYNJ906444C:  UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25DBA252;  REF DYNJ906444C:  UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25CBJ638;  REF DYNJ906543B:  UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25EBP621;  REF DYNJ906543B:  UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25DBA268;  REF DYNJ906543B:  UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBN673;  REF DYNJ906543B:  UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBE740;  REF DYNJ906731K:  UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25FDA837;  REF DYNJ906731K:  UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25EDB457;  REF DYNJ906731K:  UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25CDA446;  REF DYNJ906731K:  UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25BDB494;  REF DYNJ907072F:  UDI/DI 10195327498481 (EA) 40195327498482 (CS), Lot number 25FLA043;  REF DYNJ907153C:  UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25DBG686;  REF DYNJ907153C:  UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBR320;  REF DYNJ907153C:  UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBB606;  REF DYNJ907153D:  UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBT961;  REF DYNJ907153D:  UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBB608;  REF DYNJ907492F:  UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25CMH362;  REF DYNJ907492F:  UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25BMI302;  REF DYNJ907599C:  UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25FBD904;  REF DYNJ907599C:  UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25DBH124;  REF DYNJ907635D:  UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25EBT433;  REF DYNJ907635D:  UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBL490;  REF DYNJ907635D:  UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBG765;  REF DYNJ907647B:  UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBR238;  REF DYNJ907647B:  UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBA853;  REF DYNJ907647B:  UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25CBQ766;  REF DYNJ907910F:  UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBL209;  REF DYNJ907910F:  UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBE603;  REF DYNJ907919C:  UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25EMH024;  REF DYNJ907919C:  UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMG480;  REF DYNJ907919C:  UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMC385;  REF DYNJ907919C:  UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMB958;  REF DYNJ908447D:  UDI/DI 10195327610753 (EA) 40195327610754 (CS), Lot number 25CBA952;  REF DYNJ908447F:  UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25FBM340;  REF DYNJ908447F:  UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25EBE460;  REF DYNJ908504A:  UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBP390;  REF DYNJ908504A:  UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBK432;  REF DYNJ908783F:  UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25DMC328;  REF DYNJ908783F:  UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25CMG289;  REF DYNJ909120D:  UDI/DI 10198459130540 (EA) 40198459130541 (CS), Lot number 25DBJ949;  REF DYNJ909547:  UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25CBP409;  REF DYNJ909547:  UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25BBH373;  REF DYNJ909548A:  UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25FBN965;  REF DYNJ909548A:  UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25EBH875;  REF DYNJ910137A:  UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25FBE605;  REF DYNJ910137A:  UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25EBD597;  REF DYNJ910137A:  UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25DBD951;  REF DYNJ910991:  UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25EMH063;  REF DYNJ910991:  UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25DMC222;  REF DYNJ910995:  UDI/DI 10198459242038 (EA) 40198459242039 (CS), Lot number 25CMH628;  REF DYNJ9225761X:  UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25FMB646;  REF DYNJ9225761X:  UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25DMA960;  REF DYNJ9225761X:  UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25CMB504;  REF DYNJ9288198X:  UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25EME557;  REF DYNJ9288198X:  UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25DMG373;  REF DYNJ9701096M:  UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25EMH286;  REF DYNJ9701096M:  UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMH432;  REF DYNJ9701096M:  UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMA405;  REF DYNJ9701096M:  UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BMI178;  REF DYNJ9701096M:  UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BME871;  REF PHS722500G:  UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25EMD105;  REF PHS722500G:  UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25CMH699;  REF PHS722500G:  UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25BMI579.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1088-2026%22", "url": "https://recallledger.net/recalls/device-z-1088-2026-medline-medical-procedure-convenience-kits-labeled-as-1-robotic/"}, {"id": "fda-device-z-1087-2026", "source": "FDA", "category": "device", "recall_number": "Z-1087-2026", "title": "Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF;   2) ROBOTIC PROCEDURE, REF CDS982128Q;   3) CUH THORACIC, REF CDS984338M;   4) THORACIC PROCEDURE, REF CDS984640I;   5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O;   6) LAP CHOLE PACK, REF DYNJ57640F;   7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D;   8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D;   9) LAPAROSCOPY PACK, REF DYNJ68187B;   10) LAPAROSCOPY PACK, REF DYNJ82368A;   11) ROBOTIC KIDNEY PACK, REF DYNJ85261;   12) DOWNTOWN ROBOTICS, REF DYNJ86178B;   13) DAVINCI LITHOTOMY PACK, REF DYNJ87610;   14) ROBOTIC WHIPPLE PACK, REF DYNJ88433;   15) PROSTATE DAVINCI, REF DYNJ900127G;   16) GENERAL LAPAROSCOPY, REF DYNJ901847M;   17) LAG TLH, REF DYNJ901890N;   18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S;   19) LAP, REF DYNJ904576B;   20) ROBOTIC, REF DYNJ905147B;   21) ROBOTICS GYN, REF DYNJ905824M;   22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B;   23) CHN OR BASIC ROBOTIC, REF DYNJ905982I;   24) KIT ROBOTIC RFD, REF DYNJ906311F;   25) ROBOTIC PROSTATE, REF DYNJ906381G;   26) DAVINCI, REF DYNJ907392C;   27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C;   28) GYN, REF DYNJ908504B;   29) UROLOGY ROBOTIC, REF DYNJ908588I;   30) THORACIC ROBOTICS, REF DYNJ908777A;   31) GENERAL ROBOT, REF DYNJ908969A;   32) KIT ROBOTIC, REF DYNJ909870B;   33) ROBOTIC THORACOSCOPY, REF DYNJ910924.", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "4536 units", "codes": "REF CDS860237AF:  UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870;  REF CDS860237AF:  UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110;  REF CDS982128Q:  UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253;  REF CDS982128Q:  UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631;  REF CDS984338M:  UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322;  REF CDS984640I:  UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807;  REF DYNJ0525321O:  UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099;  REF DYNJ0525321O:  UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006;  REF DYNJ57640F:  UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347;  REF DYNJ62594D:  UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539;  REF DYNJ62594D:  UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145;  REF DYNJ63392D:  UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967;  REF DYNJ68187B:  UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440;  REF DYNJ82368A:  UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020;  REF DYNJ82368A:  UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917;  REF DYNJ85261:  UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331;  REF DYNJ85261:  UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834;  REF DYNJ86178B:  UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929;  REF DYNJ87610:  UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199;  REF DYNJ88433:  UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621;  REF DYNJ900127G:  UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994;  REF DYNJ900127G:  UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439;  REF DYNJ901847M:  UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364;  REF DYNJ901890N:  UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408;  REF DYNJ901890N:  UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877;  REF DYNJ903948S:  UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236;  REF DYNJ903948S:  UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133;  REF DYNJ904576B:  UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506;  REF DYNJ904576B:  UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329;  REF DYNJ905147B:  UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060;  REF DYNJ905824M:  UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337;  REF DYNJ905824M:  UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465;  REF DYNJ905920B:  UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945;  REF DYNJ905920B:  UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374;  REF DYNJ905982I:  UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934;  REF DYNJ906311F:  UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258;  REF DYNJ906381G:  UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935;  REF DYNJ907392C:  UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137;  REF DYNJ907392C:  UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730;  REF DYNJ907405C:  UDI/DI 10195327541392 (EA) 40195327541393 (CS), Lot Number 25CMF429;  REF DYNJ908504B:  UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25FBG752;  REF DYNJ908504B:  UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25DBS537;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25FDA930;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDB953;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDA576;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25DDA437;  REF DYNJ908588I:  UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25CDB060;  REF DYNJ908777A:  UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577;  REF DYNJ908777A:  UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577Z;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25EBI127;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBP413;  REF DYNJ908969A:  UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBD522;  REF DYNJ909870B:  UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25EBF813;  REF DYNJ909870B:  UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25DBD407;  REF DYNJ910924:  UDI/DI 10198459203442 (EA) 40198459203443 (CS), Lot Number 25EBK656.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1087-2026%22", "url": "https://recallledger.net/recalls/device-z-1087-2026-medline-medical-procedure-convenience-kits-labeled-as-1-wch-bari/"}, {"id": "fda-device-z-1086-2026", "source": "FDA", "category": "device", "recall_number": "Z-1086-2026", "title": "Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) LAPAROSCOPY CDS-LF, REF CDS860235L;   2) GENERAL LAPAROSCOPIC, REF CDS930223M;   3) LAP CHOLE CDS, REF CDS983678K;   4) LAPAROSCOPY PELV CDS, REF CDS983679K;   5) LAP CHOLE CDS-LF, REF CDS983752M;   6) LAP CHOLE CDS-LF, REF CDS984016B;   7) LAP CHOLE KIT, REF CDS984020P;   8) LAP CHOLE-LF, REF CDS984175J;   9) LAP COLON CDS, REF CDS984849N;   10) GENERAL LAPAROSCOPY CDS, REF CDS985328M;   11) LAP CHOLE, REF DYNJQ9044O;   12) GENERAL LAPAROSCOPY V, REF DYNJS2032F;   13) LAP CHOLE PACK, REF DYNJ26209R;   14) LAP CHOLE PACK, REF DYNJ26209S;   15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D;   16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G;   17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G;   18) LAP CHOLE PACK, REF DYNJ51785D;   19) LAPAROSCOPY PACK, REF DYNJ61652A;   20) ENDOSCOPY, REF DYNJ62133A;   21) LAP CHOLE PACK, REF DYNJ66285A;   22) LAPAROSCOPY PACK, REF DYNJ66289B;   23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D;   24) LAPAROSCOPY PACK, REF DYNJ68187A;   25) LAP OB PACK, REF DYNJ68741A;   26) LAP CHOLE PACK-LF, REF DYNJ81408A;   27) LAP CHOLE PACK-LF, REF DYNJ81408B;   28) LAP CHOLE PACK, REF DYNJ85318;   29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677;   30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J;   31) LAP CHOLE, REF DYNJ901126G;   32) BARIATRIC KIT, REF DYNJ901145I;   33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M;   34) LAP GASTRIC SLEEVE, REF DYNJ901504L;   35) GENERAL LAP GASTRIC, REF DYNJ901827X;   36) GENERAL LAPAROSCOPY, REF DYNJ901847N;   37) LOU LAP SIGMOID COLON, REF DYNJ901848L;   38) LAP CHOLE, REF DYNJ901870J;   39) LEX BARIATRIC, REF DYNJ902033L;   40) BARIATRIC, REF DYNJ902515K;   41) LAP CHOLE CDS, REF DYNJ902565K;   42) LAP CHOLE, REF DYNJ902995I;   43) LAP CHOLE, REF DYNJ903163L;   44) LAP APPY, REF DYNJ903164L;   45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C;   46) LAP CHOLE, REF DYNJ904693D;   47) BARIATRIC, REF DYNJ904891N;   48) LAPAROSCOPY, REF DYNJ905071F;   49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F;   50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G;   51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D;   52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A;   53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B;   54) LAP BARIATRIC, REF DYNJ905733K;   55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A;   56) LAP CHOLE, REF DYNJ906277D;   57) LAP CHOLE RFD, REF DYNJ906302D;   58) KIT LAP COLON RFD, REF DYNJ906315D;   59) GASTRIC SLEEVE, REF DYNJ906355D;   60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C;   61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C;   62) GEN BARIATRIC, REF DYNJ907639D;   63) LAP CHOLE, REF DYNJ908415B;   64) LAP CHOLE, REF DYNJ908415C;   65) LAPAROSCOPIC, REF DYNJ908569B;   66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G;   67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A;   68) BARIATRIC CENTRASTATE, REF DYNJ909817A;   69) LAP GENERAL THEDA, REF DYNJ910050;   70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A;   71) ROBOTIC THORACIC, REF DYNJ910386;   72) BARIATRIC, REF DYNJ911017.", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "41432 units", "codes": "REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688;  REF CDS860235L:  UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476;  REF CDS930223M:  UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987;  REF CDS930223M:  UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002;  REF CDS983678K:  UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313;  REF CDS983679K:  UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452;  REF CDS983752M:  UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793;  REF CDS983752M:  UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724;  REF CDS984016B:  UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851;  REF CDS984020P:  UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242;  REF CDS984175J:  UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208;  REF CDS984849N:  UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838;  REF CDS984849N:  UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425;  REF CDS985328M:  UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120;  REF CDS985328M:  UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556;  REF DYNJQ9044O:  UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563;  REF DYNJS2032F:  UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051;  REF DYNJ26209R:  UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526;  REF DYNJ26209S:  UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594;  REF DYNJ37459D:  UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946;  REF DYNJ37459D:  UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606;  REF DYNJ42578G:  UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397;  REF DYNJ45083G:  UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090;  REF DYNJ51785D:  UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326;  REF DYNJ51785D:  UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693;  REF DYNJ61652A:  UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946;  REF DYNJ61652A:  UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811;  REF DYNJ62133A:  UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383;  REF DYNJ66285A:  UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032;  REF DYNJ66289B:  UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558;  REF DYNJ66289B:  UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25DBC195;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25FBM369;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBF833;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBC575;  REF DYNJ67296D:  UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25CBI966;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25FMB779;  REF DYNJ68187A:  UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25DMD529;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25DMH940;  REF DYNJ68741A:  UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25BMH074;  REF DYNJ81408A:  UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit Lot Number 25CMB055;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25FMC540;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMG686;  REF DYNJ81408B:  UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMD691;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25EBL562;  REF DYNJ85318:  UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25CBP974;  REF DYNJ89677:  UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit Lot Number 25CMF548;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25DBP346;  REF DYNJ900969J:  UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25CBH795;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25FBE871;  REF DYNJ901126G:  UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25EBG615;  REF DYNJ901145I:  UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit Lot Number 25EBH921;  REF DYNJ901164M:  UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit Lot Number 25DBR923;  REF DYNJ901504L:  UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit Lot Number 25CBH718;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25FDA155;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25EDA571;  REF DYNJ901827X:  UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25CDA197;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25FBG897;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25EBJ874;  REF DYNJ901847N:  UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25DBM222;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25FBH903;  REF DYNJ901848L:  UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25EBH888;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25EBV494;  REF DYNJ901870J:  UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25DBD971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25EBQ971;  REF DYNJ902033L:  UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25CBR575;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25EBH883;  REF DYNJ902515K:  UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25DBC358;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25EMD967;  REF DYNJ902565K:  UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25DMG347;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25EMH930;  REF DYNJ902995I:  UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25DMB723;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25EME835;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMJ465;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMF401;  REF DYNJ903163L:  UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25BMJ071;  REF DYNJ903164L:  UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit Lot Number 25FMD784;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25FBC756;  REF DYNJ903733C:  UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25EBF091;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25HBJ124;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25FBF713;  REF DYNJ904693D:  UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25DBJ916;  REF DYNJ904891N:  UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit Lot Number 25DBM300;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25EBO479;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBF405;  REF DYNJ905071F:  UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBG629;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25EBN370;  REF DYNJ905390F:  UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25CBR398;  REF DYNJ905390G:  UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit Lot Number 25FBS728;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25EBI282;  REF DYNJ905407D:  UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25CBK566;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25EBK030;  REF DYNJ905413A:  UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25DBF506;  REF DYNJ905413B:  UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit Lot Number 25FBN971;  REF DYNJ905733K:  UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit Lot Number 25DMI831;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25FBL810;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25EBN681;  REF DYNJ905856A:  UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25CBT634;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25FMA366;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25EMB405;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25DMJ507;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMI539;  REF DYNJ906277D:  UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMD374;  REF DYNJ906302D:  UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25EBJ685;  REF DYNJ906302D:  UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25CBN214;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25EBP431;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25DBG969;  REF DYNJ906315D:  UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25CBD708;  REF DYNJ906355D:  UDI/DI 10198459130496 (EA)40198459130497 (CS), Kit Lot Number 25CBR473;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25EBO230;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25DBN709;  REF DYNJ906805C:  UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25CBF802;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25FBJ387;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25EBG494;  REF DYNJ906824C:  UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25DBF817;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25FBL808;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25EBO292;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBU472;  REF DYNJ907639D:  UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBF619;  REF DYNJ908415B:  UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25CLA613;  REF DYNJ908415B:  UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25BLA456;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25FLA028;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25ELA953;  REF DYNJ908415C:  UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25DLA736;  REF DYNJ908569B:  UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25EBK350;  REF DYNJ908569B:  UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25BBI977;  REF DYNJ909119G:  UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25FBP681;  REF DYNJ909119G:  UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25CBM187;  REF DYNJ909628A:  UDI/DI 10198459013751 (EA)40198459013752 (CS), Kit Lot Number 25EBB901;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBP547;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBG101;  REF DYNJ909817A:  UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25EBK620;  REF DYNJ910050:  UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25EMA608;  REF DYNJ910050:  UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25CMI012;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBU030;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBB531;  REF DYNJ910139A:  UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25DBO255;  REF DYNJ910386:  UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25EMF578;  REF DYNJ910386:  UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25DMG348;  REF DYNJ911017:  UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBR251;  REF DYNJ911017:  UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBE132.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1086-2026%22", "url": "https://recallledger.net/recalls/device-z-1086-2026-medline-medical-procedure-convenience-kits-labeled-as-1-laparosco/"}, {"id": "fda-device-z-1085-2026", "source": "FDA", "category": "device", "recall_number": "Z-1085-2026", "title": "Medline medical procedure convenience kits labeled as:    1) THORACIC ROBOTICS recall (Medline Industries, LP)", "product": "Medline medical procedure convenience kits labeled as:    1) THORACIC ROBOTICS, REF DYNJ908777B;   2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359", "reason": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.", "hazard_level": "Class II", "company": "Medline Industries, LP", "company_location": "Northfield, IL, United States", "date": "2025-12-16", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "96 units", "codes": "1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732;  2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1085-2026%22", "url": "https://recallledger.net/recalls/device-z-1085-2026-medline-medical-procedure-convenience-kits-labeled-as-1-thoracic/"}, {"id": "fda-device-z-1084-2026", "source": "FDA", "category": "device", "recall_number": "Z-1084-2026", "title": "Asserachrom HPIA.   Model/Catalog Number: 00615.    The Asserachrom HPIA kit is... recall (Diagnostica Stago, Inc.)", "product": "Asserachrom HPIA.   Model/Catalog Number: 00615.    The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.", "reason": "Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.", "hazard_level": "Class II", "company": "Diagnostica Stago, Inc.", "company_location": "Parsippany, NJ, United States", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.", "states": ["AL", "CA", "FL", "GA", "HI", "IA", "MA", "MI", "NJ", "NV", "NY", "OH", "TN", "WI"], "nationwide": true, "quantity": "438 units", "codes": "Reference Number: 00615.  UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615.  Lot Number: 271288.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1084-2026%22", "url": "https://recallledger.net/recalls/device-z-1084-2026-asserachrom-hpia-model-catalog-number-00615-the-asserachrom-hp/"}, {"id": "fda-device-z-1083-2026", "source": "FDA", "category": "device", "recall_number": "Z-1083-2026", "title": "Brand Name: PALACOS  Product Name: PALACOS MV pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "Brand Name: PALACOS  Product Name: PALACOS MV pro 40; PALACOS MV pro 80  Model/Catalog Number: 5150633; 5150635  Software Version: N/A  Product Description: 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": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2025-12-09", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": false, "quantity": "", "codes": "Lot Code: UDI-DI: 04260102135338; 04260102135369", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1083-2026%22", "url": "https://recallledger.net/recalls/device-z-1083-2026-brand-name-palacos-product-name-palacos-mv-pro-40-palacos-mv-pro-8/"}, {"id": "fda-device-z-1082-2026", "source": "FDA", "category": "device", "recall_number": "Z-1082-2026", "title": "Brand Name: PALACOS  Product Name: PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "Brand Name: PALACOS  Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80  Model/Catalog Number: 5081290; 5081291  Software Version: N/A  Product Description: 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": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2025-12-09", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": false, "quantity": "", "codes": "Lot Code: UDI-DI: 04260102136243; 04260102136274", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1082-2026%22", "url": "https://recallledger.net/recalls/device-z-1082-2026-brand-name-palacos-product-name-palacos-mv-g-pro-40-palacos-mv-g-p/"}, {"id": "fda-device-z-1081-2026", "source": "FDA", "category": "device", "recall_number": "Z-1081-2026", "title": "Brand Name: PALACOS  Product Name: PALACOS R+G pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "Brand Name: PALACOS  Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80  Model/Catalog Number: 5081288; 5081289  Software Version: N/A  Product Description: 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": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2025-12-09", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": false, "quantity": "", "codes": "Lot Code: UDI-DI: 04260102136182; 04260102136212", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2026%22", "url": "https://recallledger.net/recalls/device-z-1081-2026-brand-name-palacos-product-name-palacos-r-g-pro-40-palacos-r-g-pro/"}, {"id": "fda-device-z-1080-2026", "source": "FDA", "category": "device", "recall_number": "Z-1080-2026", "title": "Brand Name: PALACOS  Product Name: PALACOS R pro 40 recall (Heraeus Medical GmbH (Dental Division))", "product": "Brand Name: PALACOS  Product Name: PALACOS R pro 40; PALACOS R pro 80  Model/Catalog Number: 5081286; 5081287  Software Version: N/A  Product Description: 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": "increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.", "hazard_level": "Class II", "company": "Heraeus Medical GmbH (Dental Division)", "company_location": "Wehrheim, Germany", "date": "2025-12-09", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.", "states": [], "nationwide": false, "quantity": "", "codes": "Lot Code: UDI-DI: 04260102136120;  04260102136151", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1080-2026%22", "url": "https://recallledger.net/recalls/device-z-1080-2026-brand-name-palacos-product-name-palacos-r-pro-40-palacos-r-pro-80/"}, {"id": "fda-device-z-1079-2026", "source": "FDA", "category": "device", "recall_number": "Z-1079-2026", "title": "Philips Azurion Systems R3.0. Includes the following label descriptions and... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:    1. Azurion 3 M12. Model Number: 722229.     2. Azurion 3 M15. Model Number: 722230.     3. Azurion 5 M12. Model Number: 722231.     4. Azurion 5 M20. Model Number: 722232.     5. Azurion 7 B12. Model Number: 722235.     6. Azurion 7 B20. Model Number: 722236.     7. Azurion 7 M12. Model Number: 722233.     8. Azurion 7 M20. Model Number: 722234.", "reason": "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-08", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.", "states": [], "nationwide": true, "quantity": "990 units", "codes": "Software Version: R3.0.   1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29.   2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22.  3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75, (01)00884838116740(21)33, (01)00884838116740(21)47, (01)00884838116740(21)60, (01)00884838116740(21)53, (01)00884838116740(21)45, (01)00884838116740(21)61, (01)00884838116740(21)34, (01)00884838116740(21)54, (01)00884838116740(21)35, (01)00884838116740(21)49, (01)00884838116740(21)32, (01)00884838116740(21)28, (01)00884838116740(21)27, (01)00884838116740(21)26, (01)00884838116740(21)51, (01)00884838116740(21)11, (01)00884838116740(21)20, (01)00884838116740(21)41, (01)00884838116740(21)52, (01)00884838116740(21)3.   4. Model Number: 722232. UDI Numbers: (01)00884838116757(21)61, (01)00884838116757(21)60, (01)00884838116757(21)5, (01)00884838116757(21)49, (01)00884838116757(21)2, (01)00884838116757(21)91, (01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)23, (01)00884838116757(21)43, (01)00884838116757(21)36, (01)00884838116757(21)96, (01)00884838116757(21)95, (01)00884838116757(21)10, (01)00884838116757(21)76, (01)00884838116757(21)42, (01)00884838116757(21)6, (01)00884838116757(21)77, (01)00884838116757(21)3, (01)00884838116757(21)1, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)44, (01)00884838116757(21)30, (01)00884838116757(21)29, (01)00884838116757(21)28, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)8, (01)00884838116757(21)81, (01)00884838116757(21)20, (01)00884838116757(21)16, (01)00884838116757(21)11, (01)00884838116757(21)112, (01)00884838116757(21)63, (01)00884838116757(21)68, (01)00884838116757(21)32, (01)00884838116757(21)35, (01)00884838116757(21)122, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)13, (01)00884838116757(21)50, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)4, (01)00884838116757(21)105, (01)00884838116757(21)75, (01)00884838116757(21)121, (01)00884838116757(21)120, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)73, (01)00884838116757(21)70, (01)00884838116757(21)69, (01)00884838116757(21)37.  5. Model Number: 722235. UDI Numbers: (01)00884838116788(21)88, (01)00884838116788(21)43, (01)00884838116788(21)12, (01)00884838116788(21)102, (01)00884838116788(21)127, (01)00884838116788(21)57, (01)00884838116788(21)55, (01)00884838116788(21)11, (01)00884838116788(21)76, (01)00884838116788(21)71, (01)00884838116788(21)59, (01)00884838116788(21)77, (01)00884838116788(21)89, (01)00884838116788(21)56, (01)00884838116788(21)99, (01)00884838116788(21)30, (01)00884838116788(21)84, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)93, (01)00884838116788(21)31, (01)00884838116788(21)47, (01)00884838116788(21)3, (01)00884838116788(21)13, (01)00884838116788(21)10, (01)00884838116788(21)74, (01)00884838116788(21)98, (01)00884838116788(21)40, (01)00884838116788(21)81, (01)00884838116788(21)66, (01)00884838116788(21)63, (01)00884838116788(21)67, (01)00884838116788(21)64, (01)00884838116788(21)42, (01)00884838116788(21)65, (01)00884838116788(21)58, (01)00884838116788(21)53, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)44, (01)00884838116788(21)35, (01)00884838116788(21)45, (01)00884838116788(21)39, (01)00884838116788(21)25, (01)00884838116788(21)34, (01)00884838116788(21)17, (01)00884838116788(21)24, (01)00884838116788(21)19, (01)00884838116788(21)33, (01)00884838116788(21)18, (01)00884838116788(21)9, (01)00884838116788(21)28, (01)00884838116788(21)8, (01)00884838116788(21)23, (01)00884838116788(21)21, (01)00884838116788(21)6, (01)00884838116788(21)7, (01)00884838116788(21)5, (01)00884838116788(21)108, (01)00884838116788(21)109, (01)00884838116788(21)107, (01)00884838116788(21)106, (01)00884838116788(21)4, (01)00884838116788(21)41, (01)00884838116788(21)72, (01)00884838116788(21)70, (01)00884838116788(21)54, (01)00884838116788(21)20, (01)00884838116788(21)14, (01)00884838116788(21)126, (01)00884838116788(21)105, (01)00884838116788(21)94.  6. Model Number: 722236. UDI Numbers: (01)00884838116801(21)43, (01)00884838116801(21)42, (01)00884838116801(21)121, (01)00884838116801(21)50, (01)00884838116801(21)183, (01)00884838116801(21)32, (01)00884838116801(21)38, (01)00884838116801(21)197, (01)00884838116801(21)335, (01)00884838116801(21)325, (01)00884838116801(21)116, (01)00884838116801(21)191, (01)00884838116801(21)235, (01)00884838116801(21)22, (01)00884838116801(21)204, (01)00884838116801(21)249, (01)00884838116801(21)159, (01)00884838116801(21)40, (01)00884838116801(21)233, (01)00884838116801(21)194, (01)00884838116801(21)205, (01)00884838116801(21)276, (01)00884838116801(21)378, (01)00884838116801(21)20, (01)00884838116801(21)81, (01)00884838116801(21)51, (01)00884838116801(21)288, (01)00884838116801(21)25, (01)00884838116801(21)54, (01)00884838116801(21)186, (01)00884838116801(21)21, (01)00884838116801(21)68, (01)00884838116801(21)99, (01)00884838116801(21)208, (01)00884838116801(21)31, (01)00884838116801(21)230, (01)00884838116801(21)203, (01)00884838116801(21)180, (01)00884838116801(21)37, (01)00884838116801(21)342, (01)00884838116801(21)24, (01)00884838116801(21)221, (01)00884838116801(21)17, (01)00884838116801(21)252, (01)00884838116801(21)150, (01)00884838116801(21)60, (01)00884838116801(21)200, (01)00884838116801(21)226, (01)00884838116801(21)118, (01)00884838116801(21)127, (01)00884838116801(21)26, (01)00884838116801(21)36, (01)00884838116801(21)133, (01)00884838116801(21)345, (01)00884838116801(21)134, (01)00884838116801(21)131, (01)00884838116801(21)39, (01)00884838116801(21)231, (01)00884838116801(21)158, (01)00884838116801(21)48, (01)00884838116801(21)227, (01)00884838116801(21)148, (01)00884838116801(21)147, (01)00884838116801(21)272, (01)00884838116801(21)273, (01)00884838116801(21)100, (01)00884838116801(21)224, (01)00884838116801(21)164, (01)00884838116801(21)163, (01)00884838116801(21)170, (01)00884838116801(21)44, (01)00884838116801(21)46, (01)00884838116801(21)113, (01)00884838116801(21)216, (01)00884838116801(21)278, (01)00884838116801(21)102, (01)00884838116801(21)8, (01)00884838116801(21)169, (01)00884838116801(21)338, (01)00884838116801(21)117, (01)00884838116801(21)29, (01)00884838116801(21)34, (01)00884838116801(21)10, (01)00884838116801(21)126, (01)00884838116801(21)237, (01)00884838116801(21)125, (01)00884838116801(21)154, (01)00884838116801(21)157, (01)00884838116801(21)30, (01)00884838116801(21)67, (01)00884838116801(21)292, (01)00884838116801(21)289, (01)00884838116801(21)277, (01)00884838116801(21)244, (01)00884838116801(21)181, (01)00884838116801(21)264, (01)00884838116801(21)232, (01)00884838116801(21)207, (01)00884838116801(21)192, (01)00884838116801(21)132, (01)00884838116801(21)128, (01)00884838116801(21)160, (01)00884838116801(21)94, (01)00884838116801(21)86, (01)00884838116801(21)41, (01)00884838116801(21)27, (01)00884838116801(21)259, (01)00884838116801(21)251, (01)00884838116801(21)261, (01)00884838116801(21)57, (01)00884838116801(21)240, (01)00884838116801(21)107, (01)00884838116801(21)172, (01)00884838116801(21)142, (01)00884838116801(21)109, (01)00884838116801(21)55, (01)00884838116801(21)171, (01)00884838116801(21)155, (01)00884838116801(21)175, (01)00884838116801(21)111, (01)00884838116801(21)88, (01)00884838116801(21)104, (01)00884838116801(21)152, (01)00884838116801(21)124, (01)00884838116801(21)103, (01)00884838116801(21)90, (01)00884838116801(21)70, (01)00884838116801(21)153, (01)00884838116801(21)106, (01)00884838116801(21)151, (01)00884838116801(21)144, (01)00884838116801(21)141, (01)00884838116801(21)76, (01)00884838116801(21)112, (01)00884838116801(21)105, (01)00884838116801(21)85, (01)00884838116801(21)62, (01)00884838116801(21)52, (01)00884838116801(21)75, (01)00884838116801(21)92, (01)00884838116801(21)89, (01)00884838116801(21)108, (01)00884838116801(21)59, (01)00884838116801(21)73, (01)00884838116801(21)84, (01)00884838116801(21)69, (01)00884838116801(21)83, (01)00884838116801(21)80, (01)00884838116801(21)64, (01)00884838116801(21)74, (01)00884838116801(21)53, (01)00884838116801(21)49, (01)00884838116801(21)329, (01)00884838116801(21)130, (01)00884838116801(21)326, (01)00884838116801(21)168, (01)00884838116801(21)145, (01)00884838116801(21)146, (01)00884838116801(21)98, (01)00884838116801(21)96, (01)00884838116801(21)93, (01)00884838116801(21)258, (01)00884838116801(21)56, (01)00884838116801(21)91, (01)00884838116801(21)271, (01)00884838116801(21)201, (01)00884838116801(21)123, (01)00884838116801(21)162, (01)00884838116801(21)122, (01)00884838116801(21)114, (01)00884838116801(21)63, (01)00884838116801(21)374, (01)00884838116801(21)357, (01)00884838116801(21)348, (01)00884838116801(21)347, (01)00884838116801(21)352, (01)00884838116801(21)322, (01)00884838116801(21)330, (01)00884838116801(21)321, (01)00884838116801(21)188, (01)00884838116801(21)283, (01)00884838116801(21)285, (01)00884838116801(21)284, (01)00884838116801(21)269, (01)00884838116801(21)193, (01)00884838116801(21)173, (01)00884838116801(21)311, (01)00884838116801(21)156, (01)00884838116801(21)219, (01)00884838116801(21)167, (01)00884838116801(21)33, (01)00884838116801(21)268, (01)00884838116801(21)23, (01)00884838116801(21)361, (01)00884838116801(21)242, (01)00884838116801(21)223, (01)00884838116801(21)234, (01)00884838116801(21)182, (01)00884838116801(21)189, (01)00884838116801(21)165, (01)00884838116801(21)82, (01)00884838116801(21)66, (01)00884838116801(21)13.  7. Model Number: 722233. UDI Numbers: (01)00884838116764(21)118, (01)00884838116764(21)96, (01)00884838116764(21)259, (01)00884838116764(21)169, (01)00884838116764(21)108, (01)00884838116764(21)212, (01)00884838116764(21)267, (01)00884838116764(21)214, (01)00884838116764(21)147, (01)00884838116764(21)153, (01)00884838116764(21)111, (01)00884838116764(21)122, (01)00884838116764(21)124, (01)00884838116764(21)127, (01)00884838116764(21)59, (01)00884838116764(21)172, (01)00884838116764(21)64, (01)00884838116764(21)170, (01)00884838116764(21)41, (01)00884838116764(21)103, (01)00884838116764(21)144, (01)00884838116764(21)219, (01)00884838116764(21)218, (01)00884838116764(21)192, (01)00884838116764(21)30, (01)00884838116764(21)189, (01)00884838116764(21)186, (01)00884838116764(21)17, (01)00884838116764(21)9, (01)00884838116764(21)245, (01)00884838116764(21)57, (01)00884838116764(21)32, (01)00884838116764(21)203, (01)00884838116764(21)205, (01)00884838116764(21)204, (01)00884838116764(21)184, (01)00884838116764(21)162, (01)00884838116764(21)18, (01)00884838116764(21)83, (01)00884838116764(21)84, (01)00884838116764(21)88, (01)00884838116764(21)76, (01)00884838116764(21)137, (01)00884838116764(21)85, (01)00884838116764(21)86, (01)00884838116764(21)87, (01)00884838116764(21)46, (01)00884838116764(21)47, (01)00884838116764(21)26, (01)00884838116764(21)234, (01)00884838116764(21)200, (01)00884838116764(21)250, (01)00884838116764(21)201, (01)00884838116764(21)123, (01)00884838116764(21)235, (01)00884838116764(21)68, (01)00884838116764(21)14, (01)00884838116764(21)82, (01)00884838116764(21)27, (01)00884838116764(21)38, (01)00884838116764(21)37, (01)00884838116764(21)8, (01)00884838116764(21)145, (01)00884838116764(21)112, (01)00884838116764(21)95, (01)00884838116764(21)173, (01)00884838116764(21)202, (01)00884838116764(21)101, (01)00884838116764(21)165, (01)00884838116764(21)166, (01)00884838116764(21)97, (01)00884838116764(21)81, (01)00884838116764(21)61, (01)00884838116764(21)31, (01)00884838116764(21)29, (01)00884838116764(21)109, (01)00884838116764(21)279, (01)00884838116764(21)260, (01)00884838116764(21)221, (01)00884838116764(21)178, (01)00884838116764(21)181, (01)00884838116764(21)159, (01)00884838116764(21)117, (01)00884838116764(21)141, (01)00884838116764(21)120, (01)00884838116764(21)273, (01)00884838116764(21)163, (01)00884838116764(21)272, (01)00884838116764(21)174, (01)00884838116764(21)249, (01)00884838116764(21)78, (01)00884838116764(21)133, (01)00884838116764(21)102, (01)00884838116764(21)106, (01)00884838116764(21)104, (01)00884838116764(21)80, (01)00884838116764(21)77, (01)00884838116764(21)206, (01)00884838116764(21)67, (01)00884838116764(21)39, (01)00884838116764(21)15, (01)00884838116764(21)13, (01)00884838116764(21)179, (01)00884838116764(21)180, (01)00884838116764(21)136, (01)00884838116764(21)129, (01)00884838116764(21)222, (01)00884838116764(21)149, (01)00884838116764(21)148, (01)00884838116764(21)146, (01)00884838116764(21)5, (01)00884838116764(21)51, (01)00884838116764(21)19, (01)00884838116764(21)7, (01)00884838116764(21)6, (01)00884838116764(21)231, (01)00884838116764(21)107, (01)00884838116764(21)91, (01)00884838116764(21)89, (01)00884838116764(21)90, (01)00884838116764(21)71, (01)00884838116764(21)48, (01)00884838116764(21)74, (01)00884838116764(21)62, (01)00884838116764(21)55, (01)00884838116764(21)50, (01)00884838116764(21)43, (01)00884838116764(21)40, (01)00884838116764(21)11, (01)00884838116764(21)35, (01)00884838116764(21)60, (01)00884838116764(21)28, (01)00884838116764(21)20, (01)00884838116764(21)12, (01)00884838116764(21)138, (01)00884838116764(21)139, (01)00884838116764(21)58, (01)00884838116764(21)257, (01)00884838116764(21)160, (01)00884838116764(21)24, (01)00884838116764(21)268, (01)00884838116764(21)284, (01)00884838116764(21)291, (01)00884838116764(21)238, (01)00884838116764(21)225, (01)00884838116764(21)217, (01)00884838116764(21)211, (01)00884838116764(21)16, (01)00884838116764(21)110, (01)00884838116764(21)183, (01)00884838116764(21)143, (01)00884838116764(21)134, (01)00884838116764(21)44, (01)00884838116764(21)197.   8. Model Number: 722234. UDI Numbers: (01)00884838116771(21)626, (01)00884838116771(21)320, (01)00884838116771(21)256, (01)00884838116771(21)321, (01)00884838116771(21)437, (01)00884838116771(21)101, (01)00884838116771(21)616, (01)00884838116771(21)418, (01)00884838116771(21)426, (01)00884838116771(21)87, (01)00884838116771(21)420, (01)00884838116771(21)827, (01)00884838116771(21)716, (01)00884838116771(21)607, (01)00884838116771(21)183, (01)00884838116771(21)345, (01)00884838116771(21)520, (01)00884838116771(21)662, (01)00884838116771(21)327, (01)00884838116771(21)524, (01)00884838116771(21)191, (01)00884838116771(21)201, (01)00884838116771(21)449, (01)00884838116771(21)435, (01)00884838116771(21)657, (01)00884838116771(21)171, (01)00884838116771(21)124, (01)00884838116771(21)123, (01)00884838116771(21)79, (01)00884838116771(21)409, (01)00884838116771(21)70, (01)00884838116771(21)55, (01)00884838116771(21)68, (01)00884838116771(21)780, (01)00884838116771(21)794, (01)00884838116771(21)500, 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"recall_number": "Z-1078-2026", "title": "MOSAIQ Oncology Information System with Particle Therapy License recall (Elekta, Inc.)", "product": "MOSAIQ Oncology Information System with Particle Therapy License  (License Kit 45700000000IQRO)", "reason": "Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice", "hazard_level": "Class II", "company": "Elekta, Inc.", "company_location": "Atlanta, GA, United States", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the state of TX.", "states": ["TX"], "nationwide": true, "quantity": "1", "codes": "MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base.  Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1  UDI-DI: 07340201500026, 07340201500071", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2026%22", "url": "https://recallledger.net/recalls/device-z-1078-2026-mosaiq-oncology-information-system-with-particle-therapy-license-lic/"}, {"id": "fda-device-z-1077-2026", "source": "FDA", "category": "device", "recall_number": "Z-1077-2026", "title": "Allura Xper FD20/20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20/20; Model Number: 722038;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. 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If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "4 units", "codes": "Model Number: 722029; System Product Name: Allura Xper FD20/10; UDI-DI: 00884838054219; Serial Numbers: 30, 81, 80, 47;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2026%22", "url": "https://recallledger.net/recalls/device-z-1076-2026-allura-xper-fd20-10-model-number-722029/"}, {"id": "fda-device-z-1075-2026", "source": "FDA", "category": "device", "recall_number": "Z-1075-2026", "title": "Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20; Model Number: 722028;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. 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If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "4 units", "codes": "Model Number: 722023; System Product Name: Allura Xper FD20 OR Table; UDI-DI: 00884838059085; Serial Numbers: 103, 10, 85, 125;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2026%22", "url": "https://recallledger.net/recalls/device-z-1072-2026-allura-xper-fd20-or-table-model-number-722023/"}, {"id": "fda-device-z-1071-2026", "source": "FDA", "category": "device", "recall_number": "Z-1071-2026", "title": "Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20 Biplane; Model Number: 722013;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "23 units", "codes": "Model Number: 722013; System Product Name: Allura Xper FD20 Biplane; UDI-DI: 00884838059061; Serial Numbers: 601, 230, 370, 27, 320, 193, 60, 373, 560, 400, 549, 506, 381, 382, 132, 169, 233, 236, 243, 526, 447, 163, 403;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1071-2026%22", "url": "https://recallledger.net/recalls/device-z-1071-2026-allura-xper-fd20-biplane-model-number-722013/"}, {"id": "fda-device-z-1070-2026", "source": "FDA", "category": "device", "recall_number": "Z-1070-2026", "title": "Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20; Model Number: 722012;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. 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This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "79 units", "codes": "Model Number: 722012; System Product Name: Allura Xper FD20; UDI-DI: 00884838059054; Serial Numbers: 2942, 1515, 1189, 1594, 535, 1964, 2156, 2742, 2092, 1673, 1803, 1655, 2020, 1973, 2037, 1853, 2098, 1248, 1082, 1576, 1057, 1129, 646, 930, 1421, 462, 203, 627, 2005, 1428, 353, 288, 191, 1994, 1802, 156, 853, 1283, 1956, 2361, 1980, 872, 931, 1295, 2513, 1090, 1374, 468, 1822, 812, 1379, 1817, 1580, 1050, 309, 144, 1841, 1845, 1468, 558, 1968, 1959, 2168, 1168, 1562, 967, 2114, 47, 167, 2091, 2053, 604, 603, 217, 2918, 373, 850, 1820, 1821, 1619;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2026%22", "url": "https://recallledger.net/recalls/device-z-1070-2026-allura-xper-fd20-model-number-722012/"}, {"id": "fda-device-z-1069-2026", "source": "FDA", "category": "device", "recall_number": "Z-1069-2026", "title": "Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD10/10; Model Number: 722011;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "21 units", "codes": "Model Number: 722011; System Product Name: Allura Xper FD10/10; UDI-DI: 00884838059047; Serial Numbers: 268, 205, 213, 89, 293, 294, 116, 272, 113, 152, 112, 139, 141, 111, 81, 66, 46, 153, 115, 114, 274;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1069-2026%22", "url": "https://recallledger.net/recalls/device-z-1069-2026-allura-xper-fd10-10-model-number-722011/"}, {"id": "fda-device-z-1068-2026", "source": "FDA", "category": "device", "recall_number": "Z-1068-2026", "title": "Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD10; Model Number: 722010;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "56 units", "codes": "Model Number: 722010; System Product Name: Allura Xper FD10; UDI-DI: 00884838059030; Serial Numbers: 764, 1396, 728, 980, 782, 125, 1096, 661, 225, 1055, 1185, 368, 743, 1006, 570, 901, 552, 973, 795, 888, 1140, 781, 1060, 354, 186, 516, 517, 64, 386, 387, 530, 996, 964, 1265, 525, 307, 1189, 98, 774, 935, 721, 254, 1008, 1213, 1273, 66, 156, 304, 1422, 388, 235, 236, 1066, 1090, 549, 689;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1068-2026%22", "url": "https://recallledger.net/recalls/device-z-1068-2026-allura-xper-fd10-model-number-722010/"}, {"id": "fda-device-z-1067-2026", "source": "FDA", "category": "device", "recall_number": "Z-1067-2026", "title": "Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20 Biplane; Model Number: 722008;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "18 units", "codes": "Model Number: 722008; System Product Name: Allura Xper FD20 Biplane; UDI-DI: N/A; Serial Numbers: 296, 245, 141, 260, 13, 410, 196, 476, 488, 290, 339, 474, 383, 530, 722008530, 223, 468, 63;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1067-2026%22", "url": "https://recallledger.net/recalls/device-z-1067-2026-allura-xper-fd20-biplane-model-number-722008/"}, {"id": "fda-device-z-1066-2026", "source": "FDA", "category": "device", "recall_number": "Z-1066-2026", "title": "Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD20; Model Number: 722006;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "143 units", "codes": "Model Number: 722006; System Product Name: Allura Xper FD20; UDI-DI: N/A; Serial Numbers: 1370, 1376, 225, 249, 1273, 1496, 707, 1466, 1141, 1201, 359, 105, 285, 1433, 822, 1747, 318, 797, 124, 1518, 384, 1045, 328, 302, 1536, 514, 910, 2123, 1360, 1381, 149, 379, 387, 1733, 197, 314, 888, 189, 310, 209, 863, 325, 378, 2110, 166, 118, 1978, 304, 1696, 2524, 248, 1928, 294, 804, 1227, 56, 245, 1560, 1795, 902, 1295, 1123, 1424, 1958, 40, 1222, 1947, 2289, 1687, 2304, 666, 2086, 958, 1801, 2546, 1317, 1478, 589, 2154, 1557, 1580, 519, 273, 157, 1504, 836, 1365, 393, 2428, 1902, 2433, 1521, 115, 2023, 1003, 1509, 1494, 2171, 2391, 867, 1513, 29, 951, 1814, 284, 482, 455, 1763, 1899, 1968, 837, 856, 1537, 93, 1561, 1746, 1232, 430, CV.797, 1974, 507, 1949, 1275, 1427, 1967, 374, 116, CV.507, 7567201, 2225, 267, 931, 344, 745, 233, 506, 2230, 1864, 457, 280, 1556, 640, 2;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1066-2026%22", "url": "https://recallledger.net/recalls/device-z-1066-2026-allura-xper-fd20-model-number-722006/"}, {"id": "fda-device-z-1065-2026", "source": "FDA", "category": "device", "recall_number": "Z-1065-2026", "title": "Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD10/10; Model Number: 722005;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "14 units", "codes": "Model Number: 722005; System Product Name: Allura Xper FD10/10; UDI-DI: N/A; Serial Numbers: 93, 269, 530, 306, 307, 247, 53, 401, 141, 531, 184, 75, 276, 36;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1065-2026%22", "url": "https://recallledger.net/recalls/device-z-1065-2026-allura-xper-fd10-10-model-number-722005/"}, {"id": "fda-device-z-1064-2026", "source": "FDA", "category": "device", "recall_number": "Z-1064-2026", "title": "Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD10; Model Number: 722003;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "93 units", "codes": "Model Number: 722003; System Product Name: Allura Xper FD10; UDI-DI: N/A; Serial Numbers: 1232, 967, 746, 1276, 232, 385, 1663, 1189, 81, 700, 167, 1072, 994, 150, 135, 1268, 168, 855, 213, 60, 471, 153, 319, 1159, 162, 180, 142, 1205, 719, 926, 426, 1413, 798, 65, 1165, 1658, 1193, 1778, 2933, 1585, 1380, 1706, 1613, 1685, 1297, 1388, 1522, 1238, 1416, 1448, 536, 1090, 1662, 1083, 1433, 1399, 62, 943, 249, 1227, 163, 1121, 1119, 889, 861, 1649, PP0200000118, 804, 1527, 468, 1593, 1198, 1022, 708, 1054, 865, 744, 1760, 936, 782, 953, 1035, 1058, 179, 1254, 1112, 389, 1560, 1660, 1013, 25, 215, 27;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1064-2026%22", "url": "https://recallledger.net/recalls/device-z-1064-2026-allura-xper-fd10-model-number-722003/"}, {"id": "fda-device-z-1063-2026", "source": "FDA", "category": "device", "recall_number": "Z-1063-2026", "title": "Allura Xper FD10F recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Allura Xper FD10F; Model Number: 722002;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "12 units", "codes": "Model Number: 722002; System Product Name: Allura Xper FD10F; UDI-DI: N/A; Serial Numbers: 61, 56, 27, 81, 25, 85, 20, 21, 84, 50, 31, 40;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1063-2026%22", "url": "https://recallledger.net/recalls/device-z-1063-2026-allura-xper-fd10f-model-number-722002/"}, {"id": "fda-device-z-1062-2026", "source": "FDA", "category": "device", "recall_number": "Z-1062-2026", "title": "Product Name: Allura Xper FD10C recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)", "product": "Product Name: Allura Xper FD10C; Model number: 722001;", "reason": "Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.", "hazard_level": "Class II", "company": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "company_location": "Best, Netherlands", "date": "2025-12-15", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.", "states": [], "nationwide": true, "quantity": "38 units", "codes": "Model Number: 722001; System Product Name: Allura Xper FD10C; UDI-DI: N/A; Serial Numbers: 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, 299, 30, 235, 221, 348, 283, 276, 253, 1100, 78, 229, 232, 159, 177, 219, 217, 205, 3, 89, 101, 295, 305;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1062-2026%22", "url": "https://recallledger.net/recalls/device-z-1062-2026-product-name-allura-xper-fd10c-model-number-722001/"}, {"id": "fda-device-z-1047-2026", "source": "FDA", "category": "device", "recall_number": "Z-1047-2026", "title": "MAXXUS recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)", "product": "MAXXUS,     System, Tomography, Computed, Emission", "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and  listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.    There have been no reports of detector falls or injuries as a result of this potential issue.    The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.", "hazard_level": "Class II", "company": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "company_location": "Tirat Carmel, Israel", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece", "states": [], "nationwide": false, "quantity": "38 units", "codes": "UDI/DI Not applicable:  All serial numbers in distribution", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2026%22", "url": "https://recallledger.net/recalls/device-z-1047-2026-maxxus-system-tomography-computed-emission/"}, {"id": "fda-device-z-1046-2026", "source": "FDA", "category": "device", "recall_number": "Z-1046-2026", "title": "SMV BodyTrack recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)", "product": "SMV BodyTrack,     System, Tomography, Computed, Emission", "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and  listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.    There have been no reports of detector falls or injuries as a result of this potential issue.    The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.", "hazard_level": "Class II", "company": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "company_location": "Tirat Carmel, Israel", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece", "states": [], "nationwide": false, "quantity": "12 units", "codes": "UDI/DI Not applicable:  All serial numbers in distribution", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1046-2026%22", "url": "https://recallledger.net/recalls/device-z-1046-2026-smv-bodytrack-system-tomography-computed-emission/"}, {"id": "fda-device-z-1045-2026", "source": "FDA", "category": "device", "recall_number": "Z-1045-2026", "title": "SMV DSI recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)", "product": "SMV DSI,     System, Tomography, Computed, Emission", "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and  listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.    There have been no reports of detector falls or injuries as a result of this potential issue.    The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.", "hazard_level": "Class II", "company": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "company_location": "Tirat Carmel, Israel", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece", "states": [], "nationwide": false, "quantity": "3 units", "codes": "UDI/DI Not applicable:  All serial numbers in distribution", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2026%22", "url": "https://recallledger.net/recalls/device-z-1045-2026-smv-dsi-system-tomography-computed-emission/"}, {"id": "fda-device-z-1044-2026", "source": "FDA", "category": "device", "recall_number": "Z-1044-2026", "title": "SMV DSX New Line recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)", "product": "SMV DSX New Line,     System, Tomography, Computed, Emission", "reason": "GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and  listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.    There have been no reports of detector falls or injuries as a result of this potential issue.    The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.", "hazard_level": "Class II", "company": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "company_location": "Tirat Carmel, Israel", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece", "states": [], "nationwide": false, "quantity": "7 units", "codes": "UDI/DI Not applicable:  All serial numbers in distribution", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2026%22", "url": "https://recallledger.net/recalls/device-z-1044-2026-smv-dsx-new-line-system-tomography-computed-emission/"}, {"id": "fda-device-z-1043-2026", "source": "FDA", "category": "device", "recall_number": "Z-1043-2026", "title": "A71200 Vanta\" Clinician Programmer Application recall (Medtronic Neuromodulation)", "product": "A71200 Vanta\" Clinician Programmer Application (CP App) version  2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).", "reason": "Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.", "hazard_level": "Class II", "company": "Medtronic Neuromodulation", "company_location": "Minneapolis, MN, United States", "date": "2025-12-03", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "7123", "codes": "version 2.0.2465 and 2.0.2683  UDI-DI (GTIN) 00763000520083  Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1043-2026%22", "url": "https://recallledger.net/recalls/device-z-1043-2026-a71200-vanta-clinician-programmer-application-cp-app-version-2-0-2/"}, {"id": "fda-device-z-1042-2026", "source": "FDA", "category": "device", "recall_number": "Z-1042-2026", "title": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter recall (Boston Scientific Corporation)", "product": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,   1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;   2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;   Catheter, Angioplasty, Peripheral, Transluminal", "reason": "Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.", "hazard_level": "Class II", "company": "Boston Scientific Corporation", "company_location": "Maple Grove, MN, United States", "date": "2025-12-03", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of MA, WV, OH, CA, MN, NY, VA, IL TX, FL, IL.", "states": ["CA", "FL", "IL", "MA", "MN", "NY", "OH", "TX", "VA", "WV"], "nationwide": true, "quantity": "21 units", "codes": "1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28;  2) GTIN 08714729796756, Batch Number  37416646, exp. 9-Sept-28", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1042-2026%22", "url": "https://recallledger.net/recalls/device-z-1042-2026-boston-scientific-coyote-over-the-wire-pta-balloon-dilation-catheter/"}, {"id": "fda-device-z-1041-2026", "source": "FDA", "category": "device", "recall_number": "Z-1041-2026", "title": "Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography recall (Mobius Imaging, LLC)", "product": "Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.", "reason": "AIRO pendant replacement kits and upgrade do not possess the \"Safe Hand Position Warning\" label.", "hazard_level": "Class II", "company": "Mobius Imaging, LLC", "company_location": "Shirley, MA, United States", "date": "2025-12-04", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.", "states": ["AK", "AL", "AZ", "CA", "CO", "CT", "DC", "FL", "IL", "KY", "MA", "MD", "MI", "MN", "MO", "NC", "NY", "OH", "PA", "RI", "SC", "TN", "TX", "UT", "VA", "WI"], "nationwide": true, "quantity": "26 units", "codes": "Part No. MI-70-0128; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206183, 2232206193, 2232206203, 2232206213, 2232206223, 2232206233, 2235522143, 2235522153, 2235522163, 2236339153, 2236339163, 2236339173, 2236339183, 2303429483, 2303429503, 2313925663, 2313925673, 2316030773, 2316030783, 2316703503, 2316703523, 2317415473, 2320006923, 2320006933, 2323513413, 70-0128-13904392.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2026%22", "url": "https://recallledger.net/recalls/device-z-1041-2026-detachable-10in-pendant-upgrade-component-for-the-airo-computed-tomogr/"}, {"id": "fda-device-z-1040-2026", "source": "FDA", "category": "device", "recall_number": "Z-1040-2026", "title": "Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography recall (Mobius Imaging, LLC)", "product": "Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.", "reason": "AIRO pendant replacement kits and upgrade do not possess the \"Safe Hand Position Warning\" label.", "hazard_level": "Class II", "company": "Mobius Imaging, LLC", "company_location": "Shirley, MA, United States", "date": "2025-12-04", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.", "states": ["AK", "AL", "AZ", "CA", "CO", "CT", "DC", "FL", "IL", "KY", "MA", "MD", "MI", "MN", "MO", "NC", "NY", "OH", "PA", "RI", "SC", "TN", "TX", "UT", "VA", "WI"], "nationwide": true, "quantity": "101 units", "codes": "Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373, 2303430383, 2303430393, 2304034583, 2304034593, 2304034603, 2304034613, 2304034623, 2305514123, 2305514133, 2305514143, 2305514153, 2311019263, 2315101273, 2315101283, 2315101293, 2315101303, 2316030903, 2316030913, 2316703793, 2316703803, 2316703813, 2316703823, 2317415513, 2317415523, 2317415533, 2317415543, 2317415553, 2317905083, 2317905093, 2317905103, 2317905113, 2317905123, 2323513673, 2323513683, 2323513693, 2331419663, 2331419673, 2332117403, 2332117413, 2332117423, 2332117433, 2332117443, 2333404593, 2333404603, 2335506763, 2335506773, 2401909563, 2401909573, 2401909583, 2401909593, 2401909603, 2401909613, 2402911603, 2402911613, 2402911623, 2402911633, 2404302243, 2404302253, 2404302263, 2404302273, 2409620273, 2409620283, 2409620293, 2409620303, 2422207853, 2422207863, 2422207873, 2422207883, 2422207893, 2422207903, 2422207913, 2426303233, 2426303243, 2426303253, 2426303263, 2426303273, 2426303283, 2431210783, 2431210793, 2431210803, 2431210813, 2431210823, 2434504553, 2434504563, 2434504573, 2502103553, 2502103583, 2502103593, 2503121733, 2503121743, 2503121753, 2503616113, 2503616123, 2503616133, 2503616213.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1040-2026%22", "url": "https://recallledger.net/recalls/device-z-1040-2026-detachable-10in-pend-fru-1-pend-component-for-the-airo-computed-tomogr/"}, {"id": "fda-device-z-1024-2026", "source": "FDA", "category": "device", "recall_number": "Z-1024-2026", "title": "MAVERICK¿ Measurement Module Spectrometer PN 820-01367 recall (REPLIGEN CORPORATION)", "product": "MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496", "reason": "Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.", "hazard_level": "Class II", "company": "REPLIGEN CORPORATION", "company_location": "Marlborough, MA, United States", "date": "2025-12-10", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "U.S.", "states": [], "nationwide": false, "quantity": "33", "codes": "PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1024-2026%22", "url": "https://recallledger.net/recalls/device-z-1024-2026-maverick-measurement-module-spectrometer-pn-820-01367-originally-par/"}, {"id": "fda-device-z-1018-2026", "source": "FDA", "category": "device", "recall_number": "Z-1018-2026", "title": "VANTAGE TITAN 3T  Model MRT-3010/MEXL-3010 recall (Canon Medical System, USA, INC.)", "product": "VANTAGE TITAN 3T  Model MRT-3010/MEXL-3010", "reason": "There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise.  This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2025-12-19", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.", "states": ["CA", "CO", "FL", "IA", "IL", "IN", "KS", "MD", "MO", "MT", "NV", "NY", "OH", "OR", "PA", "PR", "TX", "VA", "WI"], "nationwide": true, "quantity": "22 systems", "codes": "Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041  MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708  MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894  MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175  MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314  MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354  MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719  MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553  MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579  MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918  MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122  MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387  MRT-3010/A5 MEXL-3010/A5 A5B11Y2005 351452  MRT-3010/A5 MEXL-3010/A5 A5C1262013 356865  MRT-3010/A5 MEXL-3010/A5 A5C1292015 378015  MRT-3010/A5 MEXL-3010/A5 A5C1412028 383946  MRT-3010/A5 MEXL-3010/A5 A5E1522033 389630  MRT-3010/A5 MEXL-3010/A5 A5D1362021 390397", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2026%22", "url": "https://recallledger.net/recalls/device-z-1018-2026-vantage-titan-3t-model-mrt-3010-mexl-3010/"}, {"id": "fda-device-z-1017-2026", "source": "FDA", "category": "device", "recall_number": "Z-1017-2026", "title": "VANTAGE GALAN 3T  Model MRT-3020/MEXL-3020 recall (Canon Medical System, USA, INC.)", "product": "VANTAGE GALAN 3T  Model MRT-3020/MEXL-3020", "reason": "There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise.  This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.", "hazard_level": "Class II", "company": "Canon Medical System, USA, INC.", "company_location": "Tustin, CA, United States", "date": "2025-12-19", "report_date": "2026-01-21", "status": "Ongoing", "distribution": "U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.", "states": ["CA", "CO", "FL", "IA", "IL", "IN", "KS", "MD", "MO", "MT", "NV", "NY", "OH", "OR", "PA", "PR", "TX", "VA", "WI"], "nationwide": true, "quantity": "34 systems", "codes": "Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012 MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015 MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013 MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017 MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016 MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001 MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003  MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1017-2026%22", "url": "https://recallledger.net/recalls/device-z-1017-2026-vantage-galan-3t-model-mrt-3020-mexl-3020/"}, {"id": "fda-food-h-0410-2026", "source": "FDA", "category": "food", "recall_number": "H-0410-2026", "title": "Bengal King Jhal Chanachur food treats 12.34oz recall (South Asian Food Inc.)", "product": "Bengal King Jhal Chanachur food treats 12.34oz (350gm)", "reason": "Contains undeclared peanuts", "hazard_level": "Class I", "company": "South Asian Food Inc.", "company_location": "Maspeth, NY, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Terminated", "distribution": "CA, NY, NJ, DE, VA, FL, GA, MA, MD, WI", "states": ["CA", "DE", "FL", "GA", "MA", "MD", "NJ", "NY", "VA", "WI"], "nationwide": false, "quantity": "95 boxes (each contains 24 jars)", "codes": "lot B No.HCNCU1205/24  expiration date of June-2026 UPC:  8941153046243.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0410-2026%22", "url": "https://recallledger.net/recalls/food-h-0410-2026-bengal-king-jhal-chanachur-food-treats-12-34oz-350gm/"}, {"id": "fda-food-h-0380-2026", "source": "FDA", "category": "food", "recall_number": "H-0380-2026", "title": "MARKET 32 by Price Chopper brand recall (DIRECT SOURCE SEAFOOD LLC)", "product": "MARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green printing. UPC is 0 41735 01358 3.    Product of Indonesia. PROUDLY DISTRIBUTED BY PRICE CHOPPER, INC. SCHENECTADY, NY 12306.", "reason": "Shrimp may be contaminated with Cesium-137 (Cs-137).", "hazard_level": "Class II", "company": "DIRECT SOURCE SEAFOOD LLC", "company_location": "Bellevue, WA, United States", "date": "2025-12-18", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Market 32 brand frozen raw shrimp was sold in CT, MA, NH, NY, PA, and VT.  waterfront BISTRO frozen raw shrimp was sold in CO, IA, ID, IL, IN, MT, ND, NV, OR, UT, and WY.", "states": ["CO", "CT", "IA", "ID", "IL", "IN", "MA", "MT", "ND", "NH", "NV", "NY", "OR", "PA", "UT", "VT", "WY"], "nationwide": false, "quantity": "MARKET 32 = 3290 cases", "codes": "DSBMS2557 25112 Best By: 04/22/27 DS503 139 T  DSBMS2557 25113 Best By: 04/23/27 DS503 139 T  DSBMS2557 25114 Best By: 04/24/27 DS503 080 T  DSBMS2558 25116 Best By: 04/26/27 DS504 080 T  DSBMS2558 25117 Best By: 04/27/27 DS504 139 T  Code is interpreted as follows: DS = Direct Source Seafood BMS = Bahari Makmur Sejati 2557 = code assigned to imported container 2558 = code assigned to imported container 25113, 25114, 25116, 25117 = Julian date of production DS503 or DS504 = Plant-specific code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0380-2026%22", "url": "https://recallledger.net/recalls/food-h-0380-2026-market-32-by-price-chopper-brand-frozen-raw-shrimp-easy-peel-shell-on/"}, {"id": "fda-food-h-0379-2026", "source": "FDA", "category": "food", "recall_number": "H-0379-2026", "title": "waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count... recall (DIRECT SOURCE SEAFOOD LLC)", "product": "waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is 0 21130 13224 9.   Product of Indonesia. DISTRIBUTED BY LUCERNE FOODS, INC. P.O. BOX 99 PLEASANTON, CA 94566.", "reason": "Shrimp may be contaminated with Cesium-137 (Cs-137).", "hazard_level": "Class II", "company": "DIRECT SOURCE SEAFOOD LLC", "company_location": "Bellevue, WA, United States", "date": "2025-12-18", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Market 32 brand frozen raw shrimp was sold in CT, MA, NH, NY, PA, and VT.  waterfront BISTRO frozen raw shrimp was sold in CO, IA, ID, IL, IN, MT, ND, NV, OR, UT, and WY.", "states": ["CO", "CT", "IA", "ID", "IL", "IN", "MA", "MT", "ND", "NH", "NV", "NY", "OR", "PA", "UT", "VT", "WY"], "nationwide": false, "quantity": "waterfront Bistro shrimp = 1800 cases", "codes": "DSBMS2559 25115 S5060-5100 Best If Used By: APR 25 2027  DSBMS2559 25116 S5060-5100 Best If Used By: APR 26 2027  Code is interpreted as follows: DS = Direct Source Seafood BMS = Bahari Makmur Sejati 2559 = code assigned to imported container 25115 = Julian date of production 25116 = Julian date of production S5060-5100 = Plant-specific code", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0379-2026%22", "url": "https://recallledger.net/recalls/food-h-0379-2026-waterfront-bistro-brand-frozen-raw-shrimp-ez-peel-shell-tail-on-colo/"}, {"id": "fda-food-h-0378-2026", "source": "FDA", "category": "food", "recall_number": "H-0378-2026", "title": "Baraka Gourmet Pastry Kunafe 6.7oz. recall (ZIYAD BROTHERS IMPORTING)", "product": "Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case", "reason": "May contain partially hydrogenated oils", "hazard_level": "Class II", "company": "ZIYAD BROTHERS IMPORTING", "company_location": "Bolingbrook, IL, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "575 cases", "codes": "LOT 164024 EXP 15.JUN.2026 LOT 340024 EXP  07.DEC.2025 LOT 049025 EXP 18.FEB.2027 LOT 155025 EXP 04.JUN.2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0378-2026%22", "url": "https://recallledger.net/recalls/food-h-0378-2026-baraka-gourmet-pastry-kunafe-6-7oz-upc-822514291060-18-retail-units/"}, {"id": "fda-food-h-0377-2026", "source": "FDA", "category": "food", "recall_number": "H-0377-2026", "title": "Baraka French Style Puff Pastry 1lb and 1.5lbs sizes recall (ZIYAD BROTHERS IMPORTING)", "product": "Baraka French Style Puff Pastry 1lb and 1.5lbs sizes, UPCs 8 22514 28540 3 and 8 22514 28550 2, both sizes 12 retail units per wholesale case", "reason": "May contain partially hydrogenated oils", "hazard_level": "Class II", "company": "ZIYAD BROTHERS IMPORTING", "company_location": "Bolingbrook, IL, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "2865 cases", "codes": "LOT 165024 EXP 13.JUN.2026 LOT 352024 EXP 17.DEC.2025 LOT 048025 EXP 17.FEB.2027 LOT 146025 EXP 26.MAY.2027 LOT 164024 EXP 12.JUN.2026 LOT 097025 EXP 07.APR.2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0377-2026%22", "url": "https://recallledger.net/recalls/food-h-0377-2026-baraka-french-style-puff-pastry-1lb-and-1-5lbs-sizes-upcs-8-22514-285/"}, {"id": "fda-food-h-0376-2026", "source": "FDA", "category": "food", "recall_number": "H-0376-2026", "title": "Sysco Imperial Potato Tater Barrel recall (McCain Foods USA Inc)", "product": "Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per case. UPC 1 07 34730 62740 0.  Distributed by Sysco Corporation, Houston, TX. Product of U.S.A.", "reason": "Clear hard plastic fragments.", "hazard_level": "Class II", "company": "McCain Foods USA Inc", "company_location": "Burley, ID, United States", "date": "2025-12-03", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in AK, AZ, CA, CO, FL, HI, IA, ID, IL, KS, KY, LA, MI, MN, MO, MS, MT, NE, NM, ND, NV, OR, TX, UT, WA, WI.", "states": ["AK", "AZ", "CA", "CO", "FL", "HI", "IA", "ID", "IL", "KS", "KY", "LA", "MI", "MN", "MO", "MS", "MT", "ND", "NE", "NM", "NV", "OR", "TX", "UT", "WA", "WI"], "nationwide": false, "quantity": "17,597 cases", "codes": "Batch Codes: 1005482717, 1005483735, 1005484702, 1005485462, 1005485660  Production Dates: 11505 R, 11605 R, 11705 R, 11705 R, 11805 R  11805 R represents date 10/18/2025 and R is Plant Identifier for McCain Burley.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0376-2026%22", "url": "https://recallledger.net/recalls/food-h-0376-2026-sysco-imperial-potato-tater-barrel-item-number-1000006067-frozen-pot/"}, {"id": "fda-food-h-0375-2026", "source": "FDA", "category": "food", "recall_number": "H-0375-2026", "title": "Ore-Ida Tater Tots shaped potatoes recall (McCain Foods USA Inc)", "product": "Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.", "reason": "Clear hard plastic fragments.", "hazard_level": "Class II", "company": "McCain Foods USA Inc", "company_location": "Burley, ID, United States", "date": "2025-12-03", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in AK, AZ, CA, CO, FL, HI, IA, ID, IL, KS, KY, LA, MI, MN, MO, MS, MT, NE, NM, ND, NV, OR, TX, UT, WA, WI.", "states": ["AK", "AZ", "CA", "CO", "FL", "HI", "IA", "ID", "IL", "KS", "KY", "LA", "MI", "MN", "MO", "MS", "MT", "ND", "NE", "NM", "NV", "OR", "TX", "UT", "WA", "WI"], "nationwide": false, "quantity": "21,256 cases", "codes": "Batch Codes: 1005479808, 1005477924, 1005478883, 1005480444, 1005480875, 1005481627, 1005481770  Production Dates: E 20271009, E 20271010, E 20271011, E 20271012, E 20271013, E 20271014", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0375-2026%22", "url": "https://recallledger.net/recalls/food-h-0375-2026-ore-ida-tater-tots-shaped-potatoes-item-number-oif00215a-frozen-pota/"}, {"id": "fda-food-h-0366-2026", "source": "FDA", "category": "food", "recall_number": "H-0366-2026", "title": "Sapori Amaretti Almonds 175 g Cookies recall (D. Coluccio & Sons Inc.)", "product": "Sapori Amaretti Almonds 175 g Cookies", "reason": "Contains elevated levels of hydrocyanic acid", "hazard_level": "Class II", "company": "D. Coluccio & Sons Inc.", "company_location": "Brooklyn, NY, United States", "date": "2025-12-14", "report_date": "2026-01-14", "status": "Terminated", "distribution": "NY, NJ, GA, CA", "states": ["CA", "GA", "NJ", "NY"], "nationwide": false, "quantity": "800 units", "codes": "Lot L355122 1 - Best Before Date: 02.05.2026 LotL355246 1 - Best Before Date: 03.09.2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0366-2026%22", "url": "https://recallledger.net/recalls/food-h-0366-2026-sapori-amaretti-almonds-175-g-cookies/"}, {"id": "fda-food-h-0363-2026", "source": "FDA", "category": "food", "recall_number": "H-0363-2026", "title": "Tita Crackers Rovira recall (Rovira Biscuit Corporation)", "product": "Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121  Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343  Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case.", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "29,246 units", "codes": "Lot numbers: 6/8oz  13125 21025 22425 31725 42125 42926 51925 61625 62325 70125 71425 72225 81125 90225 92225 100725 101424 110625 112224  Lot numbers: 6/24oz  13125 21025 22425 31725 42125 42926 51925 61625 62325 71425 72225 81125 90225 92225 100725 101424 110625 112224 120825  Lot number: 420/24 oz cans 110625", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0363-2026%22", "url": "https://recallledger.net/recalls/food-h-0363-2026-tita-crackers-rovira-3-1-2-oz-15g-foil-fresh-packets-net-wt-8-oz/"}, {"id": "fda-food-h-0362-2026", "source": "FDA", "category": "food", "recall_number": "H-0362-2026", "title": "Vainilla Crackers recall (Rovira Biscuit Corporation)", "product": "Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "16,478 units", "codes": "Lot numbers:  11625 12725 21325 30325 40725 42926 50625 52625 60925 62425 70125 71525 80425 91624 91825 92925 103025 111124 111325 112524 112525 121624 011625", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0362-2026%22", "url": "https://recallledger.net/recalls/food-h-0362-2026-vainilla-crackers-great-value-galletas-vainilla-8-foil-packets-17-g/"}, {"id": "fda-food-h-0361-2026", "source": "FDA", "category": "food", "recall_number": "H-0361-2026", "title": "Vanilla Treats Crackers recall (Rovira Biscuit Corporation)", "product": "Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case.  Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "71,492 units", "codes": "Lot numbers: 6/31 oz cans 11625 12725 21325 30325 40725 42926 50625 52625 60925 62425 70125 71525 80425 91624 91825 92925 103025 111124 111325 112524 112525 121624  Lot number: 6/9.6oz  11625 12725 21325 30325 40725 42926 50625 52625 60925 62425 70125 71525 80425 91624 91825 92925 103025 111124 111325 112524 112525 121624", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0361-2026%22", "url": "https://recallledger.net/recalls/food-h-0361-2026-vanilla-treats-crackers-rovira-net-wt-31-oz-878-83-g-cans-6-31oz/"}, {"id": "fda-food-h-0360-2026", "source": "FDA", "category": "food", "recall_number": "H-0360-2026", "title": "Vanilla Econo recall (Rovira Biscuit Corporation)", "product": "Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "22,114 units", "codes": "Lot numbers:  11625 12725 21325 40725 50625 52625 60925 71525 80425 91624 91825 92925 103025 111124 111325 112524 121624 062425", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0360-2026%22", "url": "https://recallledger.net/recalls/food-h-0360-2026-vanilla-econo-galletas-de-vainilla-8-paquets-per-net-wt-9-6-oz-box/"}, {"id": "fda-food-h-0359-2026", "source": "FDA", "category": "food", "recall_number": "H-0359-2026", "title": "Tempting Crackers Tray recall (Rovira Biscuit Corporation)", "product": "Tempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127  Tempting Crackers, Rovira, 12 packets (Net Wt. 1.0 oz (30 g) bag) per box, 12/ 1.0 oz packets box, 6/ 12-1oz box per case. UPC 072981003127", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "9,838 units", "codes": "Lot numbers:  10725 21025 31025 50426 50525 63025 70125 80924 91925 111824", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0359-2026%22", "url": "https://recallledger.net/recalls/food-h-0359-2026-tempting-crackers-tray-rovira-3-foil-wrap-trays-per-net-wt-8oz-box/"}, {"id": "fda-food-h-0358-2026", "source": "FDA", "category": "food", "recall_number": "H-0358-2026", "title": "Snack Crackers 100to en boca recall (Rovira Biscuit Corporation)", "product": "Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064  100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035  100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073", "reason": "Undeclared colors FD&C Yellow #6, and FD&C Red 40", "hazard_level": "Class II", "company": "Rovira Biscuit Corporation", "company_location": "Ponce, PR, United States", "date": "2025-12-17", "report_date": "2026-01-14", "status": "Terminated", "distribution": "GA, TX, MA, IL, MD, USVI and Puerto Rico. Foreign Panama and BVI", "states": ["GA", "IL", "MA", "MD", "PR", "TX"], "nationwide": false, "quantity": "6,671 units", "codes": "Lot numbers: 12/ 1.5 oz 11625 12725 21325 40725 50125 52625 60925 62425 71525 80425 91624 91825 92925 103025 111124 111325 112524 121624 011625  Lot numbers: 18/ 7 oz 10825 10925 11025 21125 21225 31425 31725 31825 42225 42325 42425 42525 42926 51225 51325 53025 60225 61725 61825 62025 70125 72425 72925 82125 82225 82825 91824 102125 102225 102325 102425 102725 102825 120924", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0358-2026%22", "url": "https://recallledger.net/recalls/food-h-0358-2026-snack-crackers-100to-en-boca-ciento-en-boca-rovira-net-wt-1-5-oz/"}, {"id": "fda-food-h-0357-2026", "source": "FDA", "category": "food", "recall_number": "H-0357-2026", "title": "Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 recall (Sam Dry Fruits and Nuts Enterprises, Inc)", "product": "Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027", "reason": "Potential contamination with Salmonella.", "hazard_level": "Class I", "company": "Sam Dry Fruits and Nuts Enterprises, Inc", "company_location": "Modesto, CA, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S. Distribution: None Foreign Distribution: Canada", "states": [], "nationwide": false, "quantity": "32,610 lbs (1,087 cases)", "codes": "LOT #: PK00459", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0357-2026%22", "url": "https://recallledger.net/recalls/food-h-0357-2026-sam-dry-fruits-nuts-pistachio-meats-whole-lot-pk00459-net-weight/"}, {"id": "fda-food-h-0356-2026", "source": "FDA", "category": "food", "recall_number": "H-0356-2026", "title": "Eggs Potatoes Cheese Tacos recall (Fresh & Ready Foods LLC)", "product": "Eggs Potatoes Cheese Tacos, Evergreen Refreshments brand, Ready to Eat, Refrigerated. Net wt. 6.3 oz. UPC 100040103898, EG03698v01. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.", "reason": "Foreign material.", "hazard_level": "Class II", "company": "Fresh & Ready Foods LLC", "company_location": "Renton, WA, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in OR and WA.", "states": ["OR", "WA"], "nationwide": false, "quantity": "200 units", "codes": "LPK1WA336 Best By: 12 DEC", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0356-2026%22", "url": "https://recallledger.net/recalls/food-h-0356-2026-eggs-potatoes-cheese-tacos-evergreen-refreshments-brand-ready-to-eat/"}, {"id": "fda-food-h-0355-2026", "source": "FDA", "category": "food", "recall_number": "H-0355-2026", "title": "Spicy Egg Potatoes Cheese Tacos recall (Fresh & Ready Foods LLC)", "product": "Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.", "reason": "Foreign material.", "hazard_level": "Class II", "company": "Fresh & Ready Foods LLC", "company_location": "Renton, WA, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in OR and WA.", "states": ["OR", "WA"], "nationwide": false, "quantity": "62 units", "codes": "LPK1WA336 Best By: 12 DEC", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0355-2026%22", "url": "https://recallledger.net/recalls/food-h-0355-2026-spicy-egg-potatoes-cheese-tacos-fresh-to-you-brand-ready-to-eat-ref/"}, {"id": "fda-food-h-0354-2026", "source": "FDA", "category": "food", "recall_number": "H-0354-2026", "title": "Spicy Breakfast Burrito recall (Fresh & Ready Foods LLC)", "product": "Spicy Breakfast Burrito, Sprig & Sprout brand, Ready to Eat. Refrigerated. Net wt. 9.1oz. UPC 100001000297, SS00297v02. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.", "reason": "Foreign material.", "hazard_level": "Class II", "company": "Fresh & Ready Foods LLC", "company_location": "Renton, WA, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in OR and WA.", "states": ["OR", "WA"], "nationwide": false, "quantity": "93 units", "codes": "LPK1WA336 Best By: 12 DEC", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0354-2026%22", "url": "https://recallledger.net/recalls/food-h-0354-2026-spicy-breakfast-burrito-sprig-sprout-brand-ready-to-eat-refrigera/"}, {"id": "fda-food-h-0353-2026", "source": "FDA", "category": "food", "recall_number": "H-0353-2026", "title": "Spicy Veggie Breakfast Burrito recall (Fresh & Ready Foods LLC)", "product": "Spicy Veggie Breakfast Burrito, Fresh to You, Ready to Eat, Refrigerated. Net wt. 9.1oz. UPC 100000010310, LPK110310V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057", "reason": "Foreign material.", "hazard_level": "Class II", "company": "Fresh & Ready Foods LLC", "company_location": "Renton, WA, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Terminated", "distribution": "Distributed in OR and WA.", "states": ["OR", "WA"], "nationwide": false, "quantity": "278 units", "codes": "LPK1WA336 Best By: 12 DEC", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0353-2026%22", "url": "https://recallledger.net/recalls/food-h-0353-2026-spicy-veggie-breakfast-burrito-fresh-to-you-ready-to-eat-refrigerat/"}, {"id": "fda-food-h-0352-2026", "source": "FDA", "category": "food", "recall_number": "H-0352-2026", "title": "Lunds & Byerlys Monster Cookies recall (Lund Food Holdings Inc)", "product": "Lunds & Byerlys Monster Cookies, Net Wt 10.0 oz (284g).. UPC 0 18169-66862 7.  Lunds & Byerlys, Edina, MN  55424", "reason": "Undeclared allergens (Peanut, Egg, Soy)", "hazard_level": "Class I", "company": "Lund Food Holdings Inc", "company_location": "Eden Prairie, MN, United States", "date": "2025-12-03", "report_date": "2026-01-14", "status": "Terminated", "distribution": "MN", "states": ["MN"], "nationwide": false, "quantity": "108 cases (12 units per case)", "codes": "Lot 501301", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0352-2026%22", "url": "https://recallledger.net/recalls/food-h-0352-2026-lunds-byerlys-monster-cookies-net-wt-10-0-oz-284g-upc-0-18169-6/"}, {"id": "fda-drug-d-0292-2026", "source": "FDA", "category": "drug", "recall_number": "D-0292-2026", "title": "Rosuvastatin Tablets recall (AvKARE)", "product": "Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478.  NDC:  50268-709-15", "reason": "Out of specification for dissolution.", "hazard_level": "Class II", "company": "AvKARE", "company_location": "Pulaski, TN, United States", "date": "2025-12-31", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "7,991 5x10 cartons", "codes": "Lot #49124, Exp Date 12/31/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0292-2026%22", "url": "https://recallledger.net/recalls/drug-d-0292-2026-rosuvastatin-tablets-usp-10-mg-rx-only-50-tablets-5-x-10-unit-do/"}, {"id": "fda-drug-d-0289-2026", "source": "FDA", "category": "drug", "recall_number": "D-0289-2026", "title": "ClearLife Allergy Nasal Spray recall (Medinatura New Mexico, inc.)", "product": "ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887", "reason": "Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.", "hazard_level": "Class I", "company": "Medinatura New Mexico, inc.", "company_location": "Albuquerque, NM, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Nationwide in the US", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2026%22", "url": "https://recallledger.net/recalls/drug-d-0289-2026-clearlife-allergy-nasal-spray-extra-strength-0-68-fl-oz-20-ml-bo/"}, {"id": "fda-drug-d-0288-2026", "source": "FDA", "category": "drug", "recall_number": "D-0288-2026", "title": "ReBoost Nasal Spray recall (Medinatura New Mexico, inc.)", "product": "ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863", "reason": "Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.", "hazard_level": "Class I", "company": "Medinatura New Mexico, inc.", "company_location": "Albuquerque, NM, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Nationwide in the US", "states": [], "nationwide": true, "quantity": "", "codes": "All lots within expiry.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2026%22", "url": "https://recallledger.net/recalls/drug-d-0288-2026-reboost-nasal-spray-0-68-fl-oz-20-ml-bottles-distributed-by-med/"}, {"id": "fda-drug-d-0255-2026", "source": "FDA", "category": "drug", "recall_number": "D-0255-2026", "title": "Oxycodone and Acetaminophen CII Tablets USP recall (SpecGx, LLC)", "product": "Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01.  Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493", "reason": "Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.", "hazard_level": "Class II", "company": "SpecGx, LLC", "company_location": "Webster Groves, MO, United States", "date": "2025-12-16", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "74,544 bottles", "codes": "Lot: 0522J23493, expires: 03/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0255-2026%22", "url": "https://recallledger.net/recalls/drug-d-0255-2026-oxycodone-and-acetaminophen-cii-tablets-usp-7-5-mg-325-mg-100-tablet/"}, {"id": "fda-drug-d-0254-2026", "source": "FDA", "category": "drug", "recall_number": "D-0254-2026", "title": "Oxycodone and Acetaminophen CII Tablets USP recall (SpecGx, LLC)", "product": "Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.", "reason": "Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.", "hazard_level": "Class II", "company": "SpecGx, LLC", "company_location": "Webster Groves, MO, United States", "date": "2025-12-16", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Nationwide", "states": [], "nationwide": true, "quantity": "287,988 Bottles.", "codes": "Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0254-2026%22", "url": "https://recallledger.net/recalls/drug-d-0254-2026-oxycodone-and-acetaminophen-cii-tablets-usp-10mg-325-mg-100-tablets/"}, {"id": "fda-drug-d-0253-2026", "source": "FDA", "category": "drug", "recall_number": "D-0253-2026", "title": "ORL Kids Natural Toothpaste recall (Signature Formulations, LLC)", "product": "ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA", "reason": "cGMP Deviations", "hazard_level": "Class II", "company": "Signature Formulations, LLC", "company_location": "Phoenix, AZ, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "AZ only", "states": ["AZ"], "nationwide": false, "quantity": "1,458 containers", "codes": "Lot #: 250520P4, Exp. Date 05/27", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0253-2026%22", "url": "https://recallledger.net/recalls/drug-d-0253-2026-orl-kids-natural-toothpaste-bubblegum-flavor-4-oz-120ml-orl-labs/"}, {"id": "fda-drug-d-0252-2026", "source": "FDA", "category": "drug", "recall_number": "D-0252-2026", "title": "ORL Kids Mouthwash recall (Signature Formulations, LLC)", "product": "ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA", "reason": "cGMP Deviations", "hazard_level": "Class II", "company": "Signature Formulations, LLC", "company_location": "Phoenix, AZ, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "AZ only", "states": ["AZ"], "nationwide": false, "quantity": "570 bottles", "codes": "Lot #: 250505P9, Exp. Date 05/27", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0252-2026%22", "url": "https://recallledger.net/recalls/drug-d-0252-2026-orl-kids-mouthwash-bubblegum-flavor-16-9-oz-500ml-per-bottle-orl/"}, {"id": "fda-drug-d-0251-2026", "source": "FDA", "category": "drug", "recall_number": "D-0251-2026", "title": "Tri-Moxi+¿ recall (Imprimis NJOF, LLC)", "product": "Tri-Moxi+¿  (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.", "reason": "Presence of particulate matter - Glass like particles.", "hazard_level": "Class II", "company": "Imprimis NJOF, LLC", "company_location": "Ledgewood, NJ, United States", "date": "2025-12-18", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S Nationwide", "states": [], "nationwide": true, "quantity": "314 boxes of 6,280 pre-filled syringes", "codes": "Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0251-2026%22", "url": "https://recallledger.net/recalls/drug-d-0251-2026-tri-moxi-triamcinolone-9mg-0-6ml-moxifloxacin-0-6-mg-0-6-ml-sin/"}, {"id": "fda-drug-d-0250-2026", "source": "FDA", "category": "drug", "recall_number": "D-0250-2026", "title": "Dexamethasone  Moxifloxacin  Ketorolac recall (Imprimis NJOF, LLC)", "product": "Dexamethasone  Moxifloxacin  Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.", "reason": "Presence of particulate matter - Glass like particles.", "hazard_level": "Class II", "company": "Imprimis NJOF, LLC", "company_location": "Ledgewood, NJ, United States", "date": "2025-12-18", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S Nationwide", "states": [], "nationwide": true, "quantity": "596 boxes of 11,920 pre-filled syringes", "codes": "Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0250-2026%22", "url": "https://recallledger.net/recalls/drug-d-0250-2026-dexamethasone-moxifloxacin-ketorolac-1-mg-ml-0-5-mg-ml-0-4-mg-ml/"}, {"id": "fda-drug-d-0249-2026", "source": "FDA", "category": "drug", "recall_number": "D-0249-2026", "title": "Dexamethasone   Moxifloxacin recall (Imprimis NJOF, LLC)", "product": "Dexamethasone   Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1", "reason": "Presence of particulate matter - Glass like particles.", "hazard_level": "Class II", "company": "Imprimis NJOF, LLC", "company_location": "Ledgewood, NJ, United States", "date": "2025-12-18", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S Nationwide", "states": [], "nationwide": true, "quantity": "778 boxes of 15,540 pre-filled syringes", "codes": "Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0249-2026%22", "url": "https://recallledger.net/recalls/drug-d-0249-2026-dexamethasone-moxifloxacin-1-mg-ml-and-5-mg-ml-1-ml-intraocular-in/"}, {"id": "fda-drug-d-0248-2026", "source": "FDA", "category": "drug", "recall_number": "D-0248-2026", "title": "Fesoterodine Fumarate recall (Alembic Pharmaceuticals Limited)", "product": "Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30", "reason": "Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.", "hazard_level": "Class III", "company": "Alembic Pharmaceuticals Limited", "company_location": "Panchmahal, India", "date": "2025-12-16", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "US Nationwide and PR.", "states": ["PR"], "nationwide": true, "quantity": "", "codes": "Lot# 2405003360, Exp Date: Jan 31, 2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0248-2026%22", "url": "https://recallledger.net/recalls/drug-d-0248-2026-fesoterodine-fumarate-extended-release-tablets-8-mg-30-tablets-rx/"}, {"id": "fda-device-z-1037-2026", "source": "FDA", "category": "device", "recall_number": "Z-1037-2026", "title": "Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.     The Codman CereLink... recall (Integra LifeSciences Corp. (NeuroSciences))", "product": "Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.     The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit.     Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.", "reason": "Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.", "hazard_level": "Class II", "company": "Integra LifeSciences Corp. (NeuroSciences)", "company_location": "Princeton, NJ, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of 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, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).", "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", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "SD", "TN", "TX", "UT", "VA", "WA"], "nationwide": true, "quantity": "5,116 units", "codes": "Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 7482183, 7482184, 7482185, 7482186, 7468772, 7482154, 7482155, 7482156, 7482157, 7468801, 7468804, 7468805, 7468806, 7482136, 7468802, 7468803, 7482132, 7482134, 7482135, 7482137, 7482159, 7482158, 7482160, 7482161, 7495593, 7495594, 7495596, 7495597, 7495598, 7495599, 7482212, 7495600, 7495601, 7495602, 7495603, 7495604, 7495605, 7495606, 7495607, 7495608, 7495635, 7495636, 7495637, 7495638, 7495639, 7495640, 7495641, 7495642, 7495643, 7495666, 7495644, 7495664, 7482213, 7495667, 7503597, 7503598, 7503599, 7503659, 7510140, 7510141, 7510142, 7503600, 7503601, 7517716, 7517708, 7503627, 7503628, 7503630, 7503631, 7503632, 7503633, 7503629, 7503664, 7503657, 7503662, 7503663, 7503602, 7503624, 7510156, 7517703, 7517704, 7517706, 7517707, 7517709, 7517710, 7517711, 7517712, 7517714, 7517715, 7408817, 7411797, 7411798, 7411799, 7411800, 7414643, 7414644, 7414645, 7414646, 7414647, 7414648, 7414649, 7417938, 7417940, 7417942, 7417944, 7417946, 7417948, 7417950, 7417952, 7417955, 7417957, 7417959, 7503625.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1037-2026%22", "url": "https://recallledger.net/recalls/device-z-1037-2026-codman-cerelink-icp-sensor-basic-kit-catalog-number-826850-the/"}, {"id": "fda-device-z-1036-2026", "source": "FDA", "category": "device", "recall_number": "Z-1036-2026", "title": "Codman Microsensor Basic Kit. Catalog Number: 626631US.     Use of the CODMAN... recall (Integra LifeSciences Corp. (NeuroSciences))", "product": "Codman Microsensor Basic Kit. Catalog Number: 626631US.     Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.", "reason": "Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.", "hazard_level": "Class II", "company": "Integra LifeSciences Corp. (NeuroSciences)", "company_location": "Princeton, NJ, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide - US Nationwide distribution in the states of 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, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX UT, VA WA and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia (Plurinational State of), Brazil, Canada, Chile, China, Colombia, Cyprus, Czechia, France, Georgia, Germany, Greece, Hong Kong, Iceland, India, Ireland, Israel, Italy, Japan, Kenya, Korea (the Republic of), Lithuania, Nepal, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).", "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", "NJ", "NV", "NY", "OH", "OK", "OR", "PA", "SC", "SD", "TN", "TX", "UT", "VA", "WA"], "nationwide": true, "quantity": "1,301 units", "codes": "Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990, 7305991, 7307683, 7325489, 7336088, 7336089, 7336090, 7305992, 7346223, 7391752, 7391751, 7406650, 7406651, 7406652, 7408825, 7408826, 7408827, 7456174, 7456175, 7456176, 7456179, 7478039, 7478040, 7480073, 7480072, 7482162, 7503704, 7507495, 7503608, 7510153, 7510155, 7510154, 7534856, 7535008, 7535009, 7411809.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1036-2026%22", "url": "https://recallledger.net/recalls/device-z-1036-2026-codman-microsensor-basic-kit-catalog-number-626631us-use-of-the/"}, {"id": "fda-device-z-1034-2026", "source": "FDA", "category": "device", "recall_number": "Z-1034-2026", "title": "Brand Name: HFD100  Product Name: Head Fixation Device HFD100  Model/Catalog Number:... recall (IMRIS Imaging Inc)", "product": "Brand Name: HFD100  Product Name: Head Fixation Device HFD100  Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600  Software Version: Not Applicable  Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while  introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore.  Component: Not a component.", "reason": "Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.", "hazard_level": "Class II", "company": "IMRIS Imaging Inc", "company_location": "Chaska, MN, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.", "states": [], "nationwide": true, "quantity": "122", "codes": "Affected UDI-DI: 00857534006011 00857534006592 00857534006608 00857534006615  Affected serial numbers:  10006206 10005998 10003999 10004026 10003796 10003811 10006629 10006630 10007514 10007515 10002486 10003048 10004215 10004216 10003794 10004231 10012064 10012310 10012311 10010990 10011142 10007914 10007971 10002391 10002969 10009132 10010058 10011570 10005134 10005711 10009569 10009878 10010057 10003903 10003906 10003546 10006187 10012838 10010639 10010666 10011925 10006692 10007246 10011463 10005092 10007237 10007509 10008416 10003407 10003793 10004195 10004975 10004993 10005136 10010381 10007906 10013179 10007510 10007511 10007245 10004449 10004961 10005849 10005851 10010747 10006730 10011187 10011307 10009593 10010003 10008073 10008354 10011546 10011571 10006207 10012127 10006631 10007777 10006411 10004466 10005445 10011645 10009015 10004291 10003985 10003987 10006204 10006205 10007235 10007236 10006412 10004775 10004323 10004942 10003936 10003937 10007130 10002695 10007126 10007128 10009228 10009210 10009583 10005480 10005481 10012839 10008645 10008670 10006693 10006694 10004317 10002403 10004673 10004671 10010572 10006212 10006203 10002968 10002715 10011186 10011265 10010059", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2026%22", "url": "https://recallledger.net/recalls/device-z-1034-2026-brand-name-hfd100-product-name-head-fixation-device-hfd100-model-c/"}, {"id": "fda-device-z-1033-2026", "source": "FDA", "category": "device", "recall_number": "Z-1033-2026", "title": "Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. recall (Philips North America Llc)", "product": "Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.", "reason": "It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.", "hazard_level": "Class II", "company": "Philips North America Llc", "company_location": "Cambridge, MA, United States", "date": "2025-12-12", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "US Nationwide distribution.", "states": [], "nationwide": true, "quantity": "13,470 Units", "codes": "Model No. 867216; UDI [Serial No.]: , (01)00884838099876(21)DK32800791[DK32800791], (01)00884838099876(21)DK32800825[DK32800825], (01)00884838099876(21)DK32800918[DK32800918], (01)00884838099876(21)DK32800947[DK32800947], (01)00884838099876(21)DK32801055[DK32801055], (01)00884838099876(21)DK32801076[DK32801076], (01)00884838099876(21)DK32801098[DK32801098], (01)00884838099876(21)DK32801120[DK32801120], (01)00884838099876(21)DK32801188[DK32801188], (01)00884838099876(21)DK32801197[DK32801197], (01)00884838099876(21)DK32801225[DK32801225], (01)00884838099876(21)DK32801235[DK32801235], (01)00884838099876(21)DK32801252[DK32801252], (01)00884838099876(21)DK32801306[DK32801306], (01)00884838099876(21)DK32801338[DK32801338], (01)00884838099876(21)DK33402127[DK33402127], (01)00884838099876(21)DK33402141[DK33402141], (01)00884838099876(21)DK33402210[DK33402210], (01)00884838099876(21)DK33402281[DK33402281], (01)00884838099876(21)DK33402309[DK33402309], (01)00884838099876(21)DK33402345[DK33402345], (01)00884838099876(21)DK33402358[DK33402358], (01)00884838099876(21)DK33402363[DK33402363], (01)00884838099876(21)DK33402364[DK33402364], (01)00884838099876(21)DK33402437[DK33402437], (01)00884838099876(21)DK33402526[DK33402526], (01)00884838099876(21)DK33402553[DK33402553], (01)00884838099876(21)DK33402569[DK33402569], (01)00884838099876(21)DK33402630[DK33402630], (01)00884838099876(21)DK33402653[DK33402653], (01)00884838099876(21)DK33402657[DK33402657], (01)00884838099876(21)DK33402737[DK33402737], (01)00884838099876(21)DK33402805[DK33402805], (01)00884838099876(21)DK33402894[DK33402894], (01)00884838099876(21)DK33402955[DK33402955], (01)00884838099876(21)DK33403058[DK33403058], (01)00884838099876(21)DK33403144[DK33403144], (01)00884838099876(21)DK33403145[DK33403145], (01)00884838099876(21)DK33403209[DK33403209], (01)00884838099876(21)DK33403222[DK33403222], (01)00884838099876(21)DK33403235[DK33403235], (01)00884838099876(21)DK33603488[DK33603488], (01)00884838099876(21)DK33603527[DK33603527], (01)00884838099876(21)DK33603582[DK33603582], (01)00884838099876(21)DK33603584[DK33603584], (01)00884838099876(21)DK33603673[DK33603673], (01)00884838099876(21)DK33603678[DK33603678], (01)00884838099876(21)DK33603746[DK33603746], (01)00884838099876(21)DK33603796[DK33603796], (01)00884838099876(21)DK33603971[DK33603971], (01)00884838099876(21)DK33603989[DK33603989], (01)00884838099876(21)DK33603999[DK33603999], (01)00884838099876(21)DK33604020[DK33604020], (01)00884838099876(21)DK33604046[DK33604046], (01)00884838099876(21)DK33604057[DK33604057], (01)00884838099876(21)DK33604109[DK33604109], (01)00884838099876(21)DK33604128[DK33604128], (01)00884838099876(21)DK33604162[DK33604162], (01)00884838099876(21)DK33604229[DK33604229], (01)00884838099876(21)DK33604235[DK33604235], (01)00884838099876(21)DK33604249[DK33604249], (01)00884838099876(21)DK33604252[DK33604252], (01)00884838099876(21)DK33604424[DK33604424], (01)00884838099876(21)DK33604425[DK33604425], (01)00884838099876(21)DK33604524[DK33604524], (01)00884838099876(21)DK33604571[DK33604571], (01)00884838099876(21)DK33604588[DK33604588], (01)00884838099876(21)DK33604612[DK33604612], (01)00884838099876(21)DK33904737[DK33904737], (01)00884838099876(21)DK33904802[DK33904802], (01)00884838099876(21)DK33904818[DK33904818], (01)00884838099876(21)DK33904830[DK33904830], (01)00884838099876(21)DK33904834[DK33904834], (01)00884838099876(21)DK33904949[DK33904949], (01)00884838099876(21)DK33904961[DK33904961], (01)00884838099876(21)DK33905053[DK33905053], (01)00884838099876(21)DK33905076[DK33905076], (01)00884838099876(21)DK33905149[DK33905149], (01)00884838099876(21)DK34305222[DK34305222], (01)00884838099876(21)DK34305227[DK34305227], (01)00884838099876(21)DK34305256[DK34305256], (01)00884838099876(21)DK34405461[DK34405461], (01)00884838099876(21)DK34405464[DK34405464], (01)00884838099876(21)DK34405673[DK34405673], (01)00884838099876(21)DK34405777[DK34405777], (01)00884838099876(21)DK34405778[DK34405778], (01)00884838099876(21)DK34405795[DK34405795], (01)00884838099876(21)DK34706009[DK34706009], (01)00884838099876(21)DK34706048[DK34706048], (01)00884838099876(21)DK34706100[DK34706100], (01)00884838099876(21)DK34706116[DK34706116], (01)00884838099876(21)DK34706181[DK34706181], (01)00884838099876(21)DK34706271[DK34706271], (01)00884838099876(21)DK34706308[DK34706308], (01)00884838099876(21)DK34706385[DK34706385], (01)00884838099876(21)DK34706394[DK34706394], (01)00884838099876(21)DK34706485[DK34706485], (01)00884838099876(21)DK40306620[DK40306620], (01)00884838099876(21)DK40306621[DK40306621], (01)00884838099876(21)DK40306622[DK40306622], (01)00884838099876(21)DK40306681[DK40306681], (01)00884838099876(21)DK40306690[DK40306690], (01)00884838099876(21)DK40306709[DK40306709], (01)00884838099876(21)DK40306749[DK40306749], (01)00884838099876(21)DK40306765[DK40306765], (01)00884838099876(21)DK40306766[DK40306766], (01)00884838099876(21)DK40306781[DK40306781], (01)00884838099876(21)DK40306796[DK40306796], (01)00884838099876(21)DK40306831[DK40306831], (01)00884838099876(21)DK40306838[DK40306838], (01)00884838099876(21)DK40306870[DK40306870], (01)00884838099876(21)DK40306898[DK40306898], (01)00884838099876(21)DK40306958[DK40306958], (01)00884838099876(21)DK40307021[DK40307021], (01)00884838099876(21)DK40307048[DK40307048], (01)00884838099876(21)DK40307129[DK40307129], (01)00884838099876(21)DK40707316[DK40707316], (01)00884838099876(21)DK40707339[DK40707339], (01)00884838099876(21)DK40707345[DK40707345], (01)00884838099876(21)DK40707357[DK40707357], (01)00884838099876(21)DK40707358[DK40707358], (01)00884838099876(21)DK40707371[DK40707371], (01)00884838099876(21)DK40707379[DK40707379], (01)00884838099876(21)DK40707386[DK40707386], (01)00884838099876(21)DK40707419[DK40707419], (01)00884838099876(21)DK40707604[DK40707604], (01)00884838099876(21)DK40707668[DK40707668], (01)00884838099876(21)DK40707670[DK40707670], (01)00884838099876(21)DK40707685[DK40707685], (01)00884838099876(21)DK40707703[DK40707703], (01)00884838099876(21)DK40707802[DK40707802], (01)00884838099876(21)DK40707892[DK40707892], (01)00884838099876(21)DK40707904[DK40707904], (01)00884838099876(21)DK40707917[DK40707917], (01)00884838099876(21)DK40907983[DK40907983], (01)00884838099876(21)DK40908048[DK40908048], (01)00884838099876(21)DK40908094[DK40908094], (01)00884838099876(21)DK40908104[DK40908104], (01)00884838099876(21)DK40908186[DK40908186], (01)00884838099876(21)DK40908203[DK40908203], (01)00884838099876(21)DK40908211[DK40908211], (01)00884838099876(21)DK40908212[DK40908212], (01)00884838099876(21)DK40908228[DK40908228], (01)00884838099876(21)DK40908234[DK40908234], (01)00884838099876(21)DK40908246[DK40908246], (01)00884838099876(21)DK40908253[DK40908253], (01)00884838099876(21)DK40908259[DK40908259], (01)00884838099876(21)DK40908260[DK40908260], (01)00884838099876(21)DK40908346[DK40908346], (01)00884838099876(21)DK40908356[DK40908356], (01)00884838099876(21)DK40908363[DK40908363], (01)00884838099876(21)DK40908364[DK40908364], (01)00884838099876(21)DK40908406[DK40908406], (01)00884838099876(21)DK40908432[DK40908432], (01)00884838099876(21)DK40908475[DK40908475], (01)00884838099876(21)DK40908486[DK40908486], 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"https://recallledger.net/recalls/device-z-1033-2026-philips-smart-hopping-2-0-ap-1-4-ghz-patient-monitor/"}, {"id": "fda-device-z-1032-2026", "source": "FDA", "category": "device", "recall_number": "Z-1032-2026", "title": "Arial 900 MHz Call Station recall (Securitas Healthcare LLC)", "product": "Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3", "reason": "Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.", "hazard_level": "Class II", "company": "Securitas Healthcare LLC", "company_location": "Lincoln, NE, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide distribution -US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "1898 units", "codes": "All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024.  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"fda-device-z-1031-2026", "source": "FDA", "category": "device", "recall_number": "Z-1031-2026", "title": "Arial 900 MHz Call Station recall (Securitas Healthcare LLC)", "product": "Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3", "reason": "Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.", "hazard_level": "Class II", "company": "Securitas Healthcare LLC", "company_location": "Lincoln, NE, United States", "date": "2025-12-08", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide distribution -US Nationwide and the country of Canada.", "states": [], "nationwide": true, "quantity": "5627 units", "codes": "All units of the Affected Device Models sold between January 1st, 2023 and June 26th, 2024.  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the country of Australia and Taiwan.", "states": [], "nationwide": false, "quantity": "6 units", "codes": "Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2026%22", "url": "https://recallledger.net/recalls/device-z-1030-2026-impella-5-5-with-smartassist-s2-impella-5-5-with-smartassist-s2-set/"}, {"id": "fda-device-z-1028-2026", "source": "FDA", "category": "device", "recall_number": "Z-1028-2026", "title": "BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 recall (CareFusion 303, Inc.)", "product": "BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03  137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01  139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03  139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01    Software Versions:  System Versions 1.6.1 - 1.11.0  Server Application Versions ES 5.4X - 5.8.X    The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.", "reason": "Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.", "hazard_level": "Class II", "company": "CareFusion 303, Inc.", "company_location": "San Diego, CA, United States", "date": "2025-12-03", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, and WY. The countries of Bermuda, and Canada.", "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": "2,079 systems", "codes": "Catalog Number: 1115-00 Software Versions: UDI-DI code for Hardware: 10885403518348 UDI-DI code for Software: 10885403520341 System Versions 1.6.1 - 1.11.0 Server Application Versions ES 4.13 - 5.8.X", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2026%22", "url": "https://recallledger.net/recalls/device-z-1028-2026-bd-pyxis-es-enterprise-server-catalog-numbers-1115-00-137672-02-13767/"}, {"id": "fda-device-z-1019-2026", "source": "FDA", "category": "device", "recall_number": "Z-1019-2026", "title": "Revogene C. difficile recall (Meridian Bioscience Inc)", "product": "Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300", "reason": "The affected lots show a decline in performance over time, which may lead to false-negative results.", "hazard_level": "Class II", "company": "Meridian Bioscience Inc", "company_location": "Cincinnati, OH, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "US Nationwide distribution and the OUS country of Italy.", "states": [], "nationwide": true, "quantity": "211 units", "codes": "UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2026%22", "url": "https://recallledger.net/recalls/device-z-1019-2026-revogene-c-difficile-in-vitro-diagnostic-assay-intended-for-use-with/"}, {"id": "fda-device-z-1010-2026", "source": "FDA", "category": "device", "recall_number": "Z-1010-2026", "title": "Kii Low Profile recall (Applied Medical Resources Corp)", "product": "Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm  REF: CTB23", "reason": "There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.", "hazard_level": "Class II", "company": "Applied Medical Resources Corp", "company_location": "Rancho Santa Margarita, CA, United States", "date": "2025-12-11", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "US: MI, CA, ME,  OUS: France Great Britain, Germany", "states": ["CA", "ME", "MI"], "nationwide": false, "quantity": "450 units", "codes": "UDI: (01)00607915126582; Lot # 1546141", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2026%22", "url": "https://recallledger.net/recalls/device-z-1010-2026-kii-low-profile-bladed-dual-pack-qty-1-5x55mm-ref-ctb23/"}, {"id": "fda-device-z-1003-2026", "source": "FDA", "category": "device", "recall_number": "Z-1003-2026", "title": "Philips Incisive CT recall (Philips Healthcare (Suzhou) Co., Ltd.)", "product": "Philips Incisive CT", "reason": "Potential for incomplete scan due to unstable connection inside of floating sensor.", "hazard_level": "Class II", "company": "Philips Healthcare (Suzhou) Co., Ltd.", "company_location": "Suzhou, China", "date": "2025-12-03", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S. and U.S. territories", "states": [], "nationwide": false, "quantity": "35", "codes": "", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2026%22", "url": "https://recallledger.net/recalls/device-z-1003-2026-philips-incisive-ct/"}, {"id": "fda-device-z-0999-2026", "source": "FDA", "category": "device", "recall_number": "Z-0999-2026", "title": "LUMINOS Lotus Max recall (Siemens Medical Solutions USA, Inc)", "product": "LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471", "reason": "A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max  systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When  switching quickly between organ programs (OGPs) the collimation may be incorrect.", "hazard_level": "Class II", "company": "Siemens Medical Solutions USA, Inc", "company_location": "Malvern, PA, United States", "date": "2025-12-05", "report_date": "2026-01-14", "status": "Ongoing", "distribution": "U.S. and OUS", "states": [], "nationwide": false, "quantity": "U.S.: 1, OUS: 95", "codes": "(01)04056869269931(21)10330", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2026%22", "url": "https://recallledger.net/recalls/device-z-0999-2026-luminos-lotus-max-model-11574100-and-luminos-drf-max-model-10762471/"}, {"id": "fda-food-h-0391-2026", "source": "FDA", "category": "food", "recall_number": "H-0391-2026", "title": "Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is... recall (Tom Bumble LLC)", "product": "Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is shelf stable, gold foil wrapping with paper label and cardboard outer box in some cases. Oregon Bark 2630 NE Sandy Blvd. Portland, Oregon 97232  2 Bars Boxes marked  50/50  or  Nutty  4 Bars Boxes marked  50/50 or  NUTTY  24 count boxes labeled  Nutty   UPC 852905007024 (1.2oz)  UPC 852905007055 (2.2oz)  UPC 852905007031 (4.5oz)", "reason": "Foreign material.", "hazard_level": "Class II", "company": "Tom Bumble LLC", "company_location": "Portland, OR, United States", "date": "2025-12-13", "report_date": "2026-01-07", "status": "Terminated", "distribution": "Distributed nationwide", "states": [], "nationwide": true, "quantity": "Approx. 6500 units", "codes": "Best By dates between 5/21/26 - 6/9/26.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0391-2026%22", "url": "https://recallledger.net/recalls/food-h-0391-2026-tom-bumble-nutty-peanut-butter-flake-candy-with-peanut-chocolate-gf/"}, {"id": "fda-food-h-0350-2026", "source": "FDA", "category": "food", "recall_number": "H-0350-2026", "title": "1) Paw Patrol Heart-Shaped Gummy Candies recall (Bendon Publishing)", "product": "1) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc.  2) Mickey Mouse Heart-Shaped Gummies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643853, Distributed by Bendon, Inc.  3) Stitch Heart-Shaped Gummies, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643860, Distributed by Bendon, Inc.  4) SpongeBob Squarepants Heart-Shaped Gummy Candy, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219644225, Distributed by Bendon, Inc.  5) Toy Story Multipack Size Gummies, Mixed Fruit, Net Wt. 6.35 oz (180g), packaged in a plastic bag containing 20 mini size packs (0.4 oz each), UPC 805219643914, Distributed by Bendon, Inc.", "reason": "Unapproved color additive - chlorophyllin copper complex", "hazard_level": "Class III", "company": "Bendon Publishing", "company_location": "Ashland, OH, United States", "date": "2025-12-03", "report_date": "2026-01-07", "status": "Terminated", "distribution": "Distributors in FL, MN, TX, WA", "states": ["FL", "MN", "TX", "WA"], "nationwide": false, "quantity": "39,171 individual units (TOTAL)", "codes": "1) Lot# 3514-8A; Best Before 08/19/2027; Internal Item#: PC64384-WMPDQ 2) Lot# 3514-8B; Best Before 08/19/2027; Internal Item#: PC64385-WMPDQ 3) Lot# 3514-8C; Best Before 08/19/2027; Internal Item#: PC64386-WMPDQ 4) Lot# 3514-8D; Best Before 08/19/2027; Internal Item#: PC64422-WMPDQ 5) Lot# 3514-8E; Best Before 08/19/2027; Internal Item#: PC64391-WMPDQ", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0350-2026%22", "url": "https://recallledger.net/recalls/food-h-0350-2026-1-paw-patrol-heart-shaped-gummy-candies-mixed-fruit-net-wt-7-oz-2/"}, {"id": "fda-drug-d-0247-2026", "source": "FDA", "category": "drug", "recall_number": "D-0247-2026", "title": "traZODONE Hydrochloride Tablets recall (Zydus Pharmaceuticals (USA) Inc)", "product": "traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10", "reason": "Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.", "hazard_level": "Class III", "company": "Zydus Pharmaceuticals (USA) Inc", "company_location": "Pennington, NJ, United States", "date": "2025-12-19", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "2,136 1000-count bottles", "codes": "Lot # EA00237A, Exp Date: 04/30/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2026%22", "url": "https://recallledger.net/recalls/drug-d-0247-2026-trazodone-hydrochloride-tablets-usp-100mg-1-000-tablets-rx-only-m/"}, {"id": "fda-drug-d-0246-2026", "source": "FDA", "category": "drug", "recall_number": "D-0246-2026", "title": "Ondansetron Orally Disintegrating Tablets recall (Glenmark Pharmaceuticals Inc., USA)", "product": "Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13", "reason": "Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.", "hazard_level": "Class II", "company": "Glenmark Pharmaceuticals Inc., USA", "company_location": "Elmwood Park, NJ, United States", "date": "2025-12-30", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "96,948 packs", "codes": "Lot #: 19251311, Exp Date April 2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2026%22", "url": "https://recallledger.net/recalls/drug-d-0246-2026-ondansetron-orally-disintegrating-tablets-usp-4mg-30-tablets-3-bli/"}, {"id": "fda-drug-d-0245-2026", "source": "FDA", "category": "drug", "recall_number": "D-0245-2026", "title": "Wegovy recall (Novo Nordisk Inc.)", "product": "Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14", "reason": "Presence of Particulate Matter: Hair was found in a prefilled syringe", "hazard_level": "Class II", "company": "Novo Nordisk Inc.", "company_location": "Plainsboro, NJ, United States", "date": "2025-12-19", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "Nationwide within the United States.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2026%22", "url": "https://recallledger.net/recalls/drug-d-0245-2026-wegovy-semaglutide-injection-1-mg-0-5-ml-4-single-dose-prefilled-p/"}, {"id": "fda-drug-d-0244-2026", "source": "FDA", "category": "drug", "recall_number": "D-0244-2026", "title": "Wegovy recall (Novo Nordisk Inc.)", "product": "Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14", "reason": "Presence of Particulate Matter: Hair was found in a prefilled syringe", "hazard_level": "Class II", "company": "Novo Nordisk Inc.", "company_location": "Plainsboro, NJ, United States", "date": "2025-12-19", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "Nationwide within the United States.", "states": [], "nationwide": true, "quantity": "N/A", "codes": "Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0244-2026%22", "url": "https://recallledger.net/recalls/drug-d-0244-2026-wegovy-semaglutide-injection-0-5-mg-0-5-ml-4-single-dose-prefilled/"}, {"id": "fda-drug-d-0243-2026", "source": "FDA", "category": "drug", "recall_number": "D-0243-2026", "title": "BD ChloraPrep\" Triple Swabsticks recall (CareFusion 213, LLC)", "product": "BD ChloraPrep\" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29", "reason": "Lack of Assurance of Sterlity", "hazard_level": "Class II", "company": "CareFusion 213, LLC", "company_location": "El Paso, TX, United States", "date": "2025-12-17", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "106,400 units", "codes": "Lot #: 5086623, Exp. Date 03/31/2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0243-2026%22", "url": "https://recallledger.net/recalls/drug-d-0243-2026-bd-chloraprep-triple-swabsticks-chlorhexidine-gluconate-chg-2-w/"}, {"id": "fda-device-z-1008-2026", "source": "FDA", "category": "device", "recall_number": "Z-1008-2026", "title": "BVI Leos Laser and Endoscopy System. Model Number: OME6000U. recall (Beaver-Visitec International, Inc.)", "product": "BVI Leos Laser and Endoscopy System. Model Number: OME6000U.", "reason": "Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).", "hazard_level": "Class II", "company": "Beaver-Visitec International, Inc.", "company_location": "Waltham, MA, United States", "date": "2025-12-05", "report_date": "2026-01-07", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of FL, MI, OK, TX, WI.", "states": ["FL", "MI", "OK", "TX", "WI"], "nationwide": true, "quantity": "5 units", "codes": "Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2026%22", "url": "https://recallledger.net/recalls/device-z-1008-2026-bvi-leos-laser-and-endoscopy-system-model-number-ome6000u/"}, {"id": "fda-food-h-0337-2026", "source": "FDA", "category": "food", "recall_number": "H-0337-2026", "title": "1) Wegmans Deluxe Mixed Nuts recall (Mellace Family Brands California Inc)", "product": "1) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 34 oz. (964g), packaged in a plastic tub with UPC 077890421314, packed 6 tubs per case  2) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 11.5 oz. (326g), packaged in a plastic bag with UPC 077890421352, packed 12 bags per case", "reason": "Potential contamination with Salmonella", "hazard_level": "Class I", "company": "Mellace Family Brands California Inc", "company_location": "Warren, OH, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Terminated", "distribution": "Distributors in PA and NY", "states": ["NY", "PA"], "nationwide": false, "quantity": "3,024 units (438 cases)", "codes": "1) Lot: 58041; Best If Used By: JUL 28 2026; Internal Product Code: 84695  2) Lot: 58171; Best If Used By: AUG 10 2026; Internal Product Code: 84696", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0337-2026%22", "url": "https://recallledger.net/recalls/food-h-0337-2026-1-wegmans-deluxe-mixed-nuts-unsalted-net-wt-34-oz-964g-package/"}, {"id": "fda-food-h-0330-2026", "source": "FDA", "category": "food", "recall_number": "H-0330-2026", "title": "Publix Raspberry Coffee Cake recall (The James Skinner LLC)", "product": "Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound label, UPC 0-41415-54691-2, Distributed By Publix Supermarkets, Inc. Lakeland, FL 33802, packed 12 per case  Case label reads, in part: Maple Walnut Coffee Cake, 12 units/14 oz. each, Net Wt. 10.5 LB (4.6 kg), UPC 100 41415 54591 2", "reason": "Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.", "hazard_level": "Class II", "company": "The James Skinner LLC", "company_location": "Omaha, NE, United States", "date": "2025-12-10", "report_date": "2025-12-31", "status": "Terminated", "distribution": "Product shipped to one distributor in FL: Sourcing and Distribution Specialist Winter Haven, FL 33880", "states": ["FL"], "nationwide": false, "quantity": "811 cases", "codes": "Product Lot Number: 5309 Expiration Date on Case: 5 1 04 FRZ EXP 110526", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0330-2026%22", "url": "https://recallledger.net/recalls/food-h-0330-2026-publix-raspberry-coffee-cake-net-wt-15-oz-425g-packaged-in-an-al/"}, {"id": "fda-food-h-0326-2026", "source": "FDA", "category": "food", "recall_number": "H-0326-2026", "title": "Grandma Belle's Tomato Basil Soup recall (Lil Turtles LLC)", "product": "Grandma Belle's Tomato Basil Soup, Net Wt. 17 oz. (482g), packaged in a glass jar, UPC 810084612293, Made By: Lil' Turtles 504 North Ray Street, Baltic, Ohio 43804, packed 12 jars per case", "reason": "Undeclared allergen - milk", "hazard_level": "Class II", "company": "Lil Turtles LLC", "company_location": "Baltic, OH, United States", "date": "2025-12-04", "report_date": "2025-12-31", "status": "Terminated", "distribution": "IA, IL, IN, KS, KY, MN, MO, MS, NY, OH, OK, PA, UT, WI", "states": ["IA", "IL", "IN", "KS", "KY", "MN", "MO", "MS", "NY", "OH", "OK", "PA", "UT", "WI"], "nationwide": false, "quantity": "110 cases", "codes": "Product Code: 21495 Best By Date: 09-22-2024 through 06-03-2028", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0326-2026%22", "url": "https://recallledger.net/recalls/food-h-0326-2026-grandma-belle-s-tomato-basil-soup-net-wt-17-oz-482g-packaged-in/"}, {"id": "fda-drug-d-0242-2026", "source": "FDA", "category": "drug", "recall_number": "D-0242-2026", "title": "Noxafil Powdermix recall (Merck Sharp & Dohme LLC)", "product": "Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.", "reason": "Presence of particulate matter: potential presence of metal particulates in the product.", "hazard_level": "Class II", "company": "Merck Sharp & Dohme LLC", "company_location": "Wilson, NC, United States", "date": "2025-12-12", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "845 kits", "codes": "Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0242-2026%22", "url": "https://recallledger.net/recalls/drug-d-0242-2026-noxafil-powdermix-posaconazole-for-delayed-release-oral-suspension/"}, {"id": "fda-drug-d-0241-2026", "source": "FDA", "category": "drug", "recall_number": "D-0241-2026", "title": "Merck Emend recall (Merck Sharp & Dohme LLC)", "product": "Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by:  Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03", "reason": "Presence of particulate matter: potential presence of metal particulates in the product.", "hazard_level": "Class II", "company": "Merck Sharp & Dohme LLC", "company_location": "Wilson, NC, United States", "date": "2025-12-12", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "Nationwide in the USA", "states": [], "nationwide": true, "quantity": "3 - single dose kits", "codes": "Lot #: Z014503, Exp 11/15/2027", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0241-2026%22", "url": "https://recallledger.net/recalls/drug-d-0241-2026-merck-emend-aprepitant-for-oral-suspension-125-mg-single-dose-kit/"}, {"id": "fda-device-z-0986-2026", "source": "FDA", "category": "device", "recall_number": "Z-0986-2026", "title": "LYFO DISK recall (Microbiologics Inc)", "product": "LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L", "reason": "Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.", "hazard_level": "Class II", "company": "Microbiologics Inc", "company_location": "Saint Cloud, MN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "Worldwide - US Nationwide.", "states": [], "nationwide": true, "quantity": "1 unit (16 additional units added 12/22/25)", "codes": "UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0986-2026%22", "url": "https://recallledger.net/recalls/device-z-0986-2026-lyfo-disk-campylobacter-jejuni-subsp-jejuni-derived-from-atcc-29428/"}, {"id": "fda-device-z-0985-2026", "source": "FDA", "category": "device", "recall_number": "Z-0985-2026", "title": "KWIK-STIK 6-Pack recall (Microbiologics Inc)", "product": "KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K", "reason": "Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.", "hazard_level": "Class II", "company": "Microbiologics Inc", "company_location": "Saint Cloud, MN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "Worldwide - US Nationwide.", "states": [], "nationwide": true, "quantity": "18 units (9 additional units 12/22/25)", "codes": "UDI-DI: 30845357006463; Lot Numbers: 325-120-1, 325-120-4, 325-120-6, Additional Lots added 12/22/25: 325-119-2", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0985-2026%22", "url": "https://recallledger.net/recalls/device-z-0985-2026-kwik-stik-6-pack-campylobacter-jejuni-subsp-jejuni-derived-from-atcc/"}, {"id": "fda-device-z-0984-2026", "source": "FDA", "category": "device", "recall_number": "Z-0984-2026", "title": "KWIK-STIK 2-Pack recall (Microbiologics Inc)", "product": "KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P", "reason": "Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.", "hazard_level": "Class II", "company": "Microbiologics Inc", "company_location": "Saint Cloud, MN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "Worldwide - US Nationwide.", "states": [], "nationwide": true, "quantity": "86 units (127 additional units 12/22/25)", "codes": "UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2026%22", "url": "https://recallledger.net/recalls/device-z-0984-2026-kwik-stik-2-pack-campylobacter-jejuni-subsp-jejuni-derived-from-atcc/"}, {"id": "fda-device-z-0983-2026", "source": "FDA", "category": "device", "recall_number": "Z-0983-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "11", "codes": "Lot Code: Model No 815509300 ; UDI-DI (01)00887868143519(17)340823(10)66717550 ; Lot Number 66717550", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0983-2026%22", "url": "https://recallledger.net/recalls/device-z-0983-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0982-2026", "source": "FDA", "category": "device", "recall_number": "Z-0982-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "3", "codes": "Lot Code: Model No 815809280 ; UDI-DI (01)00887868584763(17)350416(10)67066287 ; Lot Number 67066287", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0982-2026%22", "url": "https://recallledger.net/recalls/device-z-0982-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0981-2026", "source": "FDA", "category": "device", "recall_number": "Z-0981-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "24", "codes": "Lot Code: Model No 815609440 ; UDI-DI (01)00887868144530(17)340819(10)66717607; Lot Number 66717607 Model No 815609440 ; UDI-DI (01)00887868144530(17)341025(10)67031553 ; Lot Number 67031553", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0981-2026%22", "url": "https://recallledger.net/recalls/device-z-0981-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0980-2026", "source": "FDA", "category": "device", "recall_number": "Z-0980-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "23", "codes": "Lot Code: Model No 815609420 ; UDI-DI (01)00887868144523(17)340818(10)66717606 ; Lot Number 66717606 Model No 815609420 ; UDI-DI (01)00887868144523(17)340913(10)66892905 ; Lot Number 66892905", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0980-2026%22", "url": "https://recallledger.net/recalls/device-z-0980-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0979-2026", "source": "FDA", "category": "device", "recall_number": "Z-0979-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "24", "codes": "Lot Code: Model No 815609400 ; UDI-DI (01)00887868144516(17)340818(10)66717605 ; Lot Number 66717605 Model No 815609400 ; UDI-DI (01)00887868144516(17)340826(10)66892904 ; Lot Number 66892904 Model No 815609400 ; UDI-DI (01)00887868144516(17)341024(10)67031552 ; Lot Number 67031552", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0979-2026%22", "url": "https://recallledger.net/recalls/device-z-0979-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0978-2026", "source": "FDA", "category": "device", "recall_number": "Z-0978-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "24", "codes": "Lot Code: Model No 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380 ; UDI-DI (01)00887868144509(17)340820(10)66892903 ; Lot Number 66892903", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2026%22", "url": "https://recallledger.net/recalls/device-z-0978-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0977-2026", "source": "FDA", "category": "device", "recall_number": "Z-0977-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "24", "codes": "Lot Code: Model No 815609360 ; UDI-DI (01)00887868144493(17)340820(10)66717603 ; Lot Number 66717603 Model No 815609360 ; UDI-DI (01)00887868144493(17)340905(10)66892902 ; Lot Number 66892902 Model No 815609360 ; UDI-DI (01)00887868144493(17)341030(10)67031550 ; Lot Number 67031550", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0977-2026%22", "url": "https://recallledger.net/recalls/device-z-0977-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0976-2026", "source": "FDA", "category": "device", "recall_number": "Z-0976-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "24", "codes": "Lot Code: Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66717602 ; Lot Number 66717602 Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66892901 ; Lot Number 66892901", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0976-2026%22", "url": "https://recallledger.net/recalls/device-z-0976-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0975-2026", "source": "FDA", "category": "device", "recall_number": "Z-0975-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "23", "codes": "Lot Code: Model No 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320 ; UDI-DI (01)00887868144479(17)340820(10)66892900 ; Lot Number 66892900", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0975-2026%22", "url": "https://recallledger.net/recalls/device-z-0975-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0974-2026", "source": "FDA", "category": "device", "recall_number": "Z-0974-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "11", "codes": "Lot Code: Model No 815609300 ; UDI-DI (01)00887868144462(17)340826(10)66717600 ; Lot Number 66717600", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0974-2026%22", "url": "https://recallledger.net/recalls/device-z-0974-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0973-2026", "source": "FDA", "category": "device", "recall_number": "Z-0973-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "22", "codes": "Lot Code: Model No 815509440 ; UDI-DI (01)00887868143588(17)340820(10)66717557 ; Lot Number 66717557 Model No 815509440 ; UDI-DI (01)00887868143588(17)350422(10)67101279 ; Lot Number 67101279 Model No 815509440 ; UDI-DI (01)00887868143588(17)350419(10)67101280 ; Lot Number 67101280", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0973-2026%22", "url": "https://recallledger.net/recalls/device-z-0973-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0972-2026", "source": "FDA", "category": "device", "recall_number": "Z-0972-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "22", "codes": "Lot Code: Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66717556 ; Lot Number 66717556 Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66884566 ; Lot Number 66884566", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0972-2026%22", "url": "https://recallledger.net/recalls/device-z-0972-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0971-2026", "source": "FDA", "category": "device", "recall_number": "Z-0971-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "23", "codes": "Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 67379212", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0971-2026%22", "url": "https://recallledger.net/recalls/device-z-0971-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0970-2026", "source": "FDA", "category": "device", "recall_number": "Z-0970-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "23", "codes": "Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66884564 ; Lot Number 66884564 Model No 815509380 ; UDI-DI (01)00887868143557(17)350421(10)67042197 ; Lot Number 67042197", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0970-2026%22", "url": "https://recallledger.net/recalls/device-z-0970-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0969-2026", "source": "FDA", "category": "device", "recall_number": "Z-0969-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "22", "codes": "Lot Code: Model No 815509360 ; UDI-DI (01)00887868143540(17)340917(10)66717553 ; Lot Number 66717553 Model No 815509360 ; UDI-DI (01)00887868143540(17)340823(10)66884563 ; Lot Number 66884563", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0969-2026%22", "url": "https://recallledger.net/recalls/device-z-0969-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0968-2026", "source": "FDA", "category": "device", "recall_number": "Z-0968-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "22", "codes": "Lot Code: Model No 815509340 ; UDI-DI (01)00887868143533(17)340822(10)66717552 ; Lot Number 66717552 Model No 815509340 ; UDI-DI (01)00887868143533(17)340826(10)66884562 ; Lot Number 66884562", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0968-2026%22", "url": "https://recallledger.net/recalls/device-z-0968-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-device-z-0967-2026", "source": "FDA", "category": "device", "recall_number": "Z-0967-2026", "title": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade... recall (Zimmer, Inc.)", "product": "Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A", "reason": "Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.", "hazard_level": "Class II", "company": "Zimmer, Inc.", "company_location": "Warsaw, IN, United States", "date": "2025-12-02", "report_date": "2025-12-31", "status": "Ongoing", "distribution": "US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.", "states": ["AL", "AZ", "CA", "FL", "IN", "KY", "MA", "MO", "MT", "NC", "NM", "RI", "TX", "UT"], "nationwide": true, "quantity": "22", "codes": "Lot Code: Model No 815509320 ; UDI-DI (01)00887868143526(17)340820(10)66717551 ; Lot Number 66717551 Model No 815509320 ; UDI-DI (01)00887868143526(17)340821(10)66884561; Lot Number 66884561", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0967-2026%22", "url": "https://recallledger.net/recalls/device-z-0967-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-aff/"}, {"id": "fda-drug-d-0240-2026", "source": "FDA", "category": "drug", "recall_number": "D-0240-2026", "title": "Ciclopirox Shampoo recall (SUN PHARMA /TARO)", "product": "Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08", "reason": "Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint", "hazard_level": "Class II", "company": "SUN PHARMA /TARO", "company_location": "Hawthorne, NY, United States", "date": "2025-12-09", "report_date": "2025-12-24", "status": "Ongoing", "distribution": "Nationwide within the United States", "states": [], "nationwide": true, "quantity": "17,664 units", "codes": "Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.", "remedy": null, "retailers": [], "injuries": null, "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0240-2026%22", "url": "https://recallledger.net/recalls/drug-d-0240-2026-ciclopirox-shampoo-1-120-ml-rx-only-mfg-by-taro-pharmaceuticals/"}, {"id": "cpsc-26164", "source": "CPSC", "category": "consumer-product", "recall_number": "26164", "title": "Meaicezli Play Purse Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Angeer-US", "product": "Meaicezli Play Purse Sets", "reason": "The children's toy violates the mandatory standard for toys because the toy cell phone contains button cell batteries and the toy tablet contains a lithium coin battery that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.", "hazard_level": null, "company": "Qianshanshiangeerdianzishangwuyouxiangongsi doing business as Angeer-US, of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-24", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from August 2025 through October 2025 for about $15.", "states": [], "nationwide": true, "quantity": "About 3,090", "codes": "", "remedy": "Consumers should stop using the toy purse set immediately, take the toy cell phone and writing tablet away from children and contact Angeer-US for a full refund. Consumers will need to email a photograph confirming disposal of the toy cell phone and the writing tablet and send a photo to meaicezli-services@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 August 2025 through October 2025 for about $15."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Meaicezli-Play-Purse-Sets-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violates-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-Angeer-US", "url": "https://recallledger.net/recalls/product-26164-meaicezli-play-purse-sets-recalled-due-to-risk-of-serious-injury-or-de/"}, {"id": "cpsc-26163", "source": "CPSC", "category": "consumer-product", "recall_number": "26163", "title": "Blue Wave Recalls Above-Ground Pools 48 Inches and Taller Due to Drowning Hazard", "product": "Blue Wave brand 48-inch and taller above-ground pools", "reason": "The compression strap that surrounds the outside of the pool legs may create a foothold, allowing a child access to the pool, posing a drowning risk.", "hazard_level": null, "company": "Blue Wave Products Inc., of Batavia, Illinois", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at The Home Depot, Lowe's, and Dunham's Sports retail stores nationwide and online at Amazon.com, Walmart.com, Wayfair.com from January 2021 through July 2025 for between $600 and $2,000 depending on the size and model of the pool and accessories purchased.", "states": [], "nationwide": true, "quantity": "About 13,400", "codes": "", "remedy": "Consumers should contact Blue Wave to request a free repair kit. In the interim, consumers should ensure that children cannot access the pool unattended or, alternatively, drain the pool until the repair can be installed. Refund", "retailers": ["The Home Depot, Lowe's, and Dunham's Sports retail stores nationwide and online at Amazon.com, Walmart.com, Wayfair.com from January 2021 through July 2025 for between $600 and $2,000 depending on the size and model of the pool and accessories purchased."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Blue-Wave-Recalls-Above-Ground-Pools-48-Inches-and-Taller-Due-to-Drowning-Hazard", "url": "https://recallledger.net/recalls/product-26163-blue-wave-recalls-above-ground-pools-48-inches-and-taller-due-to-drown/"}, {"id": "cpsc-26162", "source": "CPSC", "category": "consumer-product", "recall_number": "26162", "title": "SereneLife Home Recalls Above-Ground Pools 48 Inches and Taller Due to Drowning Hazard", "product": "SereneLife brand 48-inch and taller above-ground pools", "reason": "This recall involves all SereneLife brand above-ground pools 48 inches and taller. Models SLPORND15 and SLPORND18 are included in this recall. Model information and the SereneLife logo are printed on the liner on the outside of the pool. The recalled above-ground pools contain a compression strap (also referred to as a reinforcing belt) that wraps around the pool on the outside of the vertical support poles, and may create a foothold, allowing a child to access the pool and drown. Children can still gain access to the pools using these footholds even if the ladder is removed. CPSC's website www.PoolSafely.gov has free, downloadable educational materials available to the public on pool safety including information on barriers, covers, alarms and other safety information.", "hazard_level": null, "company": "Sound Around Inc. dba SereneLife Home", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com, Walmart.com, Wayfair.com, Target.com and the SereneLife website (serenelifehome.com) from December 2021 through May 2025 for between $300 and $500 depending on the size and model of the pool and accessories purchased.", "states": [], "nationwide": true, "quantity": "About 80", "codes": "", "remedy": "Consumers should stop using the recalled above-ground pools immediately and contact SereneLife Home for a full refund. Consumers will need to provide photographic evidence of destruction or disposal of the product to receive a full refund from SereneLife Home. Refund", "retailers": ["Online at Amazon.com, Walmart.com, Wayfair.com, Target.com and the SereneLife website (serenelifehome.com) from December 2021 through May 2025 for between $300 and $500 depending on the size and model of the pool and accessories purchased."], "injuries": "None reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/SereneLife-Home-Recalls-Above-Ground-Pools-48-Inches-and-Taller-Due-to-Drowning-Hazard", "url": "https://recallledger.net/recalls/product-26162-serenelife-home-recalls-above-ground-pools-48-inches-and-taller-due-to/"}, {"id": "cpsc-26161", "source": "CPSC", "category": "consumer-product", "recall_number": "26161", "title": "ANNQUAN Brand Power Strips Recalled Due to Risk of Serious Injury or Death from Fire; Sold on Amazon by Hefei Juyuan Sporting Development", "product": "ANNQUAN Power Strips, Models EX-D112-05 and EX-D106-25", "reason": "The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The resulting fire can cause serious injury or death from smoke inhalation and burns.", "hazard_level": null, "company": "Hefei Juyuan Sporting Development Co., Ltd., of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from December 2023 through October 2025 for between $15 and $40.", "states": [], "nationwide": true, "quantity": "About 11,200", "codes": "", "remedy": "Consumers should immediately stop using the ANNQUAN power strips and contact Hefei Juyuan Sporting Development to receive a full refund. Refund", "retailers": ["Online at Amazon.com from December 2023 through October 2025 for between $15 and $40."], "injuries": "Hefei Juyuan Sporting Development has received seven reports of the power strips blowing a fuse. No fires or injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/ANNQUAN-Brand-Power-Strips-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Fire-Sold-on-Amazon-by-Hefei-Juyuan-Sporting-Development", "url": "https://recallledger.net/recalls/product-26161-annquan-brand-power-strips-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26160", "source": "CPSC", "category": "consumer-product", "recall_number": "26160", "title": "JOKOSIS Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation Hazards; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by JOKOSIS", "product": "JOKOSIS Portable Bed Rails", "reason": "The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, 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": "Guangshui Xie Lan Zheng Trading Co., Ltd., dba JOKOSIS, of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from August 2025 through November 2025 for between $40 to $50.", "states": [], "nationwide": true, "quantity": "About 12,000", "codes": "", "remedy": "Consumers should immediately stop using the JOKOSIS Bed Rails and contact JOKOSIS for a refund. Consumers should write \"RECALLED\" on the upper and lower rails with permanent marker, take a photo of the marked bed rails and email the photo to jokosisbedrailrecall@outlook.com. Consumers should then dispose of the recalled product in accordance with state and local waste disposal procedure. Refund", "retailers": ["Online at Amazon.com from August 2025 through November 2025 for between $40 to $50."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/JOKOSIS-Adult-Portable-Bed-Rails-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Entrapment-and-Asphyxiation-Hazards-Violates-Mandatory-Standard-for-Adult-Portable-Bed-Rails-Sold-on-Amazon-by-JOKOSIS", "url": "https://recallledger.net/recalls/product-26160-jokosis-adult-portable-bed-rails-recalled-due-to-risk-of-serious-injur/"}, {"id": "cpsc-26159", "source": "CPSC", "category": "consumer-product", "recall_number": "26159", "title": "KKL Fabric 9-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units; Sold on Amazon by HK Brilliant", "product": "KKL Fabric 9-Drawer Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.", "hazard_level": null, "company": "Changzhou Municipal Sea Metal Products Co. Ltd., of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2023 through November 2025 for about $100.", "states": [], "nationwide": true, "quantity": "About 4,740", "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 HK Brilliant for instructions on how to dispose of the dressers to receive a full refund. Consumers must submit a photo to support-us@kkl-home.com demonstrating disposal of the product. Refund", "retailers": ["Online at Amazon.com from September 2023 through November 2025 for about $100."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/KKL-Fabric-9-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violate-Mandatory-Standard-for-Clothing-Storage-Units-Sold-on-Amazon-by-HK-Brilliant", "url": "https://recallledger.net/recalls/product-26159-kkl-fabric-9-drawer-dressers-recalled-due-to-risk-of-serious-injury-or/"}, {"id": "cpsc-26158", "source": "CPSC", "category": "consumer-product", "recall_number": "26158", "title": "Feel The Beard Recalls Minoxidil Beard Growth Serum Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging", "product": "Feel The Beard Minoxidil Beard Growth Oil for Men", "reason": "The beard serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.", "hazard_level": null, "company": "", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from April 2025 through September 2025 for about $10.", "states": [], "nationwide": true, "quantity": "About 840", "codes": "", "remedy": "Consumers should immediately secure the recalled serum bottles out of sight and reach of children, and contact Feel The Beard for instructions on destroying the recalled bottles and receiving a replacement. Consumers will be asked to pour the contents of the bottle into the trash and take a photo of the bottle in the trash and email it to ziyad@feelthebeard.com. Replace", "retailers": ["Online at Amazon.com from April 2025 through September 2025 for about $10."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Feel-The-Beard-Recalls-Minoxidil-Beard-Growth-Serum-Bottles-Due-to-Risk-of-Serious-Injury-or-Death-from-Child-Poisoning-Violates-Mandatory-Standard-for-Child-Resistant-Packaging", "url": "https://recallledger.net/recalls/product-26158-feel-the-beard-recalls-minoxidil-beard-growth-serum-bottles-due-to-ris/"}, {"id": "cpsc-26157", "source": "CPSC", "category": "consumer-product", "recall_number": "26157", "title": "Plantimex Recalls Mamisan Lidocaine Ointment Containers Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging", "product": "Mamisan Pain Relieving Topical Ointment", "reason": "The ointment contains lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The ointment's packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.", "hazard_level": null, "company": "MiramarLab, of Doral, Florida", "company_location": "United States", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Walmart and Target stores nationwide and online at Target.com from April 2024 through October 2025 for about $10.", "states": [], "nationwide": true, "quantity": "About 50,330", "codes": "UPCs: 860006498115", "remedy": "Consumers should immediately secure the recalled ointment jars out of the sight and reach of children and contact Plantimex to receive a free replacement lid. Once the product is secured with the replacement lid, consumers can use the product, as directed. Repair", "retailers": ["Walmart and Target stores nationwide and online at Target.com from April 2024 through October 2025 for about $10."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Plantimex-Recalls-Mamisan-Lidocaine-Ointment-Containers-Due-to-Risk-of-Serious-Injury-or-Death-from-Child-Poisoning-Violates-Mandatory-Standard-for-Child-Resistant-Packaging", "url": "https://recallledger.net/recalls/product-26157-plantimex-recalls-mamisan-lidocaine-ointment-containers-due-to-risk-of/"}, {"id": "cpsc-26156", "source": "CPSC", "category": "consumer-product", "recall_number": "26156", "title": "17 Stories Furniture 18-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Imported by Shenzhen Jinhongzhen Technology Co", "product": "17 Stories Furniture 18-Drawer Dressers", "reason": "The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazard that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.", "hazard_level": null, "company": "Jiangsu Quanronghe Smart Home Co., Ltd., of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Wayfair.com from September 2023 through November 2025 for about $100.", "states": [], "nationwide": true, "quantity": "About 2,800", "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 17 Stories Furniture for instructions on how to dispose of the dressers to receive a full refund. Consumers must submit a photo to Drawer18Recall@outlook.com demonstrating disposal of the product. Refund", "retailers": ["Wayfair.com from September 2023 through November 2025 for about $100."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/17-Stories-Furniture-18-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violates-Mandatory-Standard-for-Clothing-Storage-Units-Imported-by-Shenzhen-Jinhongzhen-Technology-Co", "url": "https://recallledger.net/recalls/product-26156-17-stories-furniture-18-drawer-dressers-recalled-due-to-risk-of-seriou/"}, {"id": "cpsc-26155", "source": "CPSC", "category": "consumer-product", "recall_number": "26155", "title": "Currey & Company Recalls Electra Chandeliers Due to Impact Injury Hazard", "product": "Electra Chandelier and Electra Three Tier Chandelier light fixtures", "reason": "The component that connects the recalled chandelier light fixture to the ceiling mount is not threaded properly and the fixture can fall unexpectedly, posing a risk of injury from impact.", "hazard_level": null, "company": "Currey & Company, Inc., of Atlanta, Georgia", "company_location": "India", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Currey & Company showrooms, lighting stores nationwide, and online atwww.curreyandcompany.com and other e-commerce home retailers from May 2024 to September 2025 for between $3,000 and $10,000.", "states": [], "nationwide": true, "quantity": "About 260", "codes": "", "remedy": "Consumers should immediately contact Currey & Company to receive a free in-home repair kit to replace the connection component. Currey will pay the consumer's professional installation costs directly or reimburse consumers for the full cost of the professional installation of the repair. Repair", "retailers": ["Currey & Company showrooms, lighting stores nationwide, and online atwww.curreyandcompany.com and other e-commerce home retailers from May 2024 to September 2025 for between $3,000 and $10,000."], "injuries": "The firm has received two reports of the chandelier light fixtures falling from the ceiling, with one incident involving property damage. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Currey-Company-Recalls-Electra-Chandeliers-Due-to-Impact-Injury-Hazard", "url": "https://recallledger.net/recalls/product-26155-currey-company-recalls-electra-chandeliers-due-to-impact-injury-haza/"}, {"id": "cpsc-26154", "source": "CPSC", "category": "consumer-product", "recall_number": "26154", "title": "TopHomer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by TopHomerUS", "product": "TopHomer Pool Drain Covers", "reason": "The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.", "hazard_level": null, "company": "Guangzhoushuoshenghaoyikejiyouxiangongsi, dba TopHomerUS, of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Amazon.com from August 2024 through October 2025 for between $15 and $26.", "states": [], "nationwide": true, "quantity": "About 1,040", "codes": "", "remedy": "Pool owners, pool operators and consumers should immediately stop using pools with the recalled pool drain covers. To receive a refund, consumers should remove the drain cover from the pool, take a photo of the removed cover, and send it to the recalling firm by email at Tophomer.recall@outlook.com. Ensure all pools and spas have VGBA-compliant drain covers and teach children to stay away from drains. Refund", "retailers": ["Amazon.com from August 2024 through October 2025 for between $15 and $26."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/TopHomer-Pool-Drain-Covers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Entrapment-and-Drowning-Hazards-Violation-of-the-Virginia-Graeme-Baker-Pool-and-Spa-Safety-Act-Sold-on-Amazon-by-TopHomerUS", "url": "https://recallledger.net/recalls/product-26154-tophomer-pool-drain-covers-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26153", "source": "CPSC", "category": "consumer-product", "recall_number": "26153", "title": "Furnulem 8-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violate Mandatory Standard for Clothing Storage Units; Sold on Amazon by Furnulem", "product": "Furnulem 8-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 serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.", "hazard_level": null, "company": "Shanghai Taiye Furniture Co., Ltd., dba Furnulem, of China", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2023 through November 2025 for about $80.", "states": [], "nationwide": true, "quantity": "About 16,800", "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. Contact Furnulem for instructions on how to dispose of the dressers to receive a full refund. Consumers must submit a photo to support@furnulem.com demonstrating disposal of the product. Refund", "retailers": ["Online at Amazon.com from September 2023 through November 2025 for about $80."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Furnulem-8-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Violate-Mandator-Standard-for-Clothing-Storage-Units-Sold-on-Amazon-by-Furnulem", "url": "https://recallledger.net/recalls/product-26153-furnulem-8-drawer-dressers-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26152", "source": "CPSC", "category": "consumer-product", "recall_number": "26152", "title": "Pedego Electric Bikes Recalls Fat Tire Trikes Due to Fall and Laceration Hazards", "product": "Fat Tire Trikes", "reason": "The trike frame can develop a hairline fracture near a weld, which can cause the tubes to separate, posing fall and laceration hazards.", "hazard_level": null, "company": "Pedego, LLC, of Fountain View, California", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Pedego stores nationwide and online at PedegoElectricBikes.com from March 2024 through March 2025 for between $3,500 and $4,000.", "states": [], "nationwide": true, "quantity": "About 400", "codes": "", "remedy": "Consumers should immediately stop using the recalled Fat Tire Trikes and contact Pedego to schedule a repair involving the replacement of a section of the frame, which will be installed by a Pedego dealer of their choice at no charge to the consumer. Consumers should fill out a registration form at https://pedegoelectricbikes.com/pages/product-recalls. Repair", "retailers": ["Pedego stores nationwide and online at PedegoElectricBikes.com from March 2024 through March 2025 for between $3,500 and $4,000."], "injuries": "Pedego has received 16 reports of the trike frame breaking, including one report of a laceration to the leg.", "source_url": "https://www.cpsc.gov/Recalls/2026/Pedego-Electric-Bikes-Recalls-Fat-Tire-Trikes-Due-to-Fall-and-Laceration-Hazards", "url": "https://recallledger.net/recalls/product-26152-pedego-electric-bikes-recalls-fat-tire-trikes-due-to-fall-and-lacerati/"}, {"id": "cpsc-26151", "source": "CPSC", "category": "consumer-product", "recall_number": "26151", "title": "Pacific Cycle Recalls Schwinn Ovation Bicycle Child Carriers Due to Fall Hazard", "product": "Schwinn Ovation Bicycle Child Carriers", "reason": "The buckles securing the restraints around the child can release during use, posing a fall hazard.", "hazard_level": null, "company": "Pacific Cycle Inc., of Madison, Wisconsin", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Amazon.com and schwinnbikes.com from May 2025 through September 2025 for between $190 and $230.", "states": [], "nationwide": true, "quantity": "About 650", "codes": "", "remedy": "Consumers should immediately stop using the recalled carriers and contact Pacific Cycle for a full refund. Refund", "retailers": ["Amazon.com and schwinnbikes.com from May 2025 through September 2025 for between $190 and $230."], "injuries": "Pacific Cycle is aware of one incident where the buckles released. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Pacific-Cycle-Recalls-Schwinn-Ovation-Bicycle-Child-Carriers-Due-to-Fall-Hazard", "url": "https://recallledger.net/recalls/product-26151-pacific-cycle-recalls-schwinn-ovation-bicycle-child-carriers-due-to-fa/"}, {"id": "cpsc-26150", "source": "CPSC", "category": "consumer-product", "recall_number": "26150", "title": "Amp Fit Recalls AMP Smart Fitness Machines Due to Laceration and Serious Injury Hazard", "product": "AMP MP2 Smart Fitness Machine", "reason": "The arm on the MP2 model of the fitness machine does not lock properly, which can allow the arm to swing unexpectedly, posing a risk of laceration or serious injury.", "hazard_level": null, "company": "Amp Fit, Inc., of Middletown, Delaware", "company_location": "China", "date": "2025-12-18", "report_date": "2025-12-18", "status": "Announced", "distribution": "Sold in the United States at Online at Ampfit.com from January 2025 through August 2025 for about $1,800.", "states": [], "nationwide": true, "quantity": "About 1,900", "codes": "", "remedy": "Consumers should immediately stop using the recalled fitness machine and contact Amp Fit to schedule a free inspection and repair that will be conducted at the consumers' residence by an authorized technician. The repair involves the replacement of a part within the shoulder cap of the locking mechanism that helps to ensure the locking mechanism is fully engaged. Repair", "retailers": ["Online at Ampfit.com from January 2025 through August 2025 for about $1,800."], "injuries": "The firm has received 10 reports of the arm on the fitness machine not locking properly, resulting in lacerations to the head and bruising to the shoulder and other body.", "source_url": "https://www.cpsc.gov/Recalls/2026/Amp-Fit-Recalls-AMP-Smart-Fitness-Machines-Due-to-Laceration-and-Serious-Injury-Hazard", "url": "https://recallledger.net/recalls/product-26150-amp-fit-recalls-amp-smart-fitness-machines-due-to-laceration-and-serio/"}, {"id": "cpsc-26148", "source": "CPSC", "category": "consumer-product", "recall_number": "26148", "title": "Luyuan Recalls Youth ATVs Due to Risk of Serious Injury or Death from Crash Hazard; Violate Mandatory Standard for All-Terrain Vehicles", "product": "X-Pro Eagle 40cc Youth ATVs and FRP Sahara 40cc Youth ATVs", "reason": "The recalled youth ATVs violate the mandatory ATV safety standard. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. Additionally, the handlebars pose a laceration hazard, if the child rider's body or head impacts the handlebars at high speed. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death.", "hazard_level": null, "company": "Yongkang Luyuan Industrial & Trading Co., Ltd., of China", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at X-Pro Eagle 40cc Youth ATVs were sold online at Walmart.com, Powersportsmax.com, and Xprousa.com from June 2025 through September 2025 for between $480 and $500. FRP Sahara 40cc Youth ATVs were sold online at Amazon.com, Temu.com, and Frpmoto.com from April 2025 through September 2025 for between $460 and $480.", "states": [], "nationwide": true, "quantity": "About 2,290", "codes": "", "remedy": "Consumers should immediately stop using the X-Pro Eagle 40cc Youth ATVs and FRP Sahara 40cc Youth ATVs and contact Luyuan for a free repair from an authorized repair shop. Repair", "retailers": ["X-Pro Eagle 40cc Youth ATVs were sold online at Walmart.com, Powersportsmax.com, and Xprousa.com from June 2025 through September 2025 for between $480 and $500. FRP Sahara 40cc Youth ATVs were sold online at Amazon.com, Temu.com, and Frpmoto.com from April 2025 through September 2025 for between $460 and $480."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Luyuan-Recalls-Youth-ATVs-Due-to-Risk-of-Serious-Injury-or-Death-from-Crash-Hazard-Violate-Mandatory-Standard-for-All-Terrain-Vehicles", "url": "https://recallledger.net/recalls/product-26148-luyuan-recalls-youth-atvs-due-to-risk-of-serious-injury-or-death-from/"}, {"id": "cpsc-26147", "source": "CPSC", "category": "consumer-product", "recall_number": "26147", "title": "Sanven Technology Recalls Vevor Ice Crushers Due to Fire Hazard", "product": "Vevor Ice Crushers", "reason": "The ice crusher can experience a thermal event and ignite, posing a fire hazard.", "hazard_level": null, "company": "Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Online at Vevor.com, Amazon.com, Walmart.com, Wayfair.com, HomeDepot.com and Lowes.com from July 2021 through July 2025 for between $40 and $86.", "states": [], "nationwide": true, "quantity": "About 11,650 (In addition, about 1,060 were sold in Canada)", "codes": "", "remedy": "Consumers should immediately stop using the recalled ice crusher and contact Sanven for a full refund. Consumers should email a photograph of the ice crusher with the unplugged power cord cut in half to recalling@vevor.com. Refund", "retailers": ["Online at Vevor.com, Amazon.com, Walmart.com, Wayfair.com, HomeDepot.com and Lowes.com from July 2021 through July 2025 for between $40 and $86."], "injuries": "Sanven has received two reports of thermal events, including one fire.", "source_url": "https://www.cpsc.gov/Recalls/2026/Sanven-Technology-Recalls-Vevor-Ice-Crushers-Due-to-Fire-Hazard", "url": "https://recallledger.net/recalls/product-26147-sanven-technology-recalls-vevor-ice-crushers-due-to-fire-hazard/"}, {"id": "cpsc-26146", "source": "CPSC", "category": "consumer-product", "recall_number": "26146", "title": "YCXXKJ Baby Bath Seats Recalled Due to Risk of Serious Injury or Death to Children from Drowning; Violate Mandatory Standard for Infant Bath Seats; Sold on Amazon by BenTalk", "product": "YCXXKJ Baby Bath Seats", "reason": "The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or death due to drowning.", "hazard_level": null, "company": "Zhengzhou Bentuo Trading Co., Ltd., dba BenTalk, of China", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from May 2024 through October 2025 for between $34 and $40.", "states": [], "nationwide": true, "quantity": "About 8,960", "codes": "", "remedy": "Consumers should immediately stop using the recalled bath seats and contact BenTalk to request a full refund. Consumers should send two photos of the recalled bath seats to BenTalk at bentalkhere@outlook.com. The first photo should have \"Recalled\" written on the front of the bath seat in permanent marker. The second photo should show the bath seat disassembled with the components removed. Refund", "retailers": ["Online at Amazon.com from May 2024 through October 2025 for between $34 and $40."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/YCXXKJ-Baby-Bath-Seats-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-to-Children-from-Drowning-Violate-Mandatory-Standard-for-Infant-Bath-Seats-Sold-on-Amazon-by-BenTalk", "url": "https://recallledger.net/recalls/product-26146-ycxxkj-baby-bath-seats-recalled-due-to-risk-of-serious-injury-or-death/"}, {"id": "cpsc-26142", "source": "CPSC", "category": "consumer-product", "recall_number": "26142", "title": "Sanven Technology Recalls VEVOR Steamers Due to Risk of Serious Injury from Burn Hazard", "product": "VEVOR Garment Steamers", "reason": "The steamers can leak or spit hot water, posing a risk of serious burn injury to users and bystanders. The water tank cap can also leak or detach during use, exposing users to hot water.", "hazard_level": null, "company": "Sanven Technology Ltd., dba VEVOR, of Rancho Cucamonga, California", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Online at Vevor.com, Amazon.com and HomeDepot.com from December 2023 to September 2025 for between about $10 and $33.", "states": [], "nationwide": true, "quantity": "About 2,840", "codes": "", "remedy": "Consumers should immediately stop using the recalled steamers and contact Sanven Technology for a full refund. Consumers will be asked to provide their contact information and send a photo of the steamer with its unplugged cut power cord to receive a full refund. Refund", "retailers": ["Online at Vevor.com, Amazon.com and HomeDepot.com from December 2023 to September 2025 for between about $10 and $33."], "injuries": "The Firm has received six reports of hot water spitting, pouring out, leaking or dripping from the steamers, and 12 reports of issues with the water tank cap detaching, leaking, not staying closed, fitting loosely, or melting. The reported cap issues resulted in two burn injuries, including one consumer who received a permanent scar and a second-degree burn from the hot water, after the steamer's cap suddenly detached and one consumer who received a minor burn on their hand and fingers from leaked water. Additionally, there is one report of a minor steam burn through the provided glove.", "source_url": "https://www.cpsc.gov/Recalls/2026/Sanven-Technology-Recalls-VEVOR-Steamers-Due-to-Risk-of-Serious-Injury-from-Burn-Hazard", "url": "https://recallledger.net/recalls/product-26142-sanven-technology-recalls-vevor-steamers-due-to-risk-of-serious-injury/"}, {"id": "cpsc-26141", "source": "CPSC", "category": "consumer-product", "recall_number": "26141", "title": "Uuoeebb Infant 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 BaoD", "product": "Uuoeebb Infant 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": "Hunan Suihuo E-commerce Co., Ltd., dba BaoD, of China", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from December 2024 through September 2025 for between $60 and $90.", "states": [], "nationwide": true, "quantity": "About 2,650", "codes": "", "remedy": "Consumers should stop using the recalled infant walkers immediately and contact BaoD for a full refund. Consumers should disassemble the walker, remove the fabric seat, write \"Recalled\" on the top of the tray in permanent marker, and email a photo of the recalled infant walker to BaoD at Uuoeebbrecalls@outlook.com. Consumers should dispose of the recalled infant walkers in accordance with state and local waste disposal procedures. Refund", "retailers": ["Online at Amazon.com from December 2024 through September 2025 for between $60 and $90."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Uuoeebb-Infant-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-BaoD", "url": "https://recallledger.net/recalls/product-26141-uuoeebb-infant-walkers-recalled-due-to-risk-of-serious-injury-or-death/"}, {"id": "cpsc-26140", "source": "CPSC", "category": "consumer-product", "recall_number": "26140", "title": "SKCAIHT Children's Costumes Recalled Due to Risk of Injury from Phthalate Exposure; Violates Federal Phthalates Ban; Sold on Amazon by SKCAIHT Direct", "product": "SKCAIHT Children's Little Mermaid Costumes", "reason": "The children's costumes contain a prohibited phthalate, which violates the federal phthalates ban. Phthalates are toxic if ingested by young children and can cause adverse health effects.", "hazard_level": null, "company": "Yiwu Qiangyao E-Commerce Co., Ltd., dba SKCAIHT Direct, of China", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from March 2022 through July 2025 for about $30.", "states": [], "nationwide": true, "quantity": "About 1,300", "codes": "", "remedy": "Consumers should immediately stop using the recalled costumes and take them away from children. Contact SKCAIHT Direct for a full refund. Consumers should cut the dress and submit a photo of the destroyed costume to pafiney@outlook.com. Refund", "retailers": ["Online at Amazon.com from March 2022 through July 2025 for about $30."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/SKCAIHT-Childrens-Costumes-Recalled-Due-to-Risk-of-Injury-from-Phthalate-Exposure-Violates-Federal-Phthalates-Ban-Sold-on-Amazon-by-SKCAIHT-Direct", "url": "https://recallledger.net/recalls/product-26140-skcaiht-children-s-costumes-recalled-due-to-risk-of-injury-from-phthal/"}, {"id": "cpsc-26139", "source": "CPSC", "category": "consumer-product", "recall_number": "26139", "title": "Primark Recalls Little Bear 2-Pack Soother Clips Due to Choking and Laceration Hazards", "product": "Little Bear 2-pack Soother Clip", "reason": "The wooden button on the soother clips can come off, exposing a sharp screw, which can pose choking and laceration hazards.", "hazard_level": null, "company": "Primark US Corp., of Boston, Massachusetts", "company_location": "China", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Primark stores located in the northeast and in Florida, Maryland and Illinois from June 2025 through August 2025 for about $5.", "states": [], "nationwide": true, "quantity": "About 1,330", "codes": "", "remedy": "Consumers should immediately stop using the recalled soother clips and return them to a Primark store for a full refund in the original form of payment. Refund", "retailers": ["Primark stores located in the northeast and in Florida, Maryland and Illinois from June 2025 through August 2025 for about $5."], "injuries": "The firm has received five reports of the wooden buttons on the soother clip detaching, including one report where the screw was found inside an infant's mouth and a second report of cuts to a child's arm.", "source_url": "https://www.cpsc.gov/Recalls/2026/Primark-Recalls-Little-Bear-2-Pack-Soother-Clips-Due-to-Choking-and-Laceration-Hazards", "url": "https://recallledger.net/recalls/product-26139-primark-recalls-little-bear-2-pack-soother-clips-due-to-choking-and-la/"}, {"id": "cpsc-26138", "source": "CPSC", "category": "consumer-product", "recall_number": "26138", "title": "TREK Recalls Electric Bicycles Due to Fall or Crash Hazard", "product": "Model Year 2026 Trek-branded Domane+ ALR 5, Domane+ ALR 6 AXS, Checkpoint+ SL 6 and Checkpoint+ SL 7 Electric Bicycles", "reason": "The bolts on the chainring can come loose, causing the chainring to separate from the bike, resulting in a fall or crash hazard to the user.", "hazard_level": null, "company": "Trek Bicycle Corporation, of Waterloo, Wisconsin", "company_location": "Cambodia", "date": "2025-12-11", "report_date": "2025-12-11", "status": "Announced", "distribution": "Sold in the United States at Independent bicycle retailers and Trek authorized retailers nationwide and online from July 2025 through September 2025 for between $5,000 and $8,000.", "states": [], "nationwide": true, "quantity": "About 700", "codes": "", "remedy": "Consumers should immediately stop using the recalled bicycles and contact an authorized Trek dealer to schedule a free repair at the dealer location. The dealer will tighten the chainring bolts to the correct specification. Trek will provide consumers who participate in the recall with a $20 in-store credit toward Trek, Electra, or Bontrager merchandise. The credit is valid through December 31, 2026. Repair", "retailers": ["Independent bicycle retailers and Trek authorized retailers nationwide and online from July 2025 through September 2025 for between $5,000 and $8,000."], "injuries": "The firm has received three reports of the bicycle chainring coming loose on the recalled bikes. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/TREK-Recalls-Electric-Bicycles-Due-to-Fall-or-Crash-Hazard", "url": "https://recallledger.net/recalls/product-26138-trek-recalls-electric-bicycles-due-to-fall-or-crash-hazard/"}, {"id": "cpsc-26135", "source": "CPSC", "category": "consumer-product", "recall_number": "26135", "title": "INIU Recalls Power Banks Due to Fire and Burn Hazards; Sold on Amazon", "product": "INIU BI-B41 Power Banks", "reason": "The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.", "hazard_level": null, "company": "Shenzhen Topstar Industry Co., Ltd., of China", "company_location": "China", "date": "2025-12-05", "report_date": "2025-12-05", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from August 2021 and April 2022 for about $18.", "states": [], "nationwide": true, "quantity": "About 210,000", "codes": "", "remedy": "Consumers should immediately stop using the recalled planers and contact Grizzly Industrial for a free repair kit and installation instructions. The repair kit consists of an upgraded chip breaker adjustment rod, spacer, set screws, lock washers, and lock nuts. Refund", "retailers": ["Online at Amazon.com from August 2021 and April 2022 for about $18."], "injuries": "INIU has received 15 reports of power banks overheating, including 11 reports of fires that resulted in three minor burn injuries and property damage totaling over $380,000.", "source_url": "https://www.cpsc.gov/Recalls/2026/INIU-Recalls-Power-Banks-Due-to-Fire-and-Burn-Hazards-Sold-on-Amazon", "url": "https://recallledger.net/recalls/product-26135-iniu-recalls-power-banks-due-to-fire-and-burn-hazards-sold-on-amazon/"}, {"id": "cpsc-26134", "source": "CPSC", "category": "consumer-product", "recall_number": "26134", "title": "Grizzly Industrial Recalls Heavy-Duty Planers Due to Impact and Laceration Hazards", "product": "G0815 15\" 3HP Heavy-Duty Planers", "reason": "The chip breaker can contact the cutterhead blades during use, which can cause debris to be ejected from the planer, posing impact and laceration hazards to the user and bystander.", "hazard_level": null, "company": "Grizzly Industrial Inc., of Bellingham, Washington", "company_location": "Taiwan", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Bibb Tool & Cutter, Hamilton Tool and Supply, PMC Tool Company and Stoll Brothers Lumber stores and other hardware stores nationwide and online at Grizzly.com, HomeDepot.com, Tractor Supply.com and MaxTool.com and other websites from June 2016 through September 2025 for between $900 and $2,400.", "states": [], "nationwide": true, "quantity": "About 2,300 (In addition, 12 were sold in Canada)", "codes": "", "remedy": "Consumers should immediately stop using the recalled planers and contact Grizzly Industrial for a free repair kit and installation instructions. The repair kit consists of an upgraded chip breaker adjustment rod, spacer, set screws, lock washers, and lock nuts. Repair", "retailers": ["Bibb Tool & Cutter, Hamilton Tool and Supply, PMC Tool Company and Stoll Brothers Lumber stores and other hardware stores nationwide and online at Grizzly.com, HomeDepot.com, Tractor Supply.com and MaxTool.com and other websites from June 2016 through September 2025 for between $900 and $2,400."], "injuries": "Grizzly Industrial has received seven reports of the rotating cutters of the planers breaking. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/Grizzly-Industrial-Recalls-Heavy-Duty-Planers-Due-to-Impact-and-Laceration-Hazards", "url": "https://recallledger.net/recalls/product-26134-grizzly-industrial-recalls-heavy-duty-planers-due-to-impact-and-lacera/"}, {"id": "cpsc-26133", "source": "CPSC", "category": "consumer-product", "recall_number": "26133", "title": "Cubimana Building Toy Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Shein by Vatos Toys", "product": "Cubimana Treehouse Building Toy Sets", "reason": "The building toy sets violate the mandatory safety standard because the battery compartment within the LED light piece contains button cell batteries that can be easily accessed by children. 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 Excellence Qichuang Technology, dba Vatos Toys, of China", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Online at Shein.com from July 2025 through October 2025 for about $20.", "states": [], "nationwide": true, "quantity": "About 40", "codes": "", "remedy": "Consumers should immediately stop using the recalled toy sets, take them away from children, and remove and properly dispose of the batteries. Contact Vatos Toys for a full refund. Consumers should throw the piece with the LED light away and send a photo of the product in the trash to shein.us@vatostoys.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 Shein.com from July 2025 through October 2025 for about $20."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Cubimana-Building-Toy-Sets-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violates-Mandatory-Standard-for-Toys-Sold-on-Shein-by-Vatos-Toys", "url": "https://recallledger.net/recalls/product-26133-cubimana-building-toy-sets-recalled-due-to-risk-of-serious-injury-or-d/"}, {"id": "cpsc-26132", "source": "CPSC", "category": "consumer-product", "recall_number": "26132", "title": "Little Pea Shop Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold by Little Pea Shop", "product": "Little Pea Shop Crib Bumpers", "reason": "The recalled crib bumpers violate the federal crib bumper ban because they can obstruct an infant's breathing, posing a risk of serious injury or death, due to suffocation. This creates an unsafe sleeping environment for infants. Padded crib bumpers are banned by the Safe Sleep for Babies Act.", "hazard_level": null, "company": "Little Pea Shop, of France", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2025 through October 2025 for between $8 and $30.", "states": [], "nationwide": true, "quantity": "About 300", "codes": "", "remedy": "Consumers should immediately stop using the recalled crib bumpers and contact Little Pea Shop for a full refund. Consumers should remove the crib bumpers, cut the padding and email a photo of the destroyed bumpers to support@littlepeashop.com. Refund", "retailers": ["Online at Amazon.com from September 2025 through October 2025 for between $8 and $30."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Little-Pea-Shop-Crib-Bumpers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Suffocation-Violates-Federal-Crib-Bumper-Ban-Sold-by-Little-Pea-Shop", "url": "https://recallledger.net/recalls/product-26132-little-pea-shop-crib-bumpers-recalled-due-to-risk-of-serious-injury-or/"}, {"id": "cpsc-26131", "source": "CPSC", "category": "consumer-product", "recall_number": "26131", "title": "KTEBO Writing Tablet Toys Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by KTEBO", "product": "KTEBO Writing Tablet Toy", "reason": "The recalled toys violate the mandatory standard for toys because the screw used to secure the battery compartment that contains a button cell battery does not remain attached as required. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.", "hazard_level": null, "company": "Banghe Guangzhou International Trade Co., Ltd., dba KTEBO, of China", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2025 through October 2025 for between $8 and $30.", "states": [], "nationwide": true, "quantity": "About 10,380", "codes": "", "remedy": "Consumers should immediately stop using the recalled writing tablet toys and contact KTEBO for a free replacement set of tablet toys. Consumers should write \"RECALLED\" on the back of both tablet toys that came in the set, take a photo of the marked tablet toys, and submit the photos to writing-tablet-recall@ktebo.com with \"Recall Proof\" and their name in the subject line. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures. Replace", "retailers": ["Online at Amazon.com from September 2025 through October 2025 for between $8 and $30."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/KTEBO-Writing-Tablet-Toys-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Battery-Ingestion-Violates-Mandatory-Standard-for-Toys-Sold-on-Amazon-by-KTEBO", "url": "https://recallledger.net/recalls/product-26131-ktebo-writing-tablet-toys-recalled-due-to-risk-of-serious-injury-or-de/"}, {"id": "cpsc-26129", "source": "CPSC", "category": "consumer-product", "recall_number": "26129", "title": "HydroJug Recalls 14-Ounce Children's Sport Tumblers Due to Choking Hazard", "product": "14-ounce Children's Sport Tumbler", "reason": "The rivets on the handle can come loose, causing the handle to detach, posing a choking hazard for children.", "hazard_level": null, "company": "HydroJug, Inc., of Ogden, Utah", "company_location": "United States", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Academy Sports, Scheels, Combined Sales Company, Gordons Ace Hardware, Bucks Ace, Kents Grocery, Basin Sports and online at Hydrojug.com, Amazon.com, Well.ca and iHerb.com from May 2025 through June 2025 for about $25.", "states": [], "nationwide": true, "quantity": "About 17,000", "codes": "", "remedy": "Consumers should immediately stop using the recalled 14-ounce sport tumbler and contact HydroJug for a free replacement lid. Consumers should email HydroJug at service@thehydrojug.com and provide order details (if available), shipping address and photos of the bottom of the tumbler showing the serial number or that there is no serial number. Consumers will be asked to include photos of the recalled tumbler lid permanently marked with the word \"Recalled\" and to dispose of the recalled tumbler lid. HydroJug will confirm eligibility and send a replacement lid. Replace", "retailers": ["Academy Sports, Scheels, Combined Sales Company, Gordons Ace Hardware, Bucks Ace, Kents Grocery, Basin Sports and online at Hydrojug.com, Amazon.com, Well.ca and iHerb.com from May 2025 through June 2025 for about $25."], "injuries": "The firm has received 656 reports of the rivets on the handle coming loose. No injuries have been reported.", "source_url": "https://www.cpsc.gov/Recalls/2026/HydroJug-Recalls-14-Ounce-Childrens-Sport-Tumblers-Due-to-Choking-Hazard", "url": "https://recallledger.net/recalls/product-26129-hydrojug-recalls-14-ounce-children-s-sport-tumblers-due-to-choking-haz/"}, {"id": "cpsc-26128", "source": "CPSC", "category": "consumer-product", "recall_number": "26128", "title": "CreateOn Recalls Pip-Cubes Due to Risk of Serious Injury or Death from Magnet Ingestion Hazard", "product": "CreateOn Crayola-branded pip-Cubes", "reason": "The recalled magnetic building cubes contain magnets that can become loose if the seams separate, 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": "CreateOn, LLC, of Wheeling, Illinois", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at The 24-piece sets were sold at Michael's Stores nationwide and online at Michaels.com for about $20. The 27-piece sets were sold online at Amazon.com for about $35. All sets were sold from May 2025 to July 2025.", "states": [], "nationwide": true, "quantity": "About 9,400", "codes": "", "remedy": "Consumers should immediately stop using the recalled magnetic building cubes, take them away from children and contact CreateOn to receive a replacement set of pip-cubes. Consumers will receive a pre-paid label to return the recalled magnetic cubes in order to receive the replacement. Replace", "retailers": ["The 24-piece sets were sold at Michael's Stores nationwide and online at Michaels.com for about $20. The 27-piece sets were sold online at Amazon.com for about $35. All sets were sold from May 2025 to July 2025."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/CreateOn-Recalls-Pip-Cubes-Due-to-Risk-of-Serious-Injury-or-Death-from-Magnet-Ingestion-Hazard", "url": "https://recallledger.net/recalls/product-26128-createon-recalls-pip-cubes-due-to-risk-of-serious-injury-or-death-from/"}, {"id": "cpsc-26127", "source": "CPSC", "category": "consumer-product", "recall_number": "26127", "title": "Casaottima 13-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by Casaottima", "product": "Casaottima 13-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 a risk of serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.", "hazard_level": null, "company": "Changzhou Municipal Sea Metal Products Co. Ltd., of China", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Online at Amazon.com from September 2024 through October 2025 for about $90.", "states": [], "nationwide": true, "quantity": "About 4,120", "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. Contact Casaottima for instructions on how to dispose of the dressers to receive a full refund. Consumers must submit a photo to support@casaottima.store showing disposal of the product. Refund", "retailers": ["Online at Amazon.com from September 2024 through October 2025 for about $90."], "injuries": "None reported", "source_url": "https://www.cpsc.gov/Recalls/2026/Casaottima-13-Drawer-Dressers-Recalled-Due-to-Risk-of-Serious-Injury-or-Death-from-Tip-Over-and-Entrapment-Hazards-Violates-Mandatory-Standard-for-Clothing-Storage-Units-Sold-on-Amazon-by-Casaottima", "url": "https://recallledger.net/recalls/product-26127-casaottima-13-drawer-dressers-recalled-due-to-risk-of-serious-injury-o/"}, {"id": "cpsc-26126", "source": "CPSC", "category": "consumer-product", "recall_number": "26126", "title": "Ningbo Tianqi Electronic Recalls FUFU&GAGA Murphy Wall Beds Due to Impact and Laceration Hazards", "product": "FUFU&GAGA White Wood Frame Queen Size Murphy Wall Beds", "reason": "During assembly or disassembly, the 215-pound frame of the wall bed can fall onto consumers, posing deadly impact, crush, and laceration hazards.", "hazard_level": null, "company": "Jiangsu Liangjiang Intelligent Furniture Co., Ltd, of China", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Online at HomeDepot.com and Lowes.com from January 2025 through April 2025 for about $550.", "states": [], "nationwide": true, "quantity": "About 250", "codes": "", "remedy": "Consumers should immediately stop using the recalled wall beds and contact Ningbo Tianqi Electronic for a full refund. To obtain a refund, consumers will be provided with a disassembly kit that contains tools, brackets and screws with instructions on how to disassemble and discard the wall beds. Refund", "retailers": ["Online at HomeDepot.com and Lowes.com from January 2025 through April 2025 for about $550."], "injuries": "The firm has received two reports of the wall beds falling during assembly when the wall beds were not anchored to the wall, resulting in two injured consumers. One consumer sustained a laceration, a bruise, and a fractured growth plate in her finger, and another consumer sustained a laceration to his face that required eight stitches.", "source_url": "https://www.cpsc.gov/Recalls/2026/Ningbo-Tianqi-Electronic-Recalls-FUFU&GAGA-Murphy-Wall-Beds-Due-to-Impact-and-Laceration-Hazards", "url": "https://recallledger.net/recalls/product-26126-ningbo-tianqi-electronic-recalls-fufu-gaga-murphy-wall-beds-due-to-imp/"}, {"id": "cpsc-26124", "source": "CPSC", "category": "consumer-product", "recall_number": "26124", "title": "Primark US Recalls Primark Water Balloon Pumps Due to Injury Hazard", "product": "Primark Water Balloon Pump", "reason": "The water balloon pump can generate excessive pressure during use, causing the product to rupture, posing a risk of physical injury to the user or bystanders.", "hazard_level": null, "company": "Primark US Corp., of Boston, Massachusetts", "company_location": "China", "date": "2025-12-04", "report_date": "2025-12-04", "status": "Announced", "distribution": "Sold in the United States at Primark stores in the northeast and in Florida, Maryland and Illinois from March 2023 through July 2023 for about $6.", "states": [], "nationwide": true, "quantity": "About 3,170", "codes": "", "remedy": "Consumers should immediately stop using the recalled water balloon pumps and return them to a Primark store for a full refund in the form of the original payment. Refund", "retailers": ["Primark stores in the northeast and in Florida, Maryland and Illinois from March 2023 through July 2023 for about $6."], "injuries": "The firm has received two reports in the United States (and nine reports internationally) of the water balloon pumps rupturing, resulting in two reports of cuts on users' hands and fingers in the United States (and nine reports of cuts internationally).", "source_url": "https://www.cpsc.gov/Recalls/2026/Primark-US-Recalls-Primark-Water-Balloon-Pumps-Due-to-Injury-Hazard", "url": "https://recallledger.net/recalls/product-26124-primark-us-recalls-primark-water-balloon-pumps-due-to-injury-hazard/"}]}