Recalls in Missouri (page 25)
3996 recalls.
- ZWILLING J. A. Henckels Aktiengesellschaft Recalls Electric Water Kettles Due to Risk of Serious Injury Due to Burn Hazard
Consumer productReported May 15, 2026 · The kettle's handle can loosen and separate from the kettle, causing hot contents to spill, posing a risk of serious injury due to a burn hazard. - Petzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported May 15, 2026 · The recalled harness' D-ring can release, allowing the attachment point to open, posing a risk of serious injury or death from a fall hazard. - Petzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported May 15, 2026 · The recalled harnesses are missing rivets in the FAST LT PIN-LOCK buckles, causing the buckles to open, posing a risk of serious injury or death from a fall... - Amazon Recalls Amazon Basics 55 Lbs. Adjustable Dumbbells Due to Impact Hazard
Consumer productReported May 15, 2026 · The weight plates can fail to engage completely during weight adjustment and dislodge from the dumbbell handle when used, posing an impact hazard. - World Bright International Limited Recalls Agio Menlo Woven Patio Swings Due to Risk of Serious Injury or Death from Fall Hazard; Sold at Costco
Consumer productReported May 15, 2026 · The swing seat can detach from the frame while in use, posing a risk of serious injury or death from a fall hazard. - Lithium Coin Batteries Recalled Due?to Risk of Serious Injury or Death from Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Coin Batteries; Imported and Sold on Amazon by LiCB
Consumer productReported May 15, 2026 · The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button cell or coin... - Missry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys
Consumer productReported May 15, 2026 · The Misco Sports Badminton Toy Sets violate the mandatory safety standard for children's toys because the shuttlecocks contain button cell batteries that can... - BRP Recalls Can-Am All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury and Death from Crash Hazard
Consumer productReported May 15, 2026 · The ATV's speed limiter control can malfunction, causing unexpected speed and acceleration, posing a serious risk of injury or death from crash hazard. - Tiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Sold on Amazon by ZW Creations
Consumer productReported May 15, 2026 · The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can... - Superbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop
Consumer productReported May 15, 2026 · The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and... - Minka Lighting Group Recalls Bardon Series Pendant Light Fixtures Due to Risk of Serious Injury or Death from an Impact Hazard
Consumer productReported May 15, 2026 · The recalled light fixture's frame can detach from the pendant downrod during installation, posing a risk of serious injury or death from an impact hazard. - Good & Gather Fresh from Our Deli. Sesame Teriyaki Chicken with Rice. Net Wt 18.0 oz recall (Target Corporation)
FoodClass IIReported May 13, 2026 · Undeclared allergens (sesame and soy) - french broad CHOCOLATE bette's bake sale recall (French Broad Chocolate Factory)
FoodClass IReported May 13, 2026 · Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor... - SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI recall (Falcon Trading Co., Inc.)
FoodClass IIIReported May 13, 2026 · Potential contamination with pesticides, haloxyfop and thiamethoxam - SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI recall (Falcon Trading Co., Inc.)
FoodClass IIIReported May 13, 2026 · Potential contamination with pesticides, haloxyfop and thiamethoxam - SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI recall (Falcon Trading Co., Inc.)
FoodClass IIIReported May 13, 2026 · Potential contamination with pesticides, haloxyfop and thiamethoxam - ERBEFLO 2 recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported May 13, 2026 · Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. - Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard PERC TRAY kit. Model Numbers: SLPC34-01 recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard NEURO IR PERIPHERAL recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard HEART CATH recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard CATH LAB kit. Model Number: SACL75-01. recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard CATH LAB kit. Model Number: SACL75AM. recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04 recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05 recall (AVID Medical, Inc.)
Medical deviceClass IReported May 13, 2026 · Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe... - VOCSN V+Pro package recall (Ventec Life Systems, Inc.)
Medical deviceClass IReported May 13, 2026 · Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions... - Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 recall (Intuitive Surgical, Inc.)
Medical deviceClass IReported May 13, 2026 · Reloads for curved-tipped stapler may potentially produce an incomplete staple line. - Woodstock Organic Shelled Edamame 10 oz. and 48 oz. recall (Green Organic Vegetables)
FoodClass IIReported May 13, 2026 · Foreign object: metal pieces - Lactated Ringer's Injection USP recall (B BRAUN MEDICAL INC)
DrugClass IReported May 13, 2026 · Presence of Particulate Matter. - NAPROXEN ORAL SUSPENSION recall (Acella Pharmaceuticals, LLC)
DrugClass IIReported May 13, 2026 · Chemical contamination; presence of lead and lithium above specification - Duloxetine Delayed-Release Capsules USP recall (Breckenridge Pharmaceutical, Inc.)
DrugClass IIReported May 13, 2026 · CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Enalapril Maleate Tablets recall (JB Chemicals and Pharmaceuticals Ltd)
DrugClass IIReported May 13, 2026 · Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test - Octreotide Acetate for Injectable Suspension recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract... - BD PurPrep recall (CareFusion 213, LLC)
DrugClass IIReported May 13, 2026 · Lack of assurance of Sterility: potential product contamination - BD PurPrep recall (CareFusion 213, LLC)
DrugClass IIReported May 13, 2026 · Lack of assurance of Sterility: potential product contamination - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - DELFLEX recall (Fresenius Medical Care Holdings, Inc.)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Potential leaks from perforations in bags. - DELFLEX recall (Fresenius Medical Care Holdings, Inc.)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Potential leaks from perforations in bags. - busPIRone Hydrochloride Tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIIReported May 13, 2026 · Subpotent drug - ZENBONE recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - BioCera Fibers recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - Medline Surgical Packs: 1) PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See complete list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Surgical Drapes: 1) SHEET recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ARTHROSCOPY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT UROLOGY SLING recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK-CHOICE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT GENERAL CLOSURE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BURN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) WMC I D PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) HYSTEROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See full list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OB KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ADMIT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PPE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CVC PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LITHOTOMY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DYNDA3003 recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC LINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SCC RF PAIN MGMT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANCILLARY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - One Step P in vitro diagnostic test REF: 8194 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step K in vitro diagnostic test REF: 81A4 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Uric Acid in vitro diagnostic test REF: 31H0P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step pH in vitro diagnostic test REF: 31I4P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step UTI in vitro diagnostic test REF: 3374 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step 10A in vitro diagnostic test recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported May 13, 2026 · Respiratory/sore throat panel test may result in false negative results and control failures.