Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.
Permobil TiLite wheelchairs (Models Aero Z and ZRA) used as vehicle passenger seats may not be properly oriented during motor vehicle accidents due to transit tie-down configuration issues. Consumers should discontinue use as passenger seats until replacement tie-downs are installed.
Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.
Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.
CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.
ROi CPS LLC recalled 1,200 REGARD Core Biopsy Trays distributed nationwide because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications.
Laboratoires Bodycad is recalling its Torque Limiting Adaptor AO Connect due to risk of breakage if used counterclockwise and lack of validation for power tool use. Approximately 10 units were distributed to facilities in Colorado, Michigan, and New York.
Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.
Therakos is recalling 15 photopheresis kits because they were released before testing was completed. If used, a drive tube leak could cause illness or injury.
Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.
McKesson PREVENT HT Safety Winged Blood Collection Needles may have difficulty activating their safety mechanism. The recall affects units distributed nationwide.
McKesson PREVENT HT blood collection needles with specific lot numbers may have difficulty activating their safety mechanism. Healthcare facilities should contact the manufacturer for replacement guidance.
Baxter's Hemodialysis Delivery System may incorrectly revert to old prescription values when operators change prescriptions after filter changes, potentially resulting in incorrect treatment parameters.
Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.
Henry Schein safety blood collection needles may have difficulty activating their safety mechanism, potentially increasing needlestick injury risk. Affected lots were distributed nationwide with expiration dates through late 2025.
Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.
Z-Medica is recalling 2400 units of QuikClot Combat Gauze due to potential packaging seal failures that could compromise sterile barrier integrity. Affected lot 12645 was distributed nationwide.
Nationwide recall of McKesson PREVENT HT Safety Blood Collection Needles (22G 1 1/4 inch) due to potential difficulty activating the safety mechanism. The protective feature may fail to engage properly during use.
McKesson PREVENT HT Safety Blood Collection Needles are being recalled due to potential difficulty in activating the safety mechanism. The recall affects needles distributed nationwide, including specific lot numbers with expiration dates through May 2025.
Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.
Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.