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
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.
Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate (dialysis product) due to incorrect labeling. The label misidentifies 5.62g/L as potassium chloride when it actually represents calcium chloride, though the product itself is potassium-free.
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps and insulin pumps.
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion pumps.
Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.
Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.
Hillrom Centrella Hospital Beds with WatchCare systems may emit radio frequency signals that interfere with other medical devices. Approximately 6,407 units are affected and distributed in the US.
Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.
SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.
Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.
Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.
The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.
Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical kits were distributed nationwide.
MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.
Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.
Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.