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
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.
Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.
Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.
Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.
The Cardiosave Hybrid Intra-Aortic Balloon Pump software update version D.00 includes instructions with incorrect annotations about compliance to standard 60601-1-12:2014. Four units were distributed in Germany.
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
A software anomaly in Medtronic's StealthStation Cranial Software may cause inaccurate surgical navigation during brain procedures. This can result in unintended tissue damage and prolonged surgery.
Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.
Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.
A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.
The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.
BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.
Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.
DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.
DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.
DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.
C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.
Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.
Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.
Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.
Avanos Medical recalls some AVNS ambIT System catheter kits that were potentially distributed without an air in-line filter. Affected units were distributed worldwide, including in Texas, Oregon, and Australia.
DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.
Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.