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
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
Stradis Medical recalls surgical trays with incomplete outer bag seals that may breach kit sterility. No illnesses or injuries reported.
Stradis Medical is recalling Henry Schein Basic Extended Pack procedure kits due to incomplete sealing of the outer bag, which may compromise sterility. Products were distributed in the US and Canada.
Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.
DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.
Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.
DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed across 23 U.S. states.
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.
DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.
FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.
ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.
Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.
HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.
Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.
DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.