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
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
Pending LLM rewrite. Source: FDA_DEVICE Z-0579-2023.
Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.
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.
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.
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.
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
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.
Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
DeRoyal CRANI PACK procedure kits are being recalled because they contain 3M Health Care Steri Drapes that were previously recalled. Affected kits were distributed to medical facilities across multiple U.S. states.
DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.
Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.