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
Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.
Trackx Technology is recalling 464 units of its Insight Base Modular Instrument Tracker because the device breaks and falls off from surgical instruments during procedures. No injuries have been reported.
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
Medline recalls sterile procedural trays because blades may puncture the foil packaging, potentially compromising sterility. The recall affects over 227,000 units distributed worldwide.
The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.
Medline Industries is recalling multiple sterile procedural trays because blades within the kits can puncture the outer foil packaging. The products were distributed worldwide.
Quest Medical recalls Precision Delivery Sets (models PD06F and PDT05CV2) due to tubing that may detach, potentially causing patient infection. Approximately 13,900 units were distributed nationwide.
Medline Industries is recalling Ambulatory Mini Pack sterile procedural trays because blades within the kits may puncture the outer sterile packaging, potentially compromising sterility.
Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.
Medline recalls sterile surgical trays (Universal Plastic and Knee Arthroscopy Pack) because sterile blades can puncture the outer foil packaging, potentially compromising sterility.
Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.
Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.
Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.
Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.
Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.
FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.
Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.