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
Philips is recalling the IntelliVue Patient Monitor MX100 due to a potential issue where the device may not sound alarms. The recall affects approximately 1.9 million units distributed worldwide.
Medtronic Aurora EV-ICD and Clinical EV-ICD implantable defibrillators may experience delayed high-voltage therapy delivery under rare circumstances. No patient injuries have been reported.
GET TESTED INTERNATIONAL AB distributed a medical device without FDA premarket approval or clearance. The device was distributed nationwide in the United States.
GET TESTED INTERNATIONAL AB is recalling its Diabetes Test kit (ketones & glucose) because it was distributed nationwide without FDA premarket approval. Consumers should discontinue use and consult their healthcare provider.
Aizu Olympus is recalling 6,578 units of the Olympus OER-Mini medical device distributed nationwide. Customers must be informed about safety warnings, maintenance schedules, and the requirement that only trained personnel perform repairs.
Microbiologics Inc is recalling KWIK-STIK quality control kits due to labeling errors. Some units from lot 818-111-7 were packaged in containers labeled with an incorrect lot number.
Adrenal Test kits distributed nationwide by GET TESTED INTERNATIONAL AB are being recalled because they were distributed without FDA premarket approval or clearance. Users should discontinue use immediately.
GET TESTED INTERNATIONAL AB is recalling Syphilis Test kits (528 units, all lots) that were distributed nationwide without FDA approval or clearance. The device was marketed without required regulatory authorization.
The FDA has recalled the Gut Microbiome Test Mega, a medical device manufactured by GET TESTED INTERNATIONAL AB, for distribution without premarket approval or clearance. The product was distributed nationwide.
Food Sensitivity Test Small kits are recalled for distribution without FDA premarket approval or clearance. Consumers should stop using and contact the manufacturer.
Siemens is recalling MAMMOMAT Revelation mammography systems where the operator table was sold together with a bus-installation kit, despite being designed for stationary operation only.
GET TESTED INTERNATIONAL AB is recalling its Fructose Intolerance Test because the product was distributed in the United States without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB recalls its Vitamin D2 and D3 Test (EAN: 7340221709232) distributed nationwide without FDA premarket approval. All lots are affected.
GET TESTED INTERNATIONAL AB is recalling its Allergy & Food Intolerance Test (all lots) because it was distributed nationwide without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling Ovulation Test (5 tests) nationwide due to distribution without FDA premarket approval or clearance.
Aizu Olympus is notifying customers of Olympus OER-Pro devices about important safety warnings and maintenance procedures. Only trained personnel should perform repairs and maintenance.
GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test distributed nationwide without FDA premarket approval or clearance.
A drug test device (4 substances) manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket clearance. Consumers should discontinue use and consult a healthcare provider.
GET TESTED INTERNATIONAL AB's Sperm Test (EAN 7340221710221, all lots) was distributed nationwide without required FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling the Sorbitol Intolerance Test distributed nationwide because it was sold without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling 658 units of Parasite Test distributed nationwide without FDA premarket approval. The device lacks FDA validation for safety and effectiveness.
GET TESTED INTERNATIONAL AB is recalling Gut Microbiome Test Medium nationwide because the product was distributed without FDA premarket approval. Consumers should discontinue use.
GET TESTED INTERNATIONAL AB is recalling Peptic Ulcer Test (H. pylori) due to distribution without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider.
GET TESTED INTERNATIONAL AB is recalling Gut Microbiome Test XL nationwide because the device was distributed without FDA premarket approval or clearance. Consumers should discontinue use and contact the manufacturer.
GET TESTED INTERNATIONAL AB is recalling the Food Intolerance Test Large (EAN: 616612785640) that was distributed nationwide without FDA premarket approval or clearance.