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
GET TESTED INTERNATIONAL AB is recalling the Vaginal pH Test due to distribution without premarket FDA approval. The product was distributed nationwide without required FDA clearance.
GET TESTED INTERNATIONAL AB is recalling its Food Sensitivity Test Large due to distribution without premarket FDA approval. The product was distributed nationwide without FDA clearance for safety and effectiveness.
Siemens MAMMOMAT Fusion operator table units were incorrectly sold with a bus-installation kit. The operator table is designed only for stationary operation and is not released for bus transport or installation.
GET TESTED INTERNATIONAL AB distributed the Gut Microbiome Test Small nationwide without FDA premarket approval or clearance. Consumers should stop using the product.
Paragon 28 is recalling the Phantom Fibula Nail due to out-of-specification thread depths that may prevent proper mating with instrumentation, potentially requiring surgery to be aborted.
Philips is recalling CT 5300 scanners due to loose screws on the tube heat exchanger component. If not properly tightened during replacement, the heat exchanger may detach and damage other internal components during operation.
Philips IntelliVue Patient Monitor MX500 units may fail to generate alarms when configured to do so. Approximately 1.9 million units worldwide are affected by this FDA Class II recall.
GET TESTED INTERNATIONAL AB is recalling the DHEA Test (all lots) that was distributed nationwide in the US without required FDA premarket approval or clearance.
Food Intolerance Test Medium was distributed nationwide without FDA premarket approval or clearance. The product requires regulatory review before being sold in the United States.
GET TESTED INTERNATIONAL AB is recalling the Mycotoxin Panel Test because it was distributed without FDA premarket approval. Consumers should stop using the product.
Philips is recalling Incisive CT systems with software versions 4.5, 5.0, and 5.1 because tube heat exchanger screws may become loose after replacement, potentially causing component detachment and internal damage.
GET TESTED INTERNATIONAL AB is recalling Iodine Test units distributed nationwide due to distribution without FDA premarket approval or clearance. No illnesses or injuries have been reported.
GET TESTED INTERNATIONAL AB distributed the Heavy Metals Test nationwide without FDA premarket clearance. The company is recalling all 50 units across all lots.
Philips is recalling approximately 1.9 million IntelliVue MP40 patient monitors that may fail to sound alarms. Affected units were distributed worldwide to healthcare facilities.
GET TESTED INTERNATIONAL AB is recalling the Intestinal Worms Test (all lots) distributed nationwide without FDA premarket approval. The device has not undergone required regulatory review.
GET TESTED INTERNATIONAL AB recalled all 60 units of its Trichomonas Vaginalis diagnostic test distributed nationwide in the US without FDA premarket approval or clearance.
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.