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 D-Dimer Test kits (1,218 units, all lots) distributed nationwide without FDA premarket approval. The unapproved test has not been reviewed by the FDA for safety and effectiveness.
The Ivenix Infusion System Large Volume Pump (Model LVP-0004) is being recalled because it may produce false occlusion alarms when used with a check valve at low infusion flow rates. Approximately 15,862 units are affected.
GET TESTED INTERNATIONAL AB is recalling its MPOX Test nationwide due to distribution without FDA premarket approval or clearance. Consumers who have purchased this test should not use it.
Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits because Test Card Lot TT241102 failed sensitivity testing, potentially resulting in false negative results that could miss blood in stool samples.
Philips has recalled 1,913,441 IntelliVue Patient Monitor MX450 units worldwide due to a potential issue where monitors may not alarm on critical patient conditions.
GET TESTED INTERNATIONAL AB is recalling its Fecal Occult Blood Test (all lots) distributed nationwide in the US without required FDA premarket approval, meaning the product's safety and effectiveness have not been verified.
Philips is recalling IntelliVue Multi Measurement Server X2 patient monitoring devices due to a potential issue where monitors may not alarm. Approximately 1.9 million units have been distributed worldwide.
GET TESTED INTERNATIONAL AB is recalling Men's Hormone Test kits distributed nationwide without FDA premarket approval or clearance. Consumers should stop using the product.
GET TESTED INTERNATIONAL AB distributed the Organic acids Test nationwide without FDA premarket approval. The Class II device is being recalled for failing to obtain required regulatory clearance before distribution.
Philips is recalling IntelliVue MP60 patient monitors due to a potential alarm failure. Approximately 1.9 million units distributed worldwide may fail to issue critical patient alerts.
A pregnancy test manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval or clearance. All lots are affected.
GET TESTED INTERNATIONAL AB's Leaky Gut Test was marketed without FDA premarket approval. The FDA initiated a recall affecting all units in nationwide distribution.
Philips IntelliVue Multi-Measurement Module X3 monitors may fail to sound critical alarms. The recall affects approximately 1.9 million units distributed worldwide.
GET TESTED INTERNATIONAL AB distributed the GI Microbiome Profile Small nationwide without FDA premarket approval. The test was not reviewed and cleared by FDA before distribution.
GET TESTED INTERNATIONAL AB's Chlamydia Test was distributed nationwide without FDA premarket approval or clearance. Users should not rely on test results and should consult a healthcare provider for proper diagnostic testing.
A 3 in 1 STI Test manufactured by GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval. Consumers should stop using the product and consult their healthcare provider.
GET TESTED INTERNATIONAL AB recalls its Lyme Test diagnostic device (940 units) distributed without FDA premarket approval. The device was distributed nationwide despite lacking required regulatory clearance.
GET TESTED INTERNATIONAL AB recalled 184 Menopause FSH 2 Tests nationwide because the devices were distributed without FDA premarket approval or clearance.
GET TESTED INTERNATIONAL AB is recalling the Iron Deficiency Test distributed nationwide because it was marketed without FDA premarket clearance. Consumers should stop using this unapproved device.
Illumina is recalling NextSeq 550Dx Reagent Kits due to a quality issue with flow cell gaskets that may cause leaks during DNA sequencing runs, potentially resulting in equipment malfunction and toxic substance exposure.
GET TESTED INTERNATIONAL AB is recalling a Herpes (HSV-1 & HSV-2) test distributed nationwide without FDA premarket approval. Consumers should stop using the product and consult a healthcare provider.
GET TESTED INTERNATIONAL AB is recalling its Cholesterol Test due to FDA determination that the device was distributed without required premarket approval or clearance.
Philips is recalling 1.9 million IntelliVue patient monitors due to a potential failure of the alarm function. The issue could prevent detection of patient deterioration.
Accriva Diagnostics is recalling Hemochron Activated Clotting Time Low-Range Test Cuvettes (Lot E5JLR132) because they may contain foreign objects with sharp edges that could injure users during handling.
GET TESTED INTERNATIONAL AB is recalling the Women's Hormone Test distributed nationwide because it was not approved by the FDA before distribution. The company must remove all units from the market.