Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IISperm Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIVitamin D-Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIVaginal PH Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIUrinary Tract Infection Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IITrichomonas Vaginalis test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIThyroid TSH Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IISyphilis Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IISperm Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIPregnancy Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIParasite Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIOvulation Test (5 tests)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMPOX Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMenopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IILyme Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIron Deficiency Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIHPV Antigen Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIHerpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIH pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIGonorrhea test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFemale Fertility Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFecal Occult Blood Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IID-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IICandida Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIBlood Type Test
Distribution without premarket approval/clearance.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief