FDA medical device recalls
Formal FDA enforcement reports for medical devices — implants, monitors, diagnostic tests, and hospital and home-use equipment.
2,600 recalls in the last 12 months, translated into plain English.
- 2025-12-10Get TestedClass IITrichomonas Vaginalis test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIThyroid TSH Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISyphilis Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISperm Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIPregnancy Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIParasite Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIOvulation Test (5 tests)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMPOX Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIMenopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IILyme Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIron Deficiency Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIHPV Antigen Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIHerpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIH pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIGonorrhea test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFemale Fertility Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIFecal Occult Blood Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IID-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IICandida Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIBlood Type Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIAlcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
- 2025-12-10MedtronicClass IIAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-12-10EnterixClass IIInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- 2025-12-10Fresenius KabiClass IIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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