Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 661–680 of 38,428 recalls
Recalled Item: Menopause (FSH) 2 Tests
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Type Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3 in 1 STI Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biological Age & Longevity Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lyme Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drug Test Small (4 substances)
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Organic acids Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hair Mineral Analysis
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gut Microbiome Test Large
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chlamydia Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gonorrhea test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cholesterol Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iron Deficiency Test (ferritin)
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thyroid TSH Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herpes (HSV-1 & HSV-2) Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iron Deficiency Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diabetes Test (ketones & glucose)
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liver Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pregnancy Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allergy & Food Intolerance Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.