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 641–660 of 38,428 recalls
Recalled Item: D-Dimer Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diabetes HbA1c Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Candida Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syphilis Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iodine Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MPOX Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GI Microbiome Profile Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parasite Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sperm Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DHEA Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Serotonin Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Female Fertility Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gut Microbiome Test Mega
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Allergy Panel Test (IgE)
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Intolerance Test Large
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAD Profile Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitamin D2 and D3 Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leaky Gut Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kidney Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2 in 1 Trichomonas / Gardnerella Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.