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 621–640 of 38,428 recalls
Recalled Item: Gut Microbiome Test XL
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pet Allergy Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urinary Tract Infection Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactose Intolerance Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSA Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gut Microbiome Test Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8 in 1 STI Test Kit
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Akkermansia Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mycotoxin Panel Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Intolerance Test Medium
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Sensitivity Test Large
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IVENIX INFUSION SYSTEM
The Issue: Incorrect assembly of specific lot of LVP Primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Sensitivity Test Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allergy test Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peptic Ulcer Test (H
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heavy Metals Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fructose Intolerance Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trichomonas Vaginalis test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIBO Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intestinal Worms Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.