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 33741–33760 of 38,428 recalls
Recalled Item: PSA Test Card (Whole Blood)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CK-MB Test Card (serum)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Troponin I test Card (serum)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2 (synthetic Marijuana) Test Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotavirus Test Card LumiQuick
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H. Pylori Antibody Test Card (Whole Blood) LumiQuick
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCP Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Methamphetamine Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salmonella typhi IgG/IgM Duo Test
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Troponin I test Card (Whole Blood)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myoglobin Test Card (Whole Blood)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2 (synthetic Marijuana) Test card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Benzodiazepine Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syphilis Test Strip (Serum) LumiQuick
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Panel Test (Serum)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fecal Occult Blood Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barbiturate Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Buprenorphine Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxycodone Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dengue NS1 Antigen Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.