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.

38,428 total recalls
0 this month

Showing 33721–33740 of 38,428 recalls

March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Fentanyl Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Morphine Strips (2000)

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Adenovirus Antigen Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Benzodiazepine Strip

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Fecal Occult Blood Test Strip

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Cocaine Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Methylphenidate Test Strip

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Dengue NS1 Ag/IgG/M Ab Duo Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Methamphetamine Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Methylphenidate Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Methadone Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: THC Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Legionella Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: PSA Test Card (Serum)

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Morphine Test Card (300)

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Fentanyl Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Tuberculosis Antibody Test Card Serum

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Ketamine Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Clonazepam Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Amphetamine Test Card

The Issue: Products shipped to US locations that do not

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated