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 33701–33720 of 38,428 recalls

March 4, 2014· LumiQuick Diagnostics Inc.

Recalled Item: Buprenorphine 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: Morphine Strip (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: Tramadol 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: Propoxyphene 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: Myoglobin 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: Cocaine 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: Syphilis Test Card Whole Blood(Serum) LumiQuick

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: Syphilis 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: CK-MB 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.

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

Recalled Item: Drugs of Abuse Panel Test Device

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 (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: Alcohol Test

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: MDMA/Ecstasy 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: Adeno/Rota Combo 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 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: MDMA/Ecstasy 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: Strep A 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· Teleflex Medical

Recalled Item: Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800

The Issue: Sterility of the product cannot be guaranteed

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

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

Recalled Item: Malaria pan Antigen Test

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 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