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 12561–12580 of 38,428 recalls

April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System

The Issue: There is a potential for the screw blocking

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

Class II — Potential Health HazardTerminated
April 26, 2021· Meta C.G.M. Spa

Recalled Item: MICROSS

The Issue: Sterility issues; single use devices labeled as sterile

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

Class II — Potential Health HazardTerminated
April 26, 2021· LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Recalled Item: Leccurate SARS-CoV-2

The Issue: Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold

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

Class I — Serious Health HazardCompleted
April 26, 2021· Meta C.G.M. Spa

Recalled Item: SMARTSCRAPER CE0123

The Issue: Sterility issues; single use devices labeled as sterile

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

Class II — Potential Health HazardTerminated
April 26, 2021· Meta C.G.M. Spa

Recalled Item: SAFESCRAPER TWIST

The Issue: Sterility issues; single use devices labeled as sterile

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

Class II — Potential Health HazardTerminated
April 26, 2021· Meta C.G.M. Spa

Recalled Item:

The Issue: Sterility issues; single use devices labeled as sterile

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

Class II — Potential Health HazardTerminated
April 26, 2021· Roche Diagnostics Operations, Inc.

Recalled Item: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER

The Issue: Roche received several complaints regarding increased control recovery

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

Class II — Potential Health HazardOngoing
April 23, 2021· Synaptive Medical Inc

Recalled Item: Synaptive Trackable Suction Set Standard and Malleable

The Issue: Due to visible burrs/metal filings affixed along the

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

Class II — Potential Health HazardTerminated