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 35321–35340 of 38,428 recalls

June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 16, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging...

The Issue: Faulty SurgiCounter Charging Cradle can prevent the scanner

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

Class II — Potential Health HazardTerminated
June 14, 2013· PIONEER SURGICAL TECHNOLOGY, INC.

Recalled Item: Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE

The Issue: The affected fixed rod holders did not allow

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

Class II — Potential Health HazardTerminated
June 14, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic Affinity Pediatric Arterial Filter

The Issue: Medtronic is recalling 148 Affinity Pediatric Arterial Filters

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated
June 14, 2013· Biomerieux Inc

Recalled Item: bioMerieux Vitek 2 Systems Software version 6.01 software

The Issue: A product issue has been identified for customers

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

Class II — Potential Health HazardTerminated