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 28061–28080 of 38,428 recalls

January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Biomet France SARL

Recalled Item: Endobon-Xenograft Granules

The Issue: Cytotoxicity tests were not passed at 36 months

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

Class II — Potential Health HazardTerminated
January 20, 2016· Zimmer Biomet, Inc.

Recalled Item: Herga foot switch

The Issue: Complaints were received reporting the system would freeze/shut

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

Class II — Potential Health HazardTerminated
January 20, 2016· Magellan Diagnostics, Inc.

Recalled Item: LeadCare II Blood Lead Test Kit

The Issue: LeadCare II Test Kits controls out of range

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

Class II — Potential Health HazardTerminated
January 20, 2016· AGFA Healthcare Corp.

Recalled Item: AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for

The Issue: The DX-D100 User Manual already contained information about

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: Incorrect packaging. Reports of packages labeled as 6.0Fr

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated
January 20, 2016· Integrated Medical Systems Inc

Recalled Item: Olympus

The Issue: If excessive pressure is applied to the distal

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

Class II — Potential Health HazardTerminated