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 15061–15080 of 38,428 recalls

May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 6, 2020· Endologix, Inc.

Recalled Item: Ovation iX Abdominal Stent Graft Systems

The Issue: A material weakness adjacent to the polymer fill

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

Class I — Serious Health HazardTerminated
May 5, 2020· Olympus Corporation of the Americas

Recalled Item: ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use

The Issue: Products repaired with the incorrect service manual may

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated
May 5, 2020· Zimmer Biomet, Inc.

Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM

The Issue: There are reports of inadequate locking of the

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

Class II — Potential Health HazardTerminated