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 24121–24140 of 38,428 recalls

April 28, 2017· Zimmer Biomet, Inc.

Recalled Item: R-F IM NAIL 10MMDX48CM LG

The Issue: Zimmer Biomet is initiating a field action for

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

Class II — Potential Health HazardTerminated
April 28, 2017· Exact Sciences Corporation

Recalled Item: Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use.

The Issue: Exact Sciences is correcting all Sample Mixer v2

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

Class II — Potential Health HazardTerminated
April 28, 2017· KCI USA, INC.

Recalled Item: 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy

The Issue: sterile barrier breach

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

Class II — Potential Health HazardTerminated
April 28, 2017· Arrow International Inc

Recalled Item: Arrow(R) VPS(R) Access Kit for use with 4 and 5

The Issue: Arrow International is notifying each customer who received

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

Class II — Potential Health HazardTerminated
April 28, 2017· Zimmer Biomet, Inc.

Recalled Item: NexGen Offset Stem Extension

The Issue: Zimmer Biomet is conducting a lot-specific medical device

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

Class II — Potential Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated
April 27, 2017· Vyaire Medical

Recalled Item: AirLife Resuscitation

The Issue: The mask component on various lots of the

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

Class I — Serious Health HazardTerminated