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 32081–32100 of 38,428 recalls

October 8, 2014· Customed, Inc

Recalled Item: Arthoscopy Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Laparotomy Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Gown Impervious Extra Long X-Large with Towel & Wrap

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Laparoscopy Chole Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Ophtalmic Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Higado & Pancrea Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Basic Pack W/Out Gown

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Wound Management Tray II

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Leggings W/7'' Cuff

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: General Line Full Body Drape

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Pediatric Lap Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: ENT Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Laparoscopy Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: D&C Laparoscopy Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Ear Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Liposuction Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Wound Management Tray

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Laparoscopy Chole Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Urology Pack

The Issue: Customed products are being recalled because of compromised

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

Class I — Serious Health HazardTerminated
October 8, 2014· Customed, Inc

Recalled Item: Plastic Surgery Pack

The Issue: Significant compromised sterility, not limited to potentially damaged

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

Class I — Serious Health HazardTerminated