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 32021–32040 of 38,428 recalls

October 8, 2014· Customed, Inc

Recalled Item: Arthroscopy 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: Universal 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: Universal 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: Incision & Drainage 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: Orthopedic 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: Cysto Tur 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: Angiography 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: Open Heart 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: Mayo Stand Cover W/CSR Wrap

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: Tracheotomy Care Kit

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: Angiodrape 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: Arthroscopy 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: Laparoscopy OB GYN 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: Gown Surgical Poly Reinforced XL X-Long

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: Cirugia Cardiovascular Case Cart

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: Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray

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: Premium Cesarean 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: Breat Pack-TPSC

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: 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: Gown Surgical Fabric Reinforced XL

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