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 32101–32120 of 38,428 recalls

October 8, 2014· Customed, Inc

Recalled Item: Gown Cool Impervious XLGE Breathable

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: Bandeja para Debridacion (Debridement 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: Suction Catheter 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: Neuro 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: Labor & Delivery 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: Laparoscopy Gyn 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: Cesarean 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: Peri 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: Major Lap 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: Peri Gyn 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: Neuro 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: Retina 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: Neuro Spine 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: Carpal Tunnel Surgical Large 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: Tummy Tuck &#38

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 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: Labor & Delivery 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