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 32121–32140 of 38,428 recalls

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: 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: Laparotomy 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: Laparotomy Basic 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: Femoral 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: Fanfold 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: Cystoscopy Pack III

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: Total Hysterectomy

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 Surgical Non Reinforced XXL

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: Femoral 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: 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: 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: Premium OB 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 Surgical 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: Umbilical Vessel 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: 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: Uretheral Catheter 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: Irrigation Tray With Bulb Syringe

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: Transforaminal Lumbar Interbody Fusion (TLIF) 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: Major Laparotomy 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