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 32061–32080 of 38,428 recalls

October 8, 2014· Customed, Inc

Recalled Item: Gown Surgical Non 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
October 8, 2014· Customed, Inc

Recalled Item: Strabismus And Plastic 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 Colorectal 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: Laparoscopy and Pack (1)(2)

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: Surgical packs (includes trays

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: 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: Transverse Laparotomy Pack (8)

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: Reyito Urological 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: 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: 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: Shoulder 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: Basic Pack 1 (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: Arthroscopy 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: Utility Drape End Product

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: 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 Cholecystectomy 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: 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: Hip &#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: 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: 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