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 33021–33040 of 38,428 recalls

May 20, 2014· Customed, Inc

Recalled Item: ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110"

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: Laparoscopy pack

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24"

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: Cirugia Cardiovascular Case Cart

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: Liposuction Pack BOD

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90"

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH.

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: Face Pack MRT

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4)

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: TLIF PACK SURGICAL CENTER

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: 08 PAD PACK II (2

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated
May 20, 2014· Customed, Inc

Recalled Item: REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15"

The Issue: Customed has determined that there is the possibility

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

Class I — Serious Health HazardTerminated