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 33001–33020 of 38,428 recalls

May 20, 2014· Customed, Inc

Recalled Item: E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) 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: Laparotomy 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 COLORECTAL SURGICAL PACK code 900-2259A

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) DRAPE LAP ABDOMINAL WITH POUCH (1)

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: ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) 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
May 20, 2014· Customed, Inc

Recalled Item: PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102"

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 OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN

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 1116FR. - CUSTOM ED- (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: ACDFPACK 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: UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE

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: Shoulder 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: Liposuction 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: ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) 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: RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78"

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: CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20"

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: Customed O.B. Pack convenience pack include multiple components: set up cover

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: Customed Femoral 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: Urology 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: ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP

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: O.B. PACK - (I) TABLE COVER REINFORCED 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