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 33081–33100 of 38,428 recalls

May 20, 2014· Customed, Inc

Recalled Item: Face Lift

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 Arthroscopy 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: LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS

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- (1) TABLE COVER REINFORCED 50" X 90" (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: LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS

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: FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57"

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 Angiodrape Pack convenience pack include multiple components:...

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: TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL 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: PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30"

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 ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG.

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: Breast pack TPSC

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 - (1) MAYO STAND COVER REINFORCED LIF (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: CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 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: GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 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 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: BASIC COSMETIC SURG. PACK CUSTOMED (USA)

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: PERl GYN PACK (1) TABLE COVER 44" x 90" (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: NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (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: NEURO SPINE 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: EAR PACK CONTENTS: ( I ) B LADE SU RG

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