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 33061–33080 of 38,428 recalls

May 20, 2014· Customed, Inc

Recalled Item: HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL

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 GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS

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: C-SECTION SURGICAL PACK- (1) COVER TABLE 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
May 20, 2014· Customed, Inc

Recalled Item: PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free

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: DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER

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 - (1) CIRUGIA CARDIOVASCULAR (PREPARACION)

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 - (6) 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: LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (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: O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES

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 (I) (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: LUMBAR 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: PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X

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 BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X

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: Endovascular 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: General Cosmetic Pack FCSC

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 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: Chole Cystectomy All Endo System

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- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON

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) 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: ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) 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