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 33221–33240 of 38,428 recalls

May 20, 2014· Customed, Inc

Recalled Item: PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF

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: CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 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: Face Pack FJG

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 - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL

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: LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (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: FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" 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 PACK Ill (4) CUSTOMED CONTENT: (4) 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: Tummy Tuck and Liposuction 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: O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I)

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: 0.B. PACK - - (1) TABLE COVER 44" 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: ORTHOPEDIC PACK I (2) CUSTOMED

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· Siemens Healthcare Diagnostics, Inc.

Recalled Item: syngo Lab Data Manager

The Issue: Certain configuration parameters may cause the reference ranges

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

Class II — Potential Health HazardTerminated
May 19, 2014· KCI USA, Inc.

Recalled Item: CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

The Issue: Blade can shift during shipping which makes the

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

Class II — Potential Health HazardTerminated
May 19, 2014· Small Bone Innovations

Recalled Item: Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw...

The Issue: Small Bone Innovations (SBi) is recalling all lots

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

Class II — Potential Health HazardTerminated
May 19, 2014· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: V-Series Patient Monitoring System

The Issue: ECG interpretation feature issues. False measurements reported when

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

Class II — Potential Health HazardTerminated
May 19, 2014· Zimmer, Inc.

Recalled Item: NexGen Complete Knee Solution

The Issue: Zimmer is initiating a voluntary recall of specific

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

Class II — Potential Health HazardTerminated
May 19, 2014· Zimmer, Inc.

Recalled Item: NexGen Complete Knee Solution

The Issue: Zimmer is initiating a voluntary recall of specific

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

Class II — Potential Health HazardTerminated
May 19, 2014· Zimmer, Inc.

Recalled Item: NexGen Complete Knee Solution

The Issue: Zimmer is initiating a voluntary recall of specific

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

Class II — Potential Health HazardTerminated
May 19, 2014· Zimmer, Inc.

Recalled Item: NexGen Complete Knee Solution

The Issue: Zimmer is initiating a voluntary recall of specific

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

Class II — Potential Health HazardTerminated
May 19, 2014· Zimmer, Inc.

Recalled Item: NexGen Complete Knee Solution

The Issue: Zimmer is initiating a voluntary recall of specific

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

Class II — Potential Health HazardTerminated