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 27301–27320 of 38,428 recalls

April 15, 2016· Cook Inc.

Recalled Item: Haskal Transjugular Intrahepatic Portal Access Set Introducer

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: Liver Access and Biopsy Needle Set Biopsy needle kit Intended

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: Selective Salpingography Catheter with Beacon Tip Cannula

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: Slip-Cath Beacon Tip Catheter Catheter

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: Transluminal Biliary Biopsy Forceps Set Forceps

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Cook Inc.

Recalled Item: White Lumax Guiding Coaxial Catheter Catheter

The Issue: Increase in reports of polymer degradation of the

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: TM LPS TIB SZ 3 C/D

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: TM MONO TIB STR GRN SZ 5 - 00588606510 TM

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: TM CR TIB SZ 3 C-H

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· Zimmer Trabecular Metal Technology, Inc.

Recalled Item: 00720504022 ACETAB.CUPW/SH

The Issue: Zimmer Biomet is initiating a recall of specific

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

Class II — Potential Health HazardTerminated
April 15, 2016· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: non-recoverable loss of image acquisition. The affected

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

Class II — Potential Health HazardTerminated
April 15, 2016· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: non-recoverable loss of image acquisition. The affected

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

Class II — Potential Health HazardTerminated
April 15, 2016· Covidien LLC

Recalled Item: Given Imaging Bravo¿ pH capsule delivery device

The Issue: of an allergic reaction in a patient

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

Class II — Potential Health HazardTerminated
April 15, 2016· Covidien LLC

Recalled Item: Given Imaging Bravo¿¿ pH capsule delivery device

The Issue: of an allergic reaction in a patient

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

Class II — Potential Health HazardTerminated
April 15, 2016· Carestream Health Inc

Recalled Item: CARESTREAM Image Suite V4

The Issue: Carestream Health received a complaint related to CARESTREAM

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

Class II — Potential Health HazardTerminated
April 15, 2016· Carestream Health Inc

Recalled Item: CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490

The Issue: Carestream Health received a complaint related to CARESTREAM

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

Class II — Potential Health HazardTerminated
April 14, 2016· Randox Laboratories, Limited

Recalled Item: Magnesium on RX Imola analyser IVD

The Issue: According to the firm, Carry over was observed

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

Class II — Potential Health HazardTerminated