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 22681–22700 of 38,428 recalls

October 16, 2017· DeRoyal Industries Inc

Recalled Item: DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep

The Issue: Custom surgical kits contain Aplicare Povidone Iodine Prep

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

Class II — Potential Health HazardTerminated
October 14, 2017· Medtronic Minimally Invasive Therapies Group

Recalled Item: MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis

The Issue: Medtronic is voluntarily recalling one lot of its

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Coons Interventional Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Movable Core Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Amplatz Ultra Stiff Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Amplatz Extra Stiff Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Bentson Cerebral Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Femoral Artery Pressure Monitoring Set

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Reuter Tip Deflecting Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Amplatz Stiff Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Double Flexible Tipped Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Left Atrial Catheter Set

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Bentson Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Amplatz Extra Stiff Whisker Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Tray

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Fixed Core Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Bentson Plus Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Disposable Reuter Tip Deflecting Wire Guide

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: Fixed Core Bentson

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated
October 13, 2017· Cook Inc.

Recalled Item: TFE Coated Curved Newton LLT

The Issue: Label does not state that the product is

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

Class II — Potential Health HazardTerminated