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 26001–26020 of 38,428 recalls

October 5, 2016· C.R. Bard, Inc.

Recalled Item: Magic3 Antibacterial Hydrophilic Intermittent Catheter

The Issue: Misbranding; the product labeled as an Antibacterial Hydrophilic

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)

The Issue: Vitamin D Total- Change in Correlation Between Serum

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Micro Therapeutics Inc, Dba Ev3 Neurovascular

Recalled Item: Pipeline Embolization Device (Pipeline Classic) The device is indicated for

The Issue: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating

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

Class I — Serious Health HazardTerminated
October 5, 2016· Micro Therapeutics Inc, Dba Ev3 Neurovascular

Recalled Item: Alligator Retrieval Device The device is intended for use in

The Issue: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating

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

Class I — Serious Health HazardTerminated
October 5, 2016· Micro Therapeutics Inc, Dba Ev3 Neurovascular

Recalled Item: X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300...

The Issue: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating

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

Class I — Serious Health HazardTerminated
October 5, 2016· Maquet Medical Systems USA

Recalled Item: Accessory Adapter Part number 600525A0 Product Usage: designed for the

The Issue: Maquet Inc. is initiating a voluntary field action

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Micro Therapeutics Inc, Dba Ev3 Neurovascular

Recalled Item: Marathon Flow Directed Micro Catheter

The Issue: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating

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

Class I — Serious Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated
October 5, 2016· Stryker Neurovascular

Recalled Item: Guider Softip XF

The Issue: Firm became aware of potentially defective Guider Guide

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

Class II — Potential Health HazardTerminated