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 32961–32980 of 38,428 recalls

May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage:

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage:

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage:

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage:

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 5.0mm Barrel Bur Sterile

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 22, 2014· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Lindemann Drill Short

The Issue: There may be missing notches, partial notches or

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

Class II — Potential Health HazardTerminated
May 21, 2014· Brainlab AG

Recalled Item: Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is

The Issue: Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1

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

Class II — Potential Health HazardTerminated
May 21, 2014· Roche Diagnostics Operations, Inc.

Recalled Item: cobas 6000 analyzer series Operators Manual Roche cobas

The Issue: Under certain conditions loose ProCell/CleanCell aspiration tube filters

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

Class II — Potential Health HazardTerminated