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 37921–37940 of 38,428 recalls

March 23, 2012· B. Braun Medical, Inc.

Recalled Item: Space Pump Pole Clamps for the Infusomat Space Pump

The Issue: Firm has become aware of the potential for

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

Class II — Potential Health HazardTerminated
March 23, 2012· Biomet 3i, LLC

Recalled Item: ******Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by

The Issue: Biomet 3i is recalling their product Full Osseotite

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

Class II — Potential Health HazardTerminated
March 23, 2012· B. Braun Medical, Inc.

Recalled Item: Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly

The Issue: Firm became aware of the potential for breakage

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

Class I — Serious Health HazardTerminated
March 23, 2012· Colgate Palmolive Company

Recalled Item: Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush

The Issue: Brush battery cap was forcibly blown off at

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

Class II — Potential Health HazardTerminated
March 23, 2012· Colgate Palmolive Company

Recalled Item: Colgate Adult Motion Battery Toothbrush Dist. by Colgate-Palmolive

The Issue: Brush battery cap was forcibly blown off at

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

Class II — Potential Health HazardTerminated
March 23, 2012· Colgate Palmolive Company

Recalled Item: Colgate 360 Replaceable Head Battery Powered Toothbrush Soft

The Issue: Brush battery cap was forcibly blown off at

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

Class II — Potential Health HazardTerminated
March 23, 2012· Colgate Palmolive Company

Recalled Item: Colgate 360 Replaceable Head Battery Powered Toothbrush Medium Dist.

The Issue: Brush battery cap was forcibly blown off at

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

Class II — Potential Health HazardTerminated
March 23, 2012· Colgate Palmolive Company

Recalled Item: Colgate Adult Motion Whitening Battery Toothbrush Dist. by

The Issue: Brush battery cap was forcibly blown off at

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

Class II — Potential Health HazardTerminated
March 22, 2012· Extremity Medical LLC

Recalled Item: Extremity Medical

The Issue: Lag screw measurement is short (approximately 5 mm)

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

Class II — Potential Health HazardTerminated
March 22, 2012· Tripath Imaging, Inc.

Recalled Item: PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523

The Issue: The PrepStain Syringing Pipettes may not dispense the

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

Class III — Low RiskTerminated
March 22, 2012· Tripath Imaging, Inc.

Recalled Item: PrepStain Syringing Pipettes 240 (Catalog #490517)

The Issue: The PrepStain Syringing Pipettes may not dispense the

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

Class III — Low RiskTerminated
March 22, 2012· Tripath Imaging, Inc.

Recalled Item: Manual Method 1: 480 Test Kit (PreCoat)

The Issue: The PrepStain Syringing Pipettes may not dispense the

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

Class III — Low RiskTerminated
March 22, 2012· Tripath Imaging, Inc.

Recalled Item: PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit

The Issue: The PrepStain Syringing Pipettes may not dispense the

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

Class III — Low RiskTerminated
March 22, 2012· Tripath Imaging, Inc.

Recalled Item: PrepStain Installation Kit (PreCoat)

The Issue: The PrepStain Syringing Pipettes may not dispense the

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

Class III — Low RiskTerminated
March 19, 2012· Impact Instrumentation, Inc.

Recalled Item: Model 731 EMV+ Uni-Vent

The Issue: Ten units of Model EMV+ Devices were shipped

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

Class III — Low RiskTerminated
March 15, 2012· Sunquest Information Systems, Inc.

Recalled Item: Sunquest Laboratory Sunquest Laboratory is intended for use by professionals

The Issue: Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through

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

Class II — Potential Health HazardTerminated
March 14, 2012· Surgical Tissue Network, Inc.

Recalled Item: UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description:

The Issue: Surgical Tissue Network Inc., DBA TissueNet Inc. recalled

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

Class II — Potential Health HazardTerminated
March 14, 2012· Surgical Tissue Network, Inc.

Recalled Item: UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description:

The Issue: Surgical Tissue Network Inc., DBA TissueNet Inc. recalled

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

Class II — Potential Health HazardTerminated
March 14, 2012· Surgical Tissue Network, Inc.

Recalled Item: Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description:

The Issue: Surgical Tissue Network Inc., DBA TissueNet Inc. recalled

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

Class II — Potential Health HazardTerminated
March 13, 2012· Medtest Holdings, Inc.

Recalled Item: Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two

The Issue: Decrease reactivity of R 1 component

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

Class II — Potential Health HazardTerminated