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 38001–38020 of 38,428 recalls

January 20, 2012· Beckman Coulter Inc.

Recalled Item: COULTER PrepPlus

The Issue: The recall was initiated because Beckman Coulter has

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

Class II — Potential Health HazardTerminated
January 19, 2012· Nihon Kohden America Inc

Recalled Item: MEE-1000A Neuromaster

The Issue: The MEE-1000A Neuromaster had defective printed circuit boards

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

Class II — Potential Health HazardTerminated
January 13, 2012· Stryker Spine

Recalled Item: Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS

The Issue: Beginning in February 2011, Stryker Spine began receiving

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

Class II — Potential Health HazardTerminated
January 10, 2012· Vital Scientific N.V.

Recalled Item: Selectra ProS Analyzer

The Issue: The action was initiated due power supply failure

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

Class II — Potential Health HazardTerminated
January 10, 2012· Vital Scientific N.V.

Recalled Item: Viva - JR

The Issue: The action was initiated due power supply failure

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

Class II — Potential Health HazardTerminated
January 10, 2012· Vital Scientific N.V.

Recalled Item: V-Twin

The Issue: The action was initiated due power supply failure

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

Class II — Potential Health HazardTerminated
January 10, 2012· Vital Scientific N.V.

Recalled Item: Selectra ProM Analyzer

The Issue: The action was initiated due power supply failure

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

Class II — Potential Health HazardTerminated
January 10, 2012· Vital Scientific N.V.

Recalled Item: Viva-E

The Issue: The action was initiated due power supply failure

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

Class II — Potential Health HazardTerminated
January 9, 2012· The Anspach Effort, Inc.

Recalled Item: "***Electric Systems Foot Control with Direction Only***Rx Only***" Product...

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
January 9, 2012· The Anspach Effort, Inc.

Recalled Item: "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and...

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
January 9, 2012· The Anspach Effort, Inc.

Recalled Item: "***Electric Systems Foot Control with Direction and Irrigation***Rx...

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
January 6, 2012· Synthes, Inc.

Recalled Item: Hemostatic Bone Putty

The Issue: Revision A of the Hemostatic Bone Putty Brochure

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

Class II — Potential Health HazardTerminated
January 5, 2012· Cook Ireland Ltd.

Recalled Item: Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent

The Issue: Cook Ireland received a product complaint from Japan

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

Class II — Potential Health HazardTerminated
January 4, 2012· GE Healthcare, LLC

Recalled Item: GE Healthcare Muse v7 cardiology information system. Model number 2026443-001:

The Issue: GE Healthcare conducted a recall on the Muse

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

Class II — Potential Health HazardTerminated
December 30, 2011· SpineFrontier, Inc.

Recalled Item: KRD1 PedFuse Rods

The Issue: One of the rods in each of two

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

Class II — Potential Health HazardTerminated
December 29, 2011· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics

The Issue: Stryker Orthopaedics has become aware of the potential

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

Class II — Potential Health HazardTerminated
December 29, 2011· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics...

The Issue: Stryker Orthopaedics has become aware of the potential

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

Class II — Potential Health HazardTerminated
December 23, 2011· SpineFrontier, Inc.

Recalled Item: SpineFrontier S-Lift Lock Shaft Inserter

The Issue: It has been verified through field use that

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

Class II — Potential Health HazardTerminated
December 22, 2011· Church & Dwight Inc

Recalled Item: Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered

The Issue: Church and Dwight plans to take actions to

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

Class II — Potential Health HazardTerminated
December 22, 2011· Church & Dwight Inc

Recalled Item: Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in

The Issue: Church and Dwight plans to take actions to

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

Class II — Potential Health HazardTerminated