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 38021–38040 of 38,428 recalls

December 22, 2011· Church & Dwight Inc

Recalled Item: Arm and Hammer Spinbrush Pro Clean Sonic Recharge 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
December 22, 2011· US Endoscopy Group Inc

Recalled Item: Infinity¿ sampling device

The Issue: US Endoscopy received five complaints which noted difficulty

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 Powered Toothbrush Made

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 Crest Powered Toothbrush

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 Dual Action Powered Toothbrush Pro Clean

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 Dual Action Powered Toothbrush Spinbrush Pro

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 Clean Sonic Tray BJS Made

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 Dual Action Powered Toothbrush Pro-Clean

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 ProClean Sonic Recharge Color Wear Made

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· Stryker Howmedica Osteonics Corp.

Recalled Item: Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics

The Issue: Stryker Orthopaedics received a report indicating that a

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

Class II — Potential Health HazardTerminated
December 20, 2011· GE Healthcare, LLC

Recalled Item: GE Healthcare Innova 2100 IQ

The Issue: While performing a fluoroscopic examination on the GE

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

Class II — Potential Health HazardTerminated
December 20, 2011· GE Healthcare, LLC

Recalled Item: GE Healthcare innova 3100-IQ

The Issue: It was discovered of a potential failure of

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

Class II — Potential Health HazardTerminated
December 20, 2011· GE Healthcare, LLC

Recalled Item: GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems

The Issue: It was discovered of a potential failure of

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

Class II — Potential Health HazardTerminated
December 20, 2011· GE Healthcare, LLC

Recalled Item: GE Healthcare innova 3100

The Issue: It was discovered of a potential failure of

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

Class II — Potential Health HazardTerminated
December 19, 2011· Biomet Spine, LLC

Recalled Item: Telluride Percutaneous Rod Inserter Long

The Issue: The Telluride Percutaneous Rod Inserter Long does not

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

Class II — Potential Health HazardTerminated
December 19, 2011· Advanced Neuromodulation Systems Inc.

Recalled Item: The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel

The Issue: As of 11/30/2011, St. Jude Medical has received

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

Class II — Potential Health HazardTerminated
December 19, 2011· Advanced Neuromodulation Systems Inc.

Recalled Item: Eon (Model 3716) IPG is a dual channel

The Issue: As of 11/30/2011, St. Jude Medical has received

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

Class II — Potential Health HazardTerminated
December 19, 2011· Advanced Neuromodulation Systems Inc.

Recalled Item: Eon Mini Neurostimulation (IPG) System (Model 3788)

The Issue: The firm has received 112 complaints of the

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

Class II — Potential Health HazardTerminated
December 15, 2011· Beckman Coulter Inc.

Recalled Item: Synchron Systems Synchron Calibrator Multi Calibrator Diskettes

The Issue: Mislabeling

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

Class III — Low RiskTerminated
December 13, 2011· Beckman Coulter Inc.

Recalled Item: UniCel DxH Slidemaker Stainer Instrument System

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