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 36681–36700 of 38,428 recalls

November 21, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic

The Issue: The presence of plastic flash was identified at

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

Class II — Potential Health HazardTerminated
November 20, 2012· GE Healthcare It

Recalled Item: Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System

The Issue: The Centricity Laboratory removes free-text notes on a

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

Class II — Potential Health HazardTerminated
November 20, 2012· GE Healthcare It

Recalled Item: The Centricity Laboratory System is intended to be an information

The Issue: GE Healthcare is aware of a potential safety

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

Class III — Low RiskTerminated
November 20, 2012· GE Healthcare It

Recalled Item: The Centricity Laboratory System is intended to be an information

The Issue: If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set

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

Class II — Potential Health HazardTerminated
November 20, 2012· ConMed Corporation

Recalled Item: WANG Transbronchial Aspiration Needles Cat. No. MW-221

The Issue: ConMed received complaints from a user facility reporting

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

Class II — Potential Health HazardTerminated
November 20, 2012· ConMed Corporation

Recalled Item: WANG Transbronchial Aspiration Needles Cat. No. MW-322

The Issue: ConMed received complaints from a user facility reporting

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

Class II — Potential Health HazardTerminated
November 20, 2012· ConMed Corporation

Recalled Item: WANG Transbronchial Aspiration Needles Cat. No. SW-121

The Issue: ConMed received complaints from a user facility reporting

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

Class II — Potential Health HazardTerminated
November 20, 2012· ConMed Corporation

Recalled Item: WANG Transbronchial Aspiration Needles Cat. No. MW-222

The Issue: ConMed received complaints from a user facility reporting

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

Class II — Potential Health HazardTerminated
November 19, 2012· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic Intersept Custom Tubing Pack with or without coating (

The Issue: Medtronic is initiating an Urgent Medical Device Customer

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

Class II — Potential Health HazardTerminated
November 19, 2012· Fisher & Paykel Healthcare, Ltd.

Recalled Item: Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing...

The Issue: FPH has become aware that one batch of

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

Class I — Serious Health HazardTerminated
November 19, 2012· Roche Diagnostics Operations, Inc.

Recalled Item: Roche COBAS INTEGRA 400 and 400 plus Analyzer

The Issue: A software security issue with Oracles TNS-Listener component

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

Class III — Low RiskTerminated
November 19, 2012· Zimmer, Inc.

Recalled Item: COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS

The Issue: Zimmer is initiating a lot specific recall because

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

Class II — Potential Health HazardTerminated
November 19, 2012· BioHorizons Implant Systems Inc

Recalled Item: AutoTac Delivery Handle

The Issue: The cleaning instructions provided may not be sufficient

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

Class II — Potential Health HazardTerminated
November 19, 2012· Zimmer, Inc.

Recalled Item: Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular

The Issue: Zimmer is initiating a lot specific recall because

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

Class II — Potential Health HazardTerminated
November 19, 2012· BioHorizons Implant Systems Inc

Recalled Item: Titanium Tack Starter Kit

The Issue: The cleaning instructions provided may not be sufficient

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

Class II — Potential Health HazardTerminated
November 19, 2012· Bunnell, Inc.

Recalled Item: Patient Circuit used with the Life Pulse High Frequency Ventilator.

The Issue: Customer complaints received indicate the heater wire insulation

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

Class I — Serious Health HazardTerminated
November 16, 2012· Ge Healthcare It

Recalled Item: Centricity Enterprise Archive is a software product for receiving

The Issue: There is a potential for data loss associated

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

Class II — Potential Health HazardTerminated
November 16, 2012· Arjo, Inc. dba ArjoHuntleigh

Recalled Item: Enterprise 8000 Bed

The Issue: ArjoHuntleigh has received reports of unintended movement where

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

Class II — Potential Health HazardTerminated
November 16, 2012· Arjo, Inc. dba ArjoHuntleigh

Recalled Item: Enterprise 9000 Bed

The Issue: ArjoHuntleigh has received reports of unintended movement where

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

Class II — Potential Health HazardTerminated
November 16, 2012· Abbott Laboratories, Inc

Recalled Item: Clinical Chemistry Phenobarbital

The Issue: Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent

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

Class II — Potential Health HazardTerminated