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 34801–34820 of 38,428 recalls

September 10, 2013· Steris Corporation

Recalled Item: VERIFY¿ Dual Species Self-Contained Biological Indicator

The Issue: STERIS has identified that the population of the

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

Class II — Potential Health HazardTerminated
September 10, 2013· Aesculap, Inc.

Recalled Item: Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar

The Issue: Complaints were received for the GN161 Bipolar Foot

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

Class II — Potential Health HazardTerminated
September 10, 2013· Wexford Labs Inc

Recalled Item: Ready to Use Thymo-Cide

The Issue: Expired active ingredient was used in the manufacture

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

Class II — Potential Health HazardTerminated
September 10, 2013· Baxter Healthcare Corp.

Recalled Item: Dual Luer Lock Cap The device is intended for use

The Issue: The firm is recalling lots 10043 and 10044

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

Class II — Potential Health HazardTerminated
September 10, 2013· Integra Limited

Recalled Item: Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring...

The Issue: Integra LifeSciences has identified through an internal evaluation

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

Class II — Potential Health HazardTerminated
September 10, 2013· Smiths Medical ASD, Inc.

Recalled Item: Smith Medical

The Issue: Smiths Medical is conducting a voluntary recall of

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

Class II — Potential Health HazardTerminated
September 10, 2013· Smiths Medical ASD, Inc.

Recalled Item: Smiths Medical

The Issue: Smiths Medical is conducting a voluntary recall of

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

Class II — Potential Health HazardTerminated
September 9, 2013· Hospira Inc.

Recalled Item: *** 1) Product labeled in part: 14951-48

The Issue: Intravenous fluid may leak at the CLAVE secondary

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

Class II — Potential Health HazardTerminated
September 9, 2013· Hospira Inc.

Recalled Item: *** 1) Product labeled in part: List No. 14220-28

The Issue: Intravenous fluid may leak at the CLAVE secondary

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

Class II — Potential Health HazardTerminated
September 9, 2013· Hospira Inc.

Recalled Item: *** 1) Product labeled in part: 19734-28

The Issue: Intravenous fluid may leak at the CLAVE secondary

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

Class II — Potential Health HazardTerminated
September 9, 2013· Hospira Inc.

Recalled Item: *** 1) Product labeled in part: 19683-28

The Issue: Intravenous fluid may leak at the CLAVE secondary

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

Class II — Potential Health HazardTerminated
September 9, 2013· Hospira Inc.

Recalled Item: *** 1) Product labeled in part: List No. 14212-28

The Issue: Intravenous fluid may leak at the CLAVE secondary

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

Class II — Potential Health HazardTerminated
September 9, 2013· Beckman Coulter Inc.

Recalled Item: ISE

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
September 9, 2013· Beckman Coulter Inc.

Recalled Item: ISE

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
September 9, 2013· Becton Dickinson & Co.

Recalled Item: BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube

The Issue: An in-vitro diagnostic reagent may be labeled with

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

Class II — Potential Health HazardTerminated
September 6, 2013· Winco Mfg., LLC

Recalled Item: PREMIER CARE RECLINER 5570 with Urethane armrests

The Issue: A supplier manufacturing assembly defect with the right

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

Class II — Potential Health HazardTerminated
September 6, 2013· Winco Mfg., LLC

Recalled Item: XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard

The Issue: A supplier manufacturing assembly defect with the right

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

Class II — Potential Health HazardTerminated
September 6, 2013· Winco Mfg., LLC

Recalled Item: CONVALESCENT RECLINER 5251/5261

The Issue: A supplier manufacturing assembly defect with the right

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

Class II — Potential Health HazardTerminated
September 6, 2013· Winco Mfg., LLC

Recalled Item: DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms

The Issue: A supplier manufacturing assembly defect with the right

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

Class II — Potential Health HazardTerminated
September 6, 2013· bioMerieux, Inc.

Recalled Item: chromID Salmonella Agar

The Issue: Salmonella Contamination

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

Class II — Potential Health HazardTerminated