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 34021–34040 of 38,428 recalls

January 6, 2014· Medtronic Sofamor Danek USA Inc

Recalled Item: Medtronic GRAFTON (R) DBM

The Issue: Product was labeled as being measured as 2.5

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

Class II — Potential Health HazardTerminated
January 6, 2014· Zimmer Dental Inc

Recalled Item: Tapered Screw-Vent Implant

The Issue: Zimmer Dental is conducting a voluntary recall of

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

Class II — Potential Health HazardTerminated
January 6, 2014· Boston Scientific Corporation

Recalled Item: Atlantis PV

The Issue: Reports of physicians experiencing inability to pass a

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

Class II — Potential Health HazardTerminated
January 3, 2014· Medtronic Sofamor Danek USA Inc

Recalled Item: SET SCREW RETAINING DRIVER

The Issue: The retaining tabs component of the Set Screw

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

Class II — Potential Health HazardTerminated
January 3, 2014· Davol, Inc., Subs. C. R. Bard, Inc.

Recalled Item: Composix L/P with Echo PS 6" X 8" Product Code

The Issue: Product labeling does not match product configuration

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

Class II — Potential Health HazardTerminated
January 3, 2014· Davol, Inc., Subs. C. R. Bard, Inc.

Recalled Item: Composix L/P with Echo PS 10" X 13" Product Code

The Issue: Product labeling does not match product configuration

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

Class II — Potential Health HazardTerminated
January 1, 2014· Abbott Point Of Care Inc.

Recalled Item: i-STAT G3+ Cartridge pH

The Issue: Abbott Point of Care has determined that some

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

Class II — Potential Health HazardTerminated
December 30, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Neptune 2 Rover Ultra Waste Management System.

The Issue: The purpose of this correction is to upgrade

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

Class II — Potential Health HazardTerminated
December 30, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Neptune 2 Rover Ultra Waste Management System

The Issue: The purpose of this correction is to upgrade

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

Class II — Potential Health HazardTerminated
December 27, 2013· Stryker Medical Division of Stryker Corporation

Recalled Item: The Gaymar Medi-Therm device provides a means of regulating patient

The Issue: Stryker Medical has identified that on some units

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

Class II — Potential Health HazardTerminated
December 27, 2013· GE Healthcare, LLC

Recalled Item: GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The

The Issue: GE Healthcare has recently become aware of potential

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

Class II — Potential Health HazardTerminated
December 26, 2013· Carestream Health, Inc.

Recalled Item: KODAK DirectView DR 7500 Dual Detector System

The Issue: Carestream Health, Inc. has recalled DR 7500 Dual

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

Class II — Potential Health HazardTerminated
December 26, 2013· Vital Signs Colorado Inc.

Recalled Item: Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for

The Issue: A circuit in use was occluded by a

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 5" Smallbore Ext Set w/MicroClave¿ T-Connector

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 7" (18 cm) Appx 0.31 ml

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 5" Smallbore Ext Set w/MicroClave¿ T-Connector

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 78" Ext Set w/2 BCV-Clave¿

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 6" (15 cm) Appx 0.58 ml

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 103" (262 cm) Appx 3.9 ml

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated
December 24, 2013· ICU Medical, Inc.

Recalled Item: 14" (36 cm ) Appx 0.50 ml

The Issue: ICU Medical is recalling certain lots of the

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

Class II — Potential Health HazardTerminated