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 37481–37500 of 38,428 recalls

June 27, 2012· KCI USA, Inc.

Recalled Item: RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of

The Issue: The firm is initiating a voluntary medical device

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

Class II — Potential Health HazardTerminated
June 27, 2012· Stryker Medical Division of Stryker Corporation

Recalled Item: Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair

The Issue: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer

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

Class II — Potential Health HazardTerminated
June 27, 2012· Stryker Medical Division of Stryker Corporation

Recalled Item: Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair

The Issue: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer

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

Class II — Potential Health HazardTerminated
June 27, 2012· Stryker Medical Division of Stryker Corporation

Recalled Item: Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair

The Issue: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer

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

Class II — Potential Health HazardTerminated
June 27, 2012· Stryker Medical Division of Stryker Corporation

Recalled Item: Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair

The Issue: Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer

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

Class II — Potential Health HazardTerminated
June 27, 2012· Perkinelmer

Recalled Item: Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product

The Issue: Contamination from GSP Shaker unit results in decreased

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

Class II — Potential Health HazardTerminated
June 27, 2012· Smiths Medical ASD, Inc.

Recalled Item: Smiths Medical HOTLINE 3 Blood and Fluid Warmer

The Issue: HOTLINE 3 Blood and Fluid Warmer( Reorder No

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

Class II — Potential Health HazardTerminated
June 26, 2012· GE Healthcare, LLC

Recalled Item: GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal

The Issue: Disposable T-Piece circuits used with resuscitation systems are

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

Class I — Serious Health HazardTerminated
June 26, 2012· GE Healthcare, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture

The Issue: Linvatec Corporation DBA ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO

The Issue: Linvatec Corporation dba ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***PressFT***2.1 w/ One #2 (5 metric)...

The Issue: Linvatec Corporation dba ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***PressFT***2.6 w/ Two #1 (4 metric)...

The Issue: Linvatec Corporation dba ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***PressFT***2.1 w/ Two #0 (3.5 metric)...

The Issue: Linvatec Corporation dba ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***PressFT***2.6 w/ One #2 (5 metric)...

The Issue: Linvatec Corporation dba ConMed Linvatec in Largo, FL

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

Class II — Potential Health HazardTerminated
June 26, 2012· Sunrise Medical (US) LLC

Recalled Item: Padded Swing Away Arm Rest with Receiver

The Issue: Reports of injury when the Padded Swing Away

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

Class II — Potential Health HazardTerminated
June 26, 2012· Bridgepoint Medical

Recalled Item: BridgePoint Medical

The Issue: BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter,

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

Class II — Potential Health HazardTerminated
June 25, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist

The Issue: safety issue when using the IMMEDIATE RESUMPTION

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

Class II — Potential Health HazardTerminated
June 25, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 220/240V The Terumo Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

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

Class II — Potential Health HazardTerminated
June 25, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 100/120V The Terumo Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

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

Class II — Potential Health HazardTerminated