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 37861–37880 of 38,428 recalls

April 17, 2012· ICU Medical, Inc.

Recalled Item: Cardiac Catheterization Waste Management System w/1000mL Waste Bag

The Issue: The firm initiated the recall due to a

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

Class II — Potential Health HazardTerminated
April 16, 2012· Invacare Corporation

Recalled Item: Tracer IV wheelchairs

The Issue: The wheels on Tracer IV wheelchairs (Tracer IV

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

Class II — Potential Health HazardTerminated
April 16, 2012· Berchtold Corp.

Recalled Item: OPERON D850 Surgical Table Product Usage: Surgical Table

The Issue: Table was not lowering

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

Class II — Potential Health HazardTerminated
April 13, 2012· Maquet Medical Systems, Usa

Recalled Item: Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top

The Issue: As a result of a small number of

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

Class II — Potential Health HazardTerminated
April 12, 2012· Varian Medical Systems, Inc.

Recalled Item: Rectal Retractors

The Issue: A medical device used in brachytherapy may become

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

Class II — Potential Health HazardTerminated
April 12, 2012· Varian Medical Systems, Inc.

Recalled Item: Rectal Retractors

The Issue: A medical device used in brachytherapy may become

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

Class II — Potential Health HazardTerminated
April 12, 2012· Becton Dickinson & Co.

Recalled Item: BD Gram Stain Kit

The Issue: for increase level of artifacts to appear

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

Class II — Potential Health HazardTerminated
April 12, 2012· Becton Dickinson & Co.

Recalled Item: Gram Crystal Violet 250 mL

The Issue: for increase level of artifacts to appear

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

Class II — Potential Health HazardTerminated
April 11, 2012· Siemens Medical Solutions USA, Inc.

Recalled Item: E.CAM emission computed tomography system used to detect or image

The Issue: Radial motor drives replaced during a customer service

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

Class II — Potential Health HazardTerminated
April 11, 2012· Siemens Medical Solutions USA, Inc.

Recalled Item: Symbia E is a multi-purpose SPECT system used to detect

The Issue: Radial motor drives replaced during a customer service

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

Class II — Potential Health HazardTerminated
April 11, 2012· Beckman Coulter Inc.

Recalled Item: AutoMate 1250 and AutoMate 2550

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
April 10, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED...

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
April 10, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED...

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
April 10, 2012· Kerr Corporation

Recalled Item: The brand name of the device is Laser Loupes

The Issue: The firm initiated the recall for Laser Loupes

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

Class II — Potential Health HazardTerminated
April 10, 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 I — Serious Health HazardTerminated
April 9, 2012· Linvatec Corp. dba ConMed Linvatec

Recalled Item: "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC...

The Issue: ConMed Linvatec is recalling the product due to

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

Class II — Potential Health HazardTerminated
April 9, 2012· Gulf Fiberoptics, Inc.

Recalled Item: GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65...

The Issue: The GMF-RC65 Replacement Surgical Headlight Cable for Cogent

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

Class II — Potential Health HazardTerminated
April 6, 2012· Steris Corporation

Recalled Item: STERIS 5085 and 5085 SRT Surgical Tables

The Issue: STERIS has learned from Customer feedback and field

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

Class II — Potential Health HazardTerminated
April 6, 2012· Etac Supply Center Ab

Recalled Item: Etac¿ Ono Walker

The Issue: The recall has been initiated because there is

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

Class II — Potential Health HazardTerminated
April 6, 2012· Invacare Corporation

Recalled Item: TDX SP Power Wheelchair

The Issue: Invacare Corporation decided to recall the product because

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

Class II — Potential Health HazardTerminated