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 21721–21740 of 38,428 recalls

February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Zipper Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Zipper Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Pullover Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Sofradim Production

Recalled Item: Versatex Monofilament Mesh 50 x 50cm

The Issue: There have been patient reports of abdominal hernia

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Pullover Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Pullover Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T4 Pullover Toga

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: T5 Zipper Toga with Peel-Away Face Shield

The Issue: Separation of material layers may occur, causing a

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

Class II — Potential Health HazardTerminated
February 23, 2018· Orthofix, Inc

Recalled Item: ORTHOFIX

The Issue: Orthofix is conducting a voluntary recall of the

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

Class II — Potential Health HazardTerminated
February 23, 2018· Orthofix, Inc

Recalled Item: ORTHOFIX

The Issue: Orthofix is conducting a voluntary recall of the

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

Class II — Potential Health HazardTerminated
February 23, 2018· GE Healthcare

Recalled Item: GE Healthcare Centricity PACS-IW

The Issue: A database handling error could occur during the

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

Class II — Potential Health HazardTerminated
February 23, 2018· Deerfield Imaging, Inc.

Recalled Item: IMRIS ORT300

The Issue: The Operating Room Table may drift while in

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

Class II — Potential Health HazardTerminated
February 23, 2018· ConMed Corporation

Recalled Item: MINI INFANT < 3KG

The Issue: Wire sets of certain devices were assembled with

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

Class II — Potential Health HazardTerminated
February 23, 2018· Deerfield Imaging, Inc.

Recalled Item: IMRIS ORT200

The Issue: The Operating Room Table may drift while in

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

Class II — Potential Health HazardTerminated
February 23, 2018· Deerfield Imaging, Inc.

Recalled Item: IMRIS ORT200 Removable Operating Room Table

The Issue: The rotational locking mechanisms on the ORT 200/300

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

Class II — Potential Health HazardTerminated
February 23, 2018· ConMed Corporation

Recalled Item: MINI INFANT < 3KG

The Issue: Wire sets of certain devices were assembled with

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

Class II — Potential Health HazardTerminated
February 23, 2018· Deerfield Imaging, Inc.

Recalled Item: IMRIS T2X Table

The Issue: The Operating Room Table may drift while in

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

Class II — Potential Health HazardTerminated
February 23, 2018· ConMed Corporation

Recalled Item: MINI INFANT < 3KG

The Issue: Wire sets of certain devices were assembled with

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

Class II — Potential Health HazardTerminated
February 23, 2018· ConMed Corporation

Recalled Item: MINI INFANT < 3KG

The Issue: Wire sets of certain devices were assembled with

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

Class II — Potential Health HazardTerminated
February 23, 2018· Deerfield Imaging, Inc.

Recalled Item: IMRIS ORT100 Table

The Issue: The Operating Room Table may drift while in

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

Class II — Potential Health HazardTerminated