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 36861–36880 of 38,428 recalls

October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 24, 2012· Superstat Corp

Recalled Item: Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget

The Issue: The recall was initiated because Superstat Corporation has

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

Class II — Potential Health HazardTerminated
October 23, 2012· Siemens Medical Solutions USA, Inc.

Recalled Item: The Siemens Symbia T series is intended to aid in detecting

The Issue: There is a potential for the linear bearing

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

Class II — Potential Health HazardTerminated
October 23, 2012· Siemens Medical Solutions USA, Inc.

Recalled Item: The Siemens Symbia S series is intended to aid in detecting

The Issue: There is a potential for the linear bearing

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

Class II — Potential Health HazardTerminated
October 23, 2012· Stryker Howmedica Osteonics Corp.

Recalled Item: Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem

The Issue: Stryker has received a report that single size

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

Class II — Potential Health HazardTerminated
October 22, 2012· Alere San Diego, Inc.

Recalled Item: Alere Cholestech LDX Calibration Verification

The Issue: Out of range (increased) HDL Cholesterol results

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

Class III — Low RiskTerminated
October 22, 2012· Alere San Diego, Inc.

Recalled Item: Alere Cholestech LDX Multianalyte Control

The Issue: Out of range (increased) HDL Cholesterol results

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

Class III — Low RiskTerminated
October 22, 2012· Becton Dickinson & Co.

Recalled Item: BD BBL Taxo XV Factor Strips

The Issue: In vitro diagnostic test kit was not manufactured

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

Class II — Potential Health HazardTerminated
October 19, 2012· TITAN SPINE, LLC

Recalled Item: Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard...

The Issue: Titan Spine LLC, is conducting a recall on

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

Class II — Potential Health HazardTerminated
October 19, 2012· Innovative Magnetic Resonance Imaging Systems Inc.

Recalled Item: IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00)

The Issue: IMRIS Inc. initiated a recall of their OR

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

Class II — Potential Health HazardTerminated