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 28041–28060 of 38,428 recalls

January 22, 2016· Covidien LLC

Recalled Item: Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap

The Issue: Aplicare Castile Soap towelettes included in the Foley

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

Class II — Potential Health HazardTerminated
January 22, 2016· Covidien LLC

Recalled Item: Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿

The Issue: Aplicare Castile Soap towelettes included in the Foley

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

Class II — Potential Health HazardTerminated
January 22, 2016· Covidien LLC

Recalled Item: Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile

The Issue: Aplicare Castile Soap towelettes included in the Foley

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

Class II — Potential Health HazardTerminated
January 22, 2016· Covidien LLC

Recalled Item: Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile

The Issue: Aplicare Castile Soap towelettes included in the Foley

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

Class II — Potential Health HazardTerminated
January 22, 2016· Sekisui Diagnostics P.E.I. Inc.

Recalled Item: Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay

The Issue: Crystal formation in the Color Reagent (R2) when

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

Class II — Potential Health HazardTerminated
January 22, 2016· Accuray Incorporated

Recalled Item: CyberKnife Robotic

The Issue: The gun box mounting bracket may fail to

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Covidien LLC

Recalled Item: Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line

The Issue: 8FR 16 PVC tubes were packaged in a

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

Class II — Potential Health HazardTerminated
January 21, 2016· Covidien LLC

Recalled Item: Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line

The Issue: 8FR 16 PVC tubes were packaged in a

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· EKOS Corporation

Recalled Item: EkoSonic Endovascular System

The Issue: The EkoSonic kit, including the individually labeled MicroSonic

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated
January 21, 2016· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker

The Issue: During a review of the packaging, it was

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

Class II — Potential Health HazardTerminated