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 24641–24660 of 38,428 recalls

March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Cataract Kit - Dr. Slingsby

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Minor Operation Kit

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Cataract Kit

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Eye Cataract Pack

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Custom Tray

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Eye Pack

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Plastic Pack

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Ortho Basic Pack

The Issue: AMS custom kits containing Medtronic Covidien Curity Eye

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

Class II — Potential Health HazardTerminated
March 16, 2017· Becton Dickinson & Company

Recalled Item: BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes

The Issue: BD is initiating this product correction of multiple

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

Class II — Potential Health HazardTerminated
March 16, 2017· Zimmer Biomet Spine, Inc

Recalled Item: Altius M-INI OCT Posterior Spinal Fixation System

The Issue: Zimmer Biomet is recalling the Altius M-INI OCT

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

Class II — Potential Health HazardTerminated
March 15, 2017· King Systems Corp. dba Ambu, Inc.

Recalled Item: UNIVERSAL FLEX2 BREATHING CIRCUIT

The Issue: for leak test failures

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

Class II — Potential Health HazardTerminated
March 15, 2017· Toshiba American Medical Systems Inc

Recalled Item: Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model:

The Issue: The issue was identified as a firmware problem

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

Class II — Potential Health HazardTerminated
March 15, 2017· Richard-Allan Scientific Company

Recalled Item: Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid

The Issue: Methylene Blue, Solution #3 in the Kwik Diff

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated
March 15, 2017· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number:

The Issue: for the cutting blade to detach from

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

Class II — Potential Health HazardTerminated