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 25061–25080 of 38,428 recalls

January 12, 2017· Boston Scientific Corporation

Recalled Item: Boston Scientific

The Issue: There is a potential for radio frequency (RF)

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

Class II — Potential Health HazardTerminated
January 11, 2017· Ortho Kinematics, Inc

Recalled Item: Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a

The Issue: Ortho Kinematics Inc. sent a Notice of Correction

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

Class II — Potential Health HazardOngoing
January 11, 2017· Kiscomedica S.A.

Recalled Item: L-Varlock Cage/Trial Implant Holder

The Issue: Firm received a complaint of the tip holder

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Open Procedure Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Nasal Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Ortho Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Upper Torso Tray

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: General Surgery Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Minor/General/Ortho Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Surgical Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Major Pack (1345)

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Orbitofacial Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Knee Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Transvaginal Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Major Kit

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Total Hip Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Laparotomy Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Laparoscopy Pack (1184)

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: Vascular Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated
January 11, 2017· Windstone Medical Packaging, Inc.

Recalled Item: HSG Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of

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

Class II — Potential Health HazardTerminated