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 15221–15240 of 38,428 recalls

April 17, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Cios Alpha Image-Intensified Fluoroscopic X-Ray System

The Issue: The unplugging of the main cable on the

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 183742 Vanguard Knee System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Becton Dickinson & Company

Recalled Item: BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553)

The Issue: This product has been confirmed to exhibit holes

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell

The Issue: The Stryker Restoration Anatomic Shell (RAS) may fall

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

Class II — Potential Health HazardTerminated
April 16, 2020· Elekta Inc

Recalled Item: Elekta MONACO RTP Sytem

The Issue: The Monaco RTP Radiation Treatment Planning System may

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

Class II — Potential Health HazardOngoing