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 15041–15060 of 38,428 recalls

May 8, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: uCT 530 Computed Tomography X-Ray System

The Issue: Two issues were identified with the computed tomography

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

Class II — Potential Health HazardOngoing
May 8, 2020· Merge Healthcare, Inc.

Recalled Item: Merge Healthcare Merge Application Server Software Release and Merge Healthcare

The Issue: An error in the calculation of the Michigan

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

Class II — Potential Health HazardTerminated
May 8, 2020· Arrow International Inc

Recalled Item: Arrow FlexTip Plus Epidural Kit with NRFit Connector

The Issue: Nine complaints reported that the rotatable collar on

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

Class II — Potential Health HazardOngoing
May 7, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica Solution IM1300 Analyzer

The Issue: Insufficient sample may not be detected when using

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

Class II — Potential Health HazardOngoing
May 7, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica Solution IM1600 Analyzer

The Issue: Insufficient sample may not be detected when using

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

Class II — Potential Health HazardOngoing
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Compression Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker End Cap

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: MAMMOMAT Revelation

The Issue: If an examination is interrupted when the InSpect

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker 1 End Cap T2 Humerus ¿6mm

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker End Cap T2 Humerus ¿6mm

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker Locking Screw

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated
May 7, 2020· Stryker GmbH

Recalled Item: Stryker End Cap

The Issue: Seal integrity of the blister pack may be

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

Class II — Potential Health HazardTerminated