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 19101–19120 of 38,428 recalls

December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia 3.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 3.0T TX-series

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 1.5T Conversion

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera IT

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Prodiva CX

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva XR 1.5T/3.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera Achieva 1.5T IT Nova

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 1.5T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia Ambition X

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia Elition S

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 3.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Zimmer Biomet, Inc.

Recalled Item: Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

The Issue: Vanguard Knee System Series-A Standard Patella a potential

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Ingenia Ambition S

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: MR-OR 1.5T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 3.0T for PET

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Panorama 1.0T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 0.5T Standard

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Achieva 1.5T

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Philips Medical Systems Nederlands

Recalled Item: Intera 1.5T High Performance

The Issue: There is a potential for the ceiling speaker(s)

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

Class II — Potential Health HazardTerminated
December 21, 2018· Cook Inc.

Recalled Item: Check-Flo Performer Introducer

The Issue: The products were manufactured with longer than specified

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

Class II — Potential Health HazardTerminated