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 24021–24040 of 38,428 recalls

May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreather Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Masks Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreathing Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Masks Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreather Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Masks

The Issue: Reports of tubing detaching from oxygen masks either

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreather Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing Recalled by ConvaTec, Inc...

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Pediatric Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Rebreathing Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreather Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Rebreather Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Masks Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Non-Rebreathing Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· Zimmer Biomet Spine Inc.

Recalled Item: Vitality Spinal Fixation System

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
May 9, 2017· Beckman Coulter Inc.

Recalled Item: Access System-GI Monitor (CA19-9)

The Issue: The Access immunoassays are susceptible to biotin interference

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

Class II — Potential Health HazardTerminated
May 9, 2017· Beckman Coulter Inc.

Recalled Item: Access Thyroglobulin

The Issue: The Access immunoassays are susceptible to biotin interference

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

Class II — Potential Health HazardTerminated