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 23361–23380 of 38,428 recalls

June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Instrument Set EM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Suction 9734308 Small AxiEM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Curved Suction 90 9733451 EM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Set Supplemental INS AxiEM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Instrument Kit 9733908 Fusion ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Curved Suction 70 9733450 EM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Medtronic Navigation, Inc.

Recalled Item: Medtronic Straight Suction 9733449 EM ENT

The Issue: The instruments are not able to pass instrument

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

Class II — Potential Health HazardTerminated
June 29, 2017· Boston Scientific Corporation

Recalled Item: SQ-RX 1010 Pulse Generator

The Issue: The device can deliver an atypical amount of

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

Class II — Potential Health HazardTerminated
June 29, 2017· Boston Scientific Corporation

Recalled Item: EMBLEM MRI S-ICD Model 219

The Issue: The device can deliver an atypical amount of

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

Class II — Potential Health HazardTerminated
June 29, 2017· Boston Scientific Corporation

Recalled Item: EMBLEM S-ICD

The Issue: The device can deliver an atypical amount of

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: NON-STERILE SAMPLE

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: SORIN GROUP

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated
June 29, 2017· Sorin Group USA, Inc.

Recalled Item: NON-STERILE SAMPLE

The Issue: Medtronic informed LivaNova that some of their DLP

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

Class II — Potential Health HazardTerminated