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 14881–14900 of 38,428 recalls

June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology

The Issue: The needle surface deteriorated due to unexpected electrolysis

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

Class II — Potential Health HazardTerminated
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Percepta CRT-P MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: CareLink SmartSync Device Manager

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Azure S DR MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Cardinal Health 200, LLC

Recalled Item: Cardinal Health NPWT Canister with Gel 300cc

The Issue: Canisters potentially contain an oversized O-ring that cannot

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

Class II — Potential Health HazardTerminated
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Azure XT DR MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Azure S SR MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Azure XT SR MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Patient Connector

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Serena CRT-P MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Solara CRT-P MRI

The Issue: There is a rare communication sequence during the

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

Class II — Potential Health HazardOngoing
June 4, 2020· Cardinal Health 200, LLC

Recalled Item: Cardinal Health NPWT Occlusion Detection Canister 300cc

The Issue: Canisters potentially contain an oversized O-ring that cannot

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

Class II — Potential Health HazardTerminated