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 15761–15780 of 38,428 recalls

January 30, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic

The Issue: Medtronic Conexus Telemetry has been determined to contain

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

Class II — Potential Health HazardOngoing
January 30, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program

The Issue: Medtronic Conexus Telemetry has been determined to contain

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

Class II — Potential Health HazardOngoing
January 30, 2020· Organ Recovery Systems, Inc.

Recalled Item: LKT200 Perfusion Circuit

The Issue: Observed leakage at the sample port assembly which

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

Class II — Potential Health HazardTerminated
January 29, 2020· Inova Lasers LLC

Recalled Item: Class IV New Era medical laser device

The Issue: The firm failed to comply with the applicable

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

Class II — Potential Health HazardOngoing
January 29, 2020· Beckman Coulter Inc.

Recalled Item: ISE Electrolyte (2 X 2L) Reagent

The Issue: Electrolyte reference reagent, used for clinical laboratory testing

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

Class II — Potential Health HazardTerminated
January 29, 2020· Fresenius Medical Care Holdings, Inc.

Recalled Item: Honeywell Pressure Transducer- Part Number: 370506-22. It is a component

The Issue: The firm is replacing pressure transducers with an

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

Class II — Potential Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TRAVELER Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TRAVELER Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TRAVELER Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TRAVELER Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TREK Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated
January 29, 2020· Abbott Vascular

Recalled Item: NC TRAVELER Coronary Dilatation Catheter

The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability

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

Class I — Serious Health HazardTerminated