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 20621–20640 of 38,428 recalls

June 21, 2018· Ossur Americas

Recalled Item: Ossur

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Johnson & Johnson Surgical Vision Inc

Recalled Item: Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC

The Issue: Expired intraocular lenses were distributed

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Foley Catheter with temperature sensor 400TM 16FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensing 100% Silicone Foley Catheter

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature sensor Foley catheter 10FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensor Catheter 16FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature sensing catheter 18FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature sensing catheter 16FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Foley Catheter with temperature sensor 400TM 8FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Foley Temperature Sensor Catheter 12FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensing 100% Silicone Foley Catheter

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Foley Temperature Sensor Catheter 14FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensor Catheter 14FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature sensor Foley catheter 8FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Thermistor Foley catheter

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature sensing catheter 16FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensor Catheter 8FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Thermistor Foley catheter

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated
June 21, 2018· Degania Silicone, Ltd.

Recalled Item: Temperature Sensor Catheter 18FR

The Issue: The catheters are suspected to contain defective sensors;

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

Class II — Potential Health HazardTerminated