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 20641–20660 of 38,428 recalls

June 21, 2018· Degania Silicone, Ltd.

Recalled Item: 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 Sensor 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: 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 Foley 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 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: Foley 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: Temperature sensing 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 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 Catheter with temperature sensor 400TM 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 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: 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: Foley Catheter with temperature sensor 400TM 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: Foley Temperature Sensor 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: Foley Catheter with temperature sensor 400TM 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· Becton Dickinson & Co.

Recalled Item: BD BBL GC-Lect Agar

The Issue: A portion of this lot was manufactured using

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

Class II — Potential Health HazardTerminated
June 21, 2018· DePuy Orthopaedics, Inc.

Recalled Item: CORAIL Cementless Femoral Stem HA Coated Standard Size 11

The Issue: Two lots of femoral stems were labeled as

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

Class II — Potential Health HazardTerminated
June 21, 2018· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Percepta CRT-P MRI SureScan

The Issue: for a device reset to occur in

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

Class II — Potential Health HazardTerminated
June 21, 2018· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Percepta Quad CRT-P MRI SureScan

The Issue: for a device reset to occur in

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

Class II — Potential Health HazardTerminated
June 21, 2018· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Percepta Quad CRT-P MRI SureScan

The Issue: for a device reset to occur in

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

Class II — Potential Health HazardTerminated