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.
Showing 31801–31820 of 38,428 recalls
Recalled Item: EPIQ 7 Ultrasound System
The Issue: When using the QLAB Auto 2D Quantification (a2DQ)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ 5 Ultrasound System
The Issue: When using the QLAB Auto 2D Quantification (a2DQ)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps
The Issue: When using the QLAB Auto 2D Quantification (a2DQ)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyflux Revaclear Max Dialyzer
The Issue: Gambro is initiating a field action for Polyflux
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyflux Revaclear Dialyzer
The Issue: Gambro is initiating a field action for Polyflux
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The
The Issue: problem with the cardiac function analysis software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The
The Issue: problem with the cardiac function analysis software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pulsiocath PiCCO ProAQT Monitoring Kit
The Issue: Internal testing and investigation of the packaging revealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD NX
The Issue: Advanced Sterilization Products is recalling the STERRAD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris
The Issue: A software anomaly was identified where the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris
The Issue: A software anomaly was identified where the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 200
The Issue: Advanced Sterilization Products is recalling the STERRAD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100S
The Issue: Advanced Sterilization Products is recalling the STERRAD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb Stellaris PC w/ Laser
The Issue: A software anomaly was identified where the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100NX
The Issue: Advanced Sterilization Products is recalling the STERRAD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 50
The Issue: Advanced Sterilization Products is recalling the STERRAD System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT
The Issue: The stem taper on this device is undersized;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets
The Issue: Tubing may detach at the connect/disconnect location on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT
The Issue: The stem taper on this device is undersized;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT
The Issue: The stem taper on this device is undersized;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.