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 941–960 of 38,428 recalls
Recalled Item: Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience kits
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia circuit kit
The Issue: Firm received multiple complaints of anesthesia circuit leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalyst+ Product Name: Catalyst
The Issue: Due to issues with the system's stereotactic radiosurgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myosa for Kids KS1 /Sp/Mb/Mp/Lb/Lc KS2 /Sc/Mb/Mc/Mp/Lb/Lc Myosa
The Issue: Due to firm mistakenly distributing product within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SJM Pericardial Patch
The Issue: The impacted lot may not meet the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Intersegmental Table
The Issue: The heat function may become damaged over time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SJM Pericardial Patch
The Issue: The impacted lot may not meet the required
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Intersegmental Table
The Issue: The heat function may become damaged over time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog
The Issue: Due to potential corrosion issues associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog
The Issue: Due to potential corrosion issues associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit
The Issue: Due to potential corrosion issues associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Product Name: HeartMate 3 Left Ventricular System
The Issue: Due to potential corrosion issues associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound System 1300
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bk5000 Ultrasound System w/battery
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UUltrasound System 2300
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1202 Flex Focus Ultrasound System
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bk3000 Ultrasound System w/battery
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bk3500 Ultrasound System w/battery
The Issue: GE HealthCare has become aware that the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.