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 19761–19780 of 38,428 recalls
Recalled Item: Leica M525 F20 Surgical Microscope System
The Issue: The firm received complaints that the instrument tipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dash 5000 Patient Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solar 9500 Information Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solar 8000M Patient Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dash 3000 Patient Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dash 4000 Patient Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solar 8000i Patient Monitoring System is used to monitor physiologic
The Issue: The patient monitors may simultaneously restart as designed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuoSaph Plus Endoscopic Vessel Harvesting System
The Issue: The system's IFU contains a list of generators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Widex BABY hearing aid ( to as BABY440)
The Issue: The reason for this field action is due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ashland(TM) Box Film Ball Cube II EBT3
The Issue: the Ball Cube II phantom calibration film was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Urine Collection Cups
The Issue: BD Vacutainer Urine Collection Cups may contribute to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT URIN CUP 16X100 8.0 CONI UA YEL
The Issue: BD Vacutainer Urine Collection Cups may contribute to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT URIN CUP PLC 16X100 10.0 UA YEL
The Issue: BD Vacutainer Urine Collection Cups may contribute to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Specimen Collection Cups
The Issue: BD Vacutainer Urine Collection Cups may contribute to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AGB + Multi-Lumen CVC Kit
The Issue: The product was shipped after its expiry date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm 1000 2nd Edition Imaging System
The Issue: Software anomalies were reported to affect the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.