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 16861–16880 of 38,428 recalls
Recalled Item: Synapse System 3.5mm TI Cancellous Polyaxial Screws
The Issue: The subject product measures 4.0mm in diameter instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Infinity Acute Care System (IACS) Monitoring Solution with the
The Issue: Cybersecurity vulnerabilities may cause device to reboot, lose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODAN SWAN-LOCK Swabable Needlefree Connector
The Issue: Individual packages of connectors may have incomplete or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Sheath Introducer Kit - Product Usage: intended
The Issue: labeling error: Due to a manufacturing issue, product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: diff. in the length of the sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: diff. in the length of the sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System -
The Issue: Berkeley Disposa-Filter may possess an insufficient ultrasonic weld
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cerelink ICP Monitor
The Issue: There is a potential for a progressive decline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microsurgical Operating Room Tables
The Issue: Unintended tilting of the Tabletop MST 7300BX and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microsurgical Operating Room Tables
The Issue: Unintended tilting of the Tabletop MST 7300BX and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Transducer (M1356A)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Loop-Style Tocotransducer (Nautilus) 2264LAX
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toco MP Transducer (M2734B)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Button-Style Ultrasound Transducer (Nautilus)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics V60 Ventilator
The Issue: Ventilator touchscreen may become frozen and fail to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toco M2734A
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Loop-Style Ultrasound Transducer (Nautilus)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics RP-Touch Screen
The Issue: Ventilator touchscreen may become frozen and fail to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External Toco Transducer (M1355A)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics RP-UI Assy
The Issue: Ventilator touchscreen may become frozen and fail to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.