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 1581–1600 of 38,428 recalls
Recalled Item: WATCHMAN TruSteer Access System
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System SGL
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN FXD Curve Access System Sgl
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System ANT
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System ANT
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight
The Issue: Due to a weld breakage between the pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMax V2-US
The Issue: Low deaeration chamber level at post priming tests
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TherMax Blood Warmer Unit-US
The Issue: Thermax System may be unable to detect the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrisMax V3 control Unit-US
The Issue: Unexpected PrisMax System alarm T0830: Blood Leak Detected,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: One Step Sterile Lancet for Single Use (3 sizes): 06949517008861
The Issue: Due to incorrect/lack of Unique Device Identifier (UDI)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZAP-X Radiosurgery System
The Issue: If the radiosurgery system triggers a proximity error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY
The Issue: Medline Industries, LP is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT
The Issue: Medline Industries, LP is issuing a recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 /
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrosurgical
The Issue: for the ESG-410 Electrosurgical Generator to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Electrosurgical
The Issue: for the ESG-410 Electrosurgical Generator to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G7 Continuous Glucose Monitoring System Product Name:
The Issue: The affected devices are the Dexcom G7 Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom ONE+ Continuous Glucose Monitoring System Product Name:
The Issue: The affected devices are the Dexcom G7 Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G7 Continuous Glucose Monitoring System Product Name:
The Issue: The affected devices are the Dexcom G7 Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom ONE+ Continuous Glucose Monitoring System Product Name:
The Issue: The affected devices are the Dexcom G7 Continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.