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 37781–37800 of 38,428 recalls
Recalled Item: CIVCO General Purpose Sensor
The Issue: The general purpose electromagnetic sensor was incorrectly calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO General Purpose Sensor
The Issue: The general purpose electromagnetic sensor was incorrectly calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO VirtuTRAX Instrument Navigator
The Issue: The general purpose electromagnetic sensor was incorrectly calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USA-002 Rev A brochure is a two sided tri-fold printed
The Issue: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: US-001 Rev A brochure is a two sided tri-fold printed
The Issue: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance iCT and iCT SP are Computed Tomography X-Ray
The Issue: Philips is issuing a software update (version 3.2.4)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Robotic hand accessory to InMotion Arm
The Issue: Unsupervised patient could potentially mis-use the device and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tabs Professional Monitor
The Issue: The monitor may fail to sound an alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tabs Professional Monitor
The Issue: The monitor may fail to sound an alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tabs Professional Voice + Monitor
The Issue: The monitor may fail to sound an alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tabs Professional Voice + Monitor
The Issue: The monitor may fail to sound an alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tabs Professional Monitor
The Issue: The monitor may fail to sound an alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Scenaria CT System Software Product Usage: The Scenaria system
The Issue: Hitachi discovered a software error in the Reconstruction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safedraw Venous Close Loop System
The Issue: Some of the kits may exhibit a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle
The Issue: Additional Instructions for Use and Surgical Technique for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depuy Spine Side Fire Needles 13G X 6IN
The Issue: Additional Instructions for Use and Surgical Technique for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depuy Spine Side Fire Needles 11G X 4IN
The Issue: Additional Instructions for Use and Surgical Technique for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle
The Issue: Additional Instructions for Use and Surgical Technique for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R)...
The Issue: Lidstock of product does not contain chlorhexidine contraindication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Incu i
The Issue: There is a potential for the device's canopy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.