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 33961–33980 of 38,428 recalls
Recalled Item: NxStage PureFlow-B Solution
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella BCYE Growth Supplement
The Issue: The product may contain high levels of microbial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable Clip Applier Manufactured by AtriCure
The Issue: The firm was notified by a customer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interfit Shell
The Issue: Inner spherical radius of the shell is undersized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malibu Polyaxial Screwdriver
The Issue: Integra LifeSciences has identified through an investigation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Needleless Connector
The Issue: CareFusion is recalling the SmartSite Needlefree Connector, model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Buzzaround XL scooters' Product Usage: mobility
The Issue: Buzzaround XL scooters' front to rear lockup can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109
The Issue: Dako has initiated a recall of HER2 CISH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P
The Issue: HORIBA Medical is informing all ABX PENTRA MultiCal,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crimper Model 9100CR26 The Crimper is indicated for use in
The Issue: Edwards Lifesciences is recalling two lot numbers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDITECH Microbiology - Calculator/data processing module
The Issue: for patient results being removed from LAB/EMR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal ST. Circumcision Clamp
The Issue: Three lots of circumcision clamps were manufactured out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is
The Issue: Zest Anchors, LLC is voluntarily recalling specific lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trifurcated Extension Set
The Issue: CareFusion is recalling the Trifurcated Extension Set, models
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
The Issue: Ortho Clinical Diagnostics has determined that the VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FOCUS is a microprocessor controlled intra-oral x-ray unit with
The Issue: Instrumentarium Dental has delivered a number of FOCUS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InnerCool RTx Endovascular System
The Issue: Phillips Healthcare initiated this action because the Main
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accuray CyberKnife Robotic Radiosurgery System
The Issue: Safety issue with Synchrony Boom Arm Mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15)
The Issue: Product does not function as intended up to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.