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 361–380 of 38,428 recalls
Recalled Item: Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
The Issue: It was found that the MX40 device could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The
The Issue: corrosion stains on the surface of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number:
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog...
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number:...
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges...
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog...
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges...
The Issue: Customers may experience inaccurate test results by observing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kii Low Profile
The Issue: There is the potential for extended length of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is used for the evaluation of the intrinsic coagulation pathway
The Issue: for microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mazor X robotic guidance system
The Issue: Software errors that can result in incorrect surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System with Particle Therapy License (License Kit
The Issue: Using oncology information system that manages workflow may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a
The Issue: Elevated Laser Output A disconnected cable or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMV DSI
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMV BodyTrack
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMV DSX New Line
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAXXUS
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALACOS Product Name: PALACOS R+G pro 40
The Issue: increase of complaints regarding the breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALACOS Product Name: PALACOS MV pro 40
The Issue: increase of complaints regarding the breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.