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 16741–16760 of 38,428 recalls
Recalled Item: Prismaflex Control Unit
The Issue: Communication error alarms may result in interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit
The Issue: Communication error alarms may result in interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit
The Issue: Communication error alarms may result in interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit
The Issue: Communication error alarms may result in interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis MAXI LD PTA Dilatation Catheter
The Issue: Product was manufactured utilizing an expired inner body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart XL+ Defibrillator/Monitor
The Issue: Device may fail to turn on or unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted
The Issue: Boxes of the 6-Petal X-Change Wall Mesh Small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardia Access Nano Embryo Transfer Catheter is use for transferring
The Issue: Bent transfer catheter tips may cause difficulty or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardia Access Embryo Transfer Catheter is used for transferring IVF
The Issue: Bent transfer catheter tips may cause difficulty or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Level Output Cable Interface to Philips Monitor For Use
The Issue: One lot of "Low Level Output Cable -
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft
The Issue: The staplers may contain an out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft
The Issue: The staplers may contain an out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
The Issue: There is a potential for Medtronic programmer and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
The Issue: There is a potential for Medtronic programmer and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft
The Issue: The staplers may contain an out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft
The Issue: The staplers may contain an out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
The Issue: There is a potential for Medtronic programmer and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Component for Laser Scanning Microscopes (LSM 700
The Issue: When the user tilts the transmitted light arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea TLIF-B Holder
The Issue: Inner draw rod, which threads into the cage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Starburst Talon Semi-Flex Electrosurgical Device
The Issue: The devices are not labelled correctly. End users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.