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 18681–18700 of 38,428 recalls
Recalled Item: 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits
The Issue: Tray label indicates the kits are packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits
The Issue: Tray label indicates the kits are packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits
The Issue: Tray label indicates the kits are packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enFlow Disposable Cartridge
The Issue: Testing has demonstrated aluminum elution from the enFlow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enFlow Disposable Cartridge with IV Extension Set
The Issue: Testing has demonstrated aluminum elution from the enFlow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo Clinch II Auto Suture Grasper
The Issue: Sterilization method used was not consistent with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Endo Grasp Auto Suture Grasper 5mm The
The Issue: Sterilization method used was not consistent with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedure kits include devices from the affected lots distributed OUS
The Issue: Sterilization method used was not consistent with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Truliant Tibial Fit Tray Cemented SZ 3F / 3T
The Issue: 2.5 Truliant Fit Trays were mismarked as 3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits
The Issue: Tray label indicates the kits are packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS
The Issue: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL
The Issue: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM)
The Issue: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: Users need to be aware when using these
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion FlexArm
The Issue: During manufacturing of an Azurion R2.0 system, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beaver Xstar Slit Knife 2.4 mm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Cardiac Control
The Issue: Customers may observe a decrease in recovered concentration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System
The Issue: One of the software algorithms used to detect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT Elements Software revisions of the RT Elements applications have
The Issue: There is a potential for an incorrect dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUVUE OASYS for ASTIGMATISM brand contact lenses
The Issue: One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.