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 561–580 of 38,428 recalls
Recalled Item: Halyard ORGAN RECOVERY OR PACK
The Issue: Devices are not suitable for organ transplant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard ORGAN RECOVERY OR PACK
The Issue: Devices are not suitable for organ transplant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard MINI PLUS KIT SOUTH
The Issue: Devices are not suitable for organ transplant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEXLOCK Achilles Repair Implant Kits
The Issue: There have been multiple complaints of drill bit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER DxH Diluent
The Issue: Due to specific lots of diluents contributing to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ErgoStar CM 60
The Issue: Multiple complaints were reported in which cracks formed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ErgoStar CM 45
The Issue: Multiple complaints were reported in which cracks formed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction
The Issue: Multiple complaints were reported in which cracks formed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Model Knee Fusion Nail SK
The Issue: The device has been delivered with a preassembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ErgoStar CM 55
The Issue: Multiple complaints were reported in which cracks formed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci Product Name: da Vinci X
The Issue: Due to a software implementation error that allowed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 12Fg Seldinger Catheter with
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket Product Name: Rocket 18Fg Seldinger Catheter with
The Issue: IFU and device kit labeling contains misleading statements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Reaction Vessels
The Issue: It has been determined that certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The
The Issue: Due to a number of modules flashed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
The Issue: Following a component change in the DPOAE probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.