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 24621–24640 of 38,428 recalls
Recalled Item: ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM)
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue...
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology
The Issue: When the Smart Check tool is used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tapered SwissPlus Implant System
The Issue: It was manufactured with the minor diameter of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation
The Issue: Medtronic received reports that the DBS depth stop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIZA Vertebral Body Replacement
The Issue: Complaints that implants have been disassembled by surgeons
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous...
The Issue: Arrow International is recalling due to possible voids
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD¿ Administration Set
The Issue: Smiths Medical has become aware that the drawing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Estradiol II
The Issue: Fulvestrant cross reacts with the VIDAS Estradiol II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cataract Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dicken Eye Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRK Tray
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitrectomy Kit
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ophthalmic Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dr. Wischmeier Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitrectomy Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Setup Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lasik Tray
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENT Pack
The Issue: AMS custom kits containing Medtronic Covidien Curity Eye
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.