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 24561–24580 of 38,428 recalls
Recalled Item: Dimension Vista Prolactin (PRL) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Estradiol (E2) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Ferritin (FERR) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Troponin 1 (TNI) Flex reagent cartridge
The Issue: The concentrations for Biotin listed in the Non-Interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sample probes associated with: cobas 6000 Series System
The Issue: Due to a design change in 2015, corrosion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: In specific circumstances, the user is able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickFlash Radial Artery/Arterial Line Catheterization Kit 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: ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High...
The Issue: The large-bore two-lumen catheter permits venous access to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable
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 ARROW(R) PICC Kit with Chlorag+ard(R) Technology The...
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R)
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use
The Issue: Arrow International initiated the recall due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally
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 Multi-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: 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 Multi-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.