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 21281–21300 of 38,428 recalls
Recalled Item: ARROW JACC with Chlorag+ard Technology
The Issue: Product sterility may be compromised due to unsealed
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: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Catheterization Kit
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Echogenic Introducer Needle
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clear Fenestrated Drape with Adhesive
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R)
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW PICC Set
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow PICC with Chlorag+ard Technology
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter Hemostasis Valve For use with .038" (.096 cm) dia.
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis...
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.2 Micron Flat Epidural Filter
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.