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 21261–21280 of 38,428 recalls
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: Epidural Needle
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VPS Rhythm ECG Accessory Pack with Johans Adapter
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous...
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: Extension Line Slide Clamps
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)
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Kit with Sharps Safety Features
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery 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: ARROWgard Blue PLUS Triple-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: 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: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Catheter Trimmer
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: VPS Rhythm ECG Accessory Pack
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TheraCath(R) Epidural Catheter
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7Fr. Catheter Clamp with Fastener
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximal Barrier Drape
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single-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: 5Fr. Catheter Clamp with Fastener
The Issue: Product sterility may be compromised due to unsealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.