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.

38,428 total recalls
0 this month

Showing 21301–21320 of 38,428 recalls

April 11, 2018· Arrow International Inc

Recalled Item: Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG)

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

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.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

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.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Double-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.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Echogenic Needle

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Spring Wire Guide Introducer Needle

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: VPS TipTracker Stylet Accessory

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: ARROWg+ard Blue(R) Central Venous Catheterization Kit

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Continuous Nerve Block Needle

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: SnapLock" Catheter/Syringe Adapter

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: 10 cc Luer-Slip Loss of Resistance Syringe

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

Recalled Item: Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue...

The Issue: Product sterility may be compromised due to unsealed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
April 11, 2018· Arrow International Inc

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.

Class II — Potential Health HazardTerminated