Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Premier Guard Drape Recalled by Covidien LLC Due to Sterility compromised due to breach in sterile barrier

Date: January 23, 2017
Company: Covidien LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.

Affected Products

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

Quantity: 42,750 units

Why Was This Recalled?

Sterility compromised due to breach in sterile barrier

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Covidien LLC

Covidien LLC has 248 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report