Class II — Potential Health Hazard

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

ASC (Breast) Kit Recalled by Covidien LLC Due to Devon Light Gloves contain splits or holes compromising...

Date: April 16, 2015
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

ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

Quantity: 4,136 kits

Why Was This Recalled?

Devon Light Gloves contain splits or holes compromising the sterility

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