COVIDIEN LLC recalls Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAU…

Recall date

January 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1264-2020

FDA classification

Class II

Brand / firm

COVIDIEN LLC

Sold / distributed

US Nationwide, Israel, and Japan

Why it was recalled

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND