Class II — Potential Health Hazard

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

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection Recalled by COVIDIEN LLC Due to Potential for the sterile barrier to be compromised....

Date: January 17, 2020
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

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

Quantity: 2,180 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About COVIDIEN LLC

COVIDIEN LLC has 22 total recalls tracked by RecallDetector.

Related Recalls

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