Class II — Potential Health Hazard

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

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - Recalled by COVIDIEN MEDTRONIC Due to Device may be missing a sled component. The...

Date: April 26, 2018
Company: COVIDIEN MEDTRONIC
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 MEDTRONIC directly.

Affected Products

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Quantity: 171,271 units in total

Why Was This Recalled?

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About COVIDIEN MEDTRONIC

COVIDIEN MEDTRONIC has 55 total recalls tracked by RecallDetector.

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