Agency classClass IIOur severity:High FDA (Devices)·Z-0001-2021·Announced 2020-10-07

Endo GIA Stapler Loading Units Recalled for Staple Formation Defects

FDA recalls Endo GIA Auto Suture Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inadequate hemostasis) in a high-risk medical context without reported injuries or illnesses in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Gray Universal Articulating Loading Units, Item Code 030450, manufactured by Covidien, LP. The recall involves 900,007 units distributed worldwide, including nationwide distribution in the United States.

The recall was initiated because the device staples may not properly form upon application. This assembly error can result in incomplete staple formation, which may prevent adequate hemostasis (stopping of bleeding) during surgical procedures. The product is used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

Healthcare facilities and distributors should stop using the affected units and contact the recalling firm for instructions on return or replacement. The specific lot numbers affected are T0A108X, T7H003X, T8D008X, T8K108X, T9G060X, T0E051X, T7L023X, T8H047X, T8M079X, T7G003X, T8D007X, T8K047X, and T9F132X.

The recalled product

Product: Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Stapler
Hazard: incomplete-staple-formation
inadequate-hemostasis
Affected units: 900,007

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Covidien, LP

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Same hazard · incomplete staple formation