Agency classClass IIOur severity:High FDA (Devices)·Z-0006-2021·Announced 2020-10-07

Endo GIA Auto Suture Universal Articulating Loading Unit Recall

FDA is recalling Endo GIA Auto Suture Universal Articulating 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 involves a medical device defect that could prevent adequate hemostasis (bleeding control) during surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Universal Articulating Loading Units, Item Code 030455, manufactured by Covidien, LP. The recall involves 900,007 units distributed worldwide, including across the United States. The product is used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

The recall was initiated because the device staples may not properly form upon application, which can prevent adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and facilities should identify and stop using the affected units. The recall covers specific lot numbers, including T0A019X, T7K037X, T8H021X, and others listed in the official FDA notice. Consumers and patients should contact their healthcare provider if they have had surgery involving these devices to discuss any concerns.

The recalled product

Product: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - 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
hemostasis-failure
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