Agency classClass IIOur severity:Severe FDA (Devices)·Z-0008-2021·Announced 2020-10-07

Endo GIA Stapler Recall Due to Incomplete Staple Formation

FDA recalls Endo GIA Auto Suture staplers 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a surgical device failure that may prevent adequate hemostasis, posing a significant risk of injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Universal Articulating Loading Units (60 mm - 3.5 mm, Item Code 030458) manufactured by Covidien, LP. The recall involves 900,007 units distributed worldwide, including nationwide distribution in the United States.

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

Healthcare providers and facilities that have received these devices should check their inventory against the specific lot numbers listed in the official recall notice. If the affected devices are found, they should be removed from service and returned to the manufacturer or the FDA as directed. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns about their surgical outcome.

The recalled product

Product: Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - 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 Staplers
Hazard: device-malfunction
hemorrhage
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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