Agency classClass IIOur severity:Severe FDA (Devices)·Z-0004-2021·Announced 2020-10-07

FDA Recalls Endo GIA Stapler Loading Units Due to Staple Formation Defect

The FDA is recalling specific lots of 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 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 defect that may prevent adequate hemostasis, posing a significant risk of injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453. The recalling firm is Covidien, LP. The affected products are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.

The recall is due to an assembly error where the device staples may not properly form upon application. This defect can result in incomplete staple formation, which may prevent adequate hemostasis (control of bleeding) during surgical procedures.

A total of 900,007 units are affected by this recall. The products were distributed worldwide, including nationwide in the United States and globally. The specific lot numbers involved are T7F017X, T7J023X, T7L032X, T7L034X, T8L100X, T7F025X, T7J024X, T7L033X, T7L035X, T9F138X, T7F026X, and T7K020X. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected units.

The recalled product

Product: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - 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: 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

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · incomplete staple formation