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.
What this means for you
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 lead to inadequate hemostasis (bleeding) during surgery. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Endo GIA Auto Suture Universal Articulating Loading Units (Item Code 030451) manufactured by Covidien, LP. The recall involves 900,007 units that were distributed worldwide, including nationwide in the United States. These devices are used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and the creation of anastomosis.
The recall is due to a potential 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.
Healthcare providers and facilities that have received these specific loading units should stop using them and contact the manufacturer or the FDA for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - 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
- 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 →Related recalls
Same manufacturer · Covidien, LP
See all →- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · incomplete staple formation
See all →- SevereFDA Recalls Covidien TA Auto Suture Vascular Loading Units
FDA (Devices) · 2021-01-06
- SevereFDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components
FDA (Devices) · 2021-01-06
- HighEndo GIA Auto Suture Universal Loading Unit Recall for Staple Formation Defect
FDA (Devices) · 2020-10-07
- HighRecall of Covidien Endo GIA Universal Loading Units Due to Staple Formation Defect
FDA (Devices) · 2020-10-07
- SevereFDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects
FDA (Devices) · 2020-10-07