FDA Medical Device Recalls (openFDA)
Covidien LLC: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
- Recall number
- Z-0908-2018
- Recalling firm
- Covidien LLC
- Product
- Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
- Status
- Terminated
- Initiated
- 2017-09-15
- Posted
- not on file
- Terminated
- 2018-12-19
- Reason
- The device cartridge disengaged during use due to manufacturing error.
- Root cause
- Process control
- Action
- Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: feedback.customerservice@Covidien.com. For further questions, please call (203) 492-5000.
- Quantity
- 163
- Distribution
- Internationally, including Japan. No USA Customers
- Lot, serial or model codes
- Product number: EGIARADXT Lot code: N6L0351X
- 510(k) numbers
- ["K132493"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28