FDA Medical Device Recalls (openFDA)
Covidien LLC: Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
- Recall number
- Z-0636-2018
- Recalling firm
- Covidien LLC
- Product
- Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
- Status
- Terminated
- Initiated
- 2017-09-13
- Posted
- 2018-02-16
- Terminated
- 2019-06-28
- Reason
- Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
- Root cause
- Under Investigation by firm
- Action
- All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
- Quantity
- 3,816
- Distribution
- Nationally
- Lot, serial or model codes
- N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
- 510(k) numbers
- ["K111825"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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