FDA Medical Device Recalls (openFDA)
Covidien LLC: SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Recall number
- Z-1833-2019
- Recalling firm
- Covidien LLC
- Product
- SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Status
- Open, Classified
- Initiated
- 2019-05-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- Root cause
- Process control
- Action
- All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
- Quantity
- 3,113,280
- Distribution
- Nationwide domestic distribution, worldwide foreign distribution.
- Lot, serial or model codes
- N6E0176UX N6E0278UX N6E0584UX N6E0587UX N6E0589UX N6E0590UX N6E0975UX N6F0141UX N6F0142UX N6F0143UX N6F0144UX N6F0340UX N6F0341UX N6F0342UX N6F0343UX N6F0436UX N6G0033UX N6G0034UX N6G0035UX N6G0036UX N6G0037UX N6G0038UX N6G0125UX N6G0744UX N6H0757UX N6J0436UX N6K0010UX N6K0372UX N6K0415UX N6K0990UX N6K0991UX N6K1110UX N7C0111X N7C0381X N7C0499X N7C0611X N7D0303X
- 510(k) numbers
- ["K111825","K160176"]
- 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