FDA Medical Device Recalls (openFDA)
Covidien LLC: EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Recall number
- Z-1825-2019
- Recalling firm
- Covidien LLC
- Product
- EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- 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
- lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX
- 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