FDA Medical Device Recalls (openFDA)
COVIDIEN LLC: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Recall number
- Z-1264-2020
- Recalling firm
- COVIDIEN LLC
- Product
- Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
- Status
- Terminated
- Initiated
- 2020-01-17
- Posted
- not on file
- Terminated
- 2022-07-29
- Reason
- Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
- Root cause
- Package design/selection
- Action
- Medtronic notified consignees by letter via Federal Express and/or certified mail beginning January 17, 2020. The letter informs of the reason for recall, health risk and action to take: Immediately quarantine and discontinue use of the affected itemcode and lot; " Return affected product; Forward the information to anyone who they have distributed. Complete the Recalled Product Return Form even if you do not have inventory. Questions: Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com.
- Quantity
- 2,180 units
- Distribution
- US Nationwide, Israel, and Japan
- Lot, serial or model codes
- Lot Number: P9E0022Y
- 510(k) numbers
- ["K111825"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- 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