FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Recall number
- Z-0147-2026
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Status
- Open, Classified
- Initiated
- 2025-09-11
- Posted
- 2025-10-14
- Terminated
- not on file
- Reason
- The devices were shipped unsterilized.
- Root cause
- Under Investigation by firm
- Action
- An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification.
- Quantity
- 3 units
- Distribution
- International distribution to the countries of United Arab Emirates.
- Lot, serial or model codes
- UDI-DI: 10705036030881; Lot Number: 904C12
- 510(k) numbers
- ["K223760"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1527736
- Firm city
- Blue Ash
- Firm state
- OH
- 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