FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Recall number
- Z-0834-2024
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Status
- Open, Classified
- Initiated
- 2023-12-11
- Posted
- 2024-01-26
- Terminated
- not on file
- Reason
- There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
- Root cause
- Under Investigation by firm
- Action
- On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.
- Quantity
- 22,616 (US), 4,476 (OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
- Lot, serial or model codes
- UDI-DI 10705036014928 Lots 442C02 and 442C03
- 510(k) numbers
- ["K163454"]
- 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