FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery Inc: Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Recall number
- Z-2174-2017
- Recalling firm
- Ethicon Endo-Surgery Inc
- Product
- Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Status
- Terminated
- Initiated
- 2017-03-31
- Posted
- not on file
- Terminated
- 2018-05-03
- Reason
- There is a risk that the pinion gear in the device could fail under extreme use cases.
- Root cause
- Process control
- Action
- Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
- Quantity
- 792 units
- Distribution
- Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
- Lot, serial or model codes
- N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
- 510(k) numbers
- ["K111111"]
- 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