FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.
- Recall number
- Z-0213-04
- Recalling firm
- Ethicon Endo-Surgery
- Product
- Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.
- Status
- Terminated
- Initiated
- 2003-11-25
- Posted
- 2003-12-17
- Terminated
- 2012-05-09
- Reason
- A defective articulation band may result in improper staple formation with possible hematosis.
- Root cause
- Nonconforming Material/Component
- Action
- The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
- Quantity
- 49,395
- Distribution
- The product was shipped to hospitals and distributors located nationwide and worldwide.
- Lot, serial or model codes
- Lot Numbers: T4VM9R, T4VN0R, T4VNOX, T4VP71, T4VR0U, T4VR3F, T4VR8Z, T4VT68, T4VT75, T4VU1Z, T4VV8U, T4VW33, T4VW34, T4VW7F, T4VW97, T4VX7P, T4VX7R, T4W03T, T4W11A, T4W11X, T4W188, T4W189, T4W31Y, T4W66N, T4W66T, T4W67V, T4W70V, T4W86G, T4W86H, T4W86N, T4WA3R, T4WA6T, T4WA9Z, T4WD68, T4WD6L, T4WD6M, T4WG04, T4WG05, T4WG4K, T4WG6T, T4WG90, T4WH0K, T4WH5J, T4WH5X, T4WH7N, T4WH9G, T4WK6Z, T4WK70, T4WL2U, T4WM6V, T4WN19, T4WN2K, T4WT0F, T4WT0G, T4WU2P, T4WU4L, T4WU5G, T4WU9W, T4WV7E, T4WV8X, T4WX7E, T4WY7P, T4WY7R, T4WZ62, T4X11U, T4X15M, T4X16G, T4X27L, T4X28X, T4X35P, T4X367, T4X46T, T4X46U, T4X631, T4X634, T4X706, T4X707, T4X708, T4X78T, T4X83P, T4X904, T4X905, T4X929, T4XA2Z, T4XA30, T4XC31, T4XE0A, T4XE20, T4XE21, T4XE8Z, T4XE9M, T4XE9N, T4XG9Y, T4XG9Z, T4XH00, T4XH01, T4XK06, T4XK08, T4XK09, T4XM47, T4XM48, T4XM7L, T4XN4Z, T4XN53, T4XN5N, T4XR2N, T4XR2R, T4XT15, T4XU8W, T4XV2K, T4XV2N, T4XW40, T4XW79, T4XZ9L, T4Y01X, T4Y02U, T4Y16K, T4Y16L, T4Y16M, T4Y21N, T4Y21P, T4Y21R, T4Y26W, T4Y26X, T4Y272, T4Y39G, T4Y39L, T4Y634, T4Y635, T4Y636, T4Y75M, T4Y75N, T4Y75P, T4Y75R, T4Y75T, T4YA05, T4YA06, T4YC2K, T4YC2M, T4YC2P.
- 510(k) numbers
- ["K020779","K961390"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- 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