FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: Endopath EZ45 Endoscopic Linear Cutter (EZ45B)
- Recall number
- Z-0457-05
- Recalling firm
- Ethicon Endo-Surgery
- Product
- Endopath EZ45 Endoscopic Linear Cutter (EZ45B)
- Status
- Terminated
- Initiated
- 2004-11-21
- Posted
- 2005-02-01
- Terminated
- 2008-10-29
- Reason
- The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
- Root cause
- Other
- Action
- The firm sent letters, dated 11/21/04, to all consignees.
- Quantity
- 3179 devices.
- Distribution
- The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.
- Lot, serial or model codes
- EZ45B: lots T4XE79, T4XF7F, V40043, V40378, V40379, V4080M, V4083P, V40C1U, V40H0Y, V40K5V, V40W6T, V40X9X, V41831, V4197Y, V41A4M, V41C3Z, V41C98, V41E71, V41F9Y, V41U9F, V41Y80, V42105, V42220, V4231R, V4262Z, V4270F, V42C7P, V42G1X, V42K0X, V42MOT, V42P6P, V42V2R, V42Y1J, V42Z8Z, V43231, V43521, V4ZE36, V4ZE39, V4ZJ35, V4ZK34, V4ZV7W, V4ZX2N.
- 510(k) numbers
- ["K020779"]
- PMA numbers
- not on file
- Product code
- GDW
- 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