FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: General Laparoscopic Tray, Product #TGL53.
- Recall number
- Z-0222-04
- Recalling firm
- Ethicon Endo-Surgery
- Product
- General Laparoscopic Tray, Product #TGL53.
- 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
- 9
- Distribution
- The product was shipped to hospitals and distributors located nationwide and worldwide.
- Lot, serial or model codes
- Lot Numbers: T4WP5P
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LFL
- 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