FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S
- Recall number
- Z-0966-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA9048S
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2004-07-20
- Terminated
- 2006-11-15
- Reason
- Stapler may clamp without the staples being fired into the tissue
- Root cause
- Other
- Action
- United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- LOT# P2H677 P2H678 P2J787 P2J788 P2L645 P2L646 P2L650 P2M226 P2M693 P3A652 P3B308 P3B613 P3C426 P3C432 P3C819 P3D953 P3E649 P3F116 P3F841 P3G16 P3G17 P3H281 P3H282 P3H447 P3H448 P3K27 P3K362 P3L1014 P3L1015 P3L1142 P3L231 P3L232 P3L45 P3L464 P3L465 P3L466 P3L731 P4A546 P4A643 P4A891 U2G15
- 510(k) numbers
- ["K013860"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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