FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 30 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA30348S
- Recall number
- Z-0960-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 30 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA30348S
- 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# P2J506 P2J508 P2K1032 P2K186 P2K614 P2L333 P2M236 P2M549 P2M550 P2M703 P3A1149 P3A1150 P3A453 P3B340 P3C803 P3D86 P3E234 P3E296 P3G10 P3H287 P3H639 P3J245 P3J458 P3K10 P3K11 P3L1009 P3L1010 P3L1131 P3L1132 P3L233 P3L234 P3L43 P3L443 P3L445 P3L446 P3L727 P3L87 P3M366 P3M367 P3M550 P4B161 U2H01 U2H09
- 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