FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series Ref: TA3035S
- Recall number
- Z-0959-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series Ref: TA3035S
- 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# P2J505 P2J971 P2K1031 P2K813 P2L332 P2L603 P2L604 P2M227 P2M228 P2M235 P2M82 P3A1151 P3A323 P3A443 P3A908 P3B336 P3B607 P3C710 P3C802 P3D563 P3D944 P3E233 P3E294 P3G08 P3G09 P3G417 P3G621 P3G769 P3H288 P3H638 P3J41 P3J456 P3K05 P3K06 P3K07 P3K08 P3L1007 P3L1008 P3L11 P3L1129 P3L1130 P3L12 P3L243 P3L42 P3L425 P3L440 P3L441 P3M368 P3M369 P4A634 P4A881 U2H02 U2H08
- 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