FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S
- Recall number
- Z-0961-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S
- 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# P2J450 P2J795 P2J796 P2J797 P2J798 P2L657 P2M193 P2M241 P2M542 P2M98 P3A412 P3A91 P3A92 P3A93 P3B345 P3B608 P3B609 P3B610 P3C238 P3D246 P3D568 P3D947 P3E237 P3E300 P3E523 P3F113 P3F684 P3G960 P3J237 P3J43 P3J44 P3J459 P3J711 P3K15 P3L1135 P3L1136 P3L1152 P3L235 P3L236 P3L448 P3L449 P3L629 P3L997 P3L998 P3M672 P3M673 P4A554 P4A637 P4A883 P4B585 U2E11 U2F13 U2F17 U2G02 U2G03 U2G11 U2G13
- 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