FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA6048S
- Recall number
- Z-0964-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 60 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA6048S
- 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 # P2H15 P2J240 P2J240A P2J265 P2J784 P2J786 P2K827 P2L124 P2L655 P2L656 P2M96 P3A418 P3A648 P3A940 P3A98 P3C01 P3C423 P3C626 P3D21 P3D280 P3D584 P3D951 P3F468 P3G914 P3H249 P3H444R P3H566 P3J238 P3J462 P3J463 P3L1149 P3L1150 P3L229 P3L230 P3L240 P3L241 P3L458 P3L459 P3L460 P3L638 P3L730 P3L994 P3L995 P3L996 P4A138 P4A889 P4B270 P4B591 P4B714 P4B716 U2E13R U2F08 U2F28 U2F30
- 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