FDA Medical Device Recalls (openFDA)
United States Surgical: Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA9035S
- Recall number
- Z-0965-04
- Recalling firm
- United States Surgical
- Product
- Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA9035S
- 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# P2H679 P2J642 P2K1113 P2K534 P2K66 P2L609 P2L610 P2L611 P2L649 P2M692 P3A650 P3C425 P3C800 P3E304 P3F686 P3G15 P3G414 P3J249 P3J250 P3J256 P3L1013 P3L1141 P3L242 P3L44 P3L462 P3L639 P4A547 P4A642 P4A890 P4B727 U2G21
- 510(k) numbers
- not on file
- 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