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Endo Gia(Tm) Staplers, Dst Series(Tm) Gia(Tm) Staplers, Dst Series(Tm) Ta(Tm) Staplers

by Covidien, Formerly US Surgical A Divison of Tyco H

510(k) K111825

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

24 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111825 Date25 Oct 2011ClearedStatusActive

Recalls

73 recalls · 24 ongoing · FDA

  • 9 recalls, same reason

    • Ongoing Z-0003-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0009-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0004-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0007-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0006-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0001-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0008-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0002-2021 FDA Class II initiated 12 Aug 2020
    • Ongoing Z-0005-2021 FDA Class II initiated 12 Aug 2020

    The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

  • 12 recalls, same reason

    • Ongoing Z-1832-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1834-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1828-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1826-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1827-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1836-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1833-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1835-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1830-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1825-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1829-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1831-2019 FDA Class II initiated 17 May 2019

    The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

  • 43 recalls, same reason

    • Ongoing Z-2503-2018 FDA Class II initiated 22 May 2018
    • Ongoing Z-2504-2018 FDA Class II initiated 22 May 2018
    • Ongoing Z-2505-2018 FDA Class II initiated 22 May 2018
    • Terminated Z-1826-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1840-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1821-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1820-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1858-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1819-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1838-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1854-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1818-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1815-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1825-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1847-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1862-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1855-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1829-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1844-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1842-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1824-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1837-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1828-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1859-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1848-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1830-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1817-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1843-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1831-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1863-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1823-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1833-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1849-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1839-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1814-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1850-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1852-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1832-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1816-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1865-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1822-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1866-2018 FDA Class II initiated 26 Apr 2018
    • Terminated Z-1834-2018 FDA Class II initiated 26 Apr 2018

    Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

  • 2 recalls, same reason

    • Completed Z-0748-2021 FDA Class II initiated 23 Nov 2020
    • Completed Z-0747-2021 FDA Class II initiated 23 Nov 2020

    May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis

    • Terminated Z-1264-2020 FDA Class II initiated 17 Jan 2020

    Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

    • Terminated Z-0636-2018 FDA Class II initiated 13 Sep 2017

    Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.

  • 4 recalls, same reason

    • Terminated Z-0819-2016 FDA Class II initiated 2 Dec 2015
    • Terminated Z-0821-2016 FDA Class II initiated 2 Dec 2015
    • Terminated Z-0820-2016 FDA Class II initiated 2 Dec 2015
    • Terminated Z-0822-2016 FDA Class II initiated 2 Dec 2015

    Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use

    • Terminated Z-1063-2013 FDA Class II initiated 11 Feb 2013

    Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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