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Endo GIA 030457

by Covidien LP

Endo GIA 030457 is a Class II device made by Covidien LP, cleared under FDA 510(k) K111825 on 25 Oct 2011 and listed in FDA GUDID since 28 Aug 2015 (UDI-DI 10884523002881), active as of 23 Oct 2026. 73 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K111825

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884523002881 UDI-DI Date28 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111825 Date25 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111825 decided 25 Oct 2011 Active
  • FDA GUDID UDI-DI 10884523002881 listed 28 Aug 2015 Listed

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

Timeline

75 dated events

  1. Recall initiated FDA recalls Z-0009-2021
  2. Recall initiated FDA recalls Z-0004-2021
  3. Recall initiated FDA recalls Z-0007-2021
  4. Recall initiated FDA recalls Z-0006-2021
  5. Recall initiated FDA recalls Z-0001-2021
  6. Recall initiated FDA recalls Z-0008-2021
  7. Recall initiated FDA recalls Z-0002-2021
  8. Recall initiated FDA recalls Z-0005-2021
  9. Recall initiated FDA recalls Z-0748-2021
  10. Recall initiated FDA recalls Z-0747-2021

65 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endo GIA
Generic name
Surgical staple loading unit, non-cutting
Model / reference
030457
Primary DI / UDI-DI
10884523002881
510(k) Number
FDA product code
GDW, GAG
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class II
Regulation number
878.4750, 878.4740
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Height — 2.5 Millimeter
Length — 60 Millimeter

Related devices

Category: Surgical staple loading unit, non-cutting

Cleared under the same submission (K111825)

and 8 more cleared under K111825

Similar devices in this category

Other devices filed under Surgical staple loading unit, non-cutting.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)