Z-0007-2021Class II

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 -

Name: Z-0007-2021 Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 -
Creator: Covidien, LP
Published: 2020-08-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-08-12 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic... on 2020-08-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0007-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-12
Posted: 2020-10-01
Recalling firm: Medtronic, Inc.
Product: Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Product code: GDW Staple, Implantable
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 8/12/20 were sent to customers. Required Actions: 1.Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listedon Attachment A. 2.Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3.If you have distributed the Covidien Endo GIA" Auto Suture" universal articulating loading units listed on Attachment A, please promptly forward the information from this letter to those recipients. 4.Complete the Recalled Product Return Form even if you do not have inventory. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 900,007 total
Distribution: Worldwide distribution - US Nationwide and Global Distribution.
Product codes and lots: Lot Numbers: T0A104X T7L042X T8D056X T8L032X T9D044X T0C041X T7L043X T8E053X T8L051X T9D047X T0C042X T7L044X T8E054X T8L104X T9D048X T7F018X T7L045X T8F041X T8L105X T9D049X T7F023X T7L046X T8F042X T8M045X T9D055X T7F024X T7L047X T8F043X T9A007X T9E025X T7J006X T8A005X T8F075X T9A008X T9F051X T7J011X T8A006X T8J011X T9B041X T9H144X T7J012X T8A041X T8K063X T9B042X T9J034X T7K030X T8A042X T8L028X T9C067X T9K078X T7K031X T8C039X T8L029X T9C068X T9K079X T7K032X T8C040X T8L030X T9C146X T9L020X T7K033X T8D055X T8L031X T9C157X T9L034X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0002-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0003-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0004-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0005-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0006-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0007-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0008-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01
Z-0009-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-07	2020-10-01

Product code GDW

K111825Class IIEndo Gia(tm) Staplers, Dst Series(tm) Gia(tm) Staplers, Dst Series(tm) Ta(tm) StaplersCovidien, Formerly US Surgical A Divison of Tyco H / cleared 2011-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)