Z-0004-2021Class II

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 -

Name: Z-0004-2021 Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 -
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 Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in... 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-0004-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-12
Posted: 2020-10-01
Recalling firm: Medtronic, Inc.
Product: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - 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: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2021
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)