Z-1264-2020Class II

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item...

Name: Z-1264-2020 Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item...
Creator: Covidien Llc
Published: 2020-01-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-01-17 / Terminated / root cause: packaging

FDA source

COVIDIEN LLC began a recall of Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND on 2020-01-17. FDA classified it as Class II and gives the reason as "Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1264-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-17
Posted: 2020-02-18
Terminated: 2022-07-29
Recalling firm: Medtronic, Inc.
Product: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Product code: GDW Staple, Implantable
Reason for recall: Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Medtronic notified consignees by letter via Federal Express and/or certified mail beginning January 17, 2020. The letter informs of the reason for recall, health risk and action to take: Immediately quarantine and discontinue use of the affected itemcode and lot; " Return affected product; Forward the information to anyone who they have distributed. Complete the Recalled Product Return Form even if you do not have inventory. Questions: Email Medtronic Post Market Vigilance at: [email protected].
Quantity in commerce: 2,180 units
Distribution: US Nationwide, Israel, and Japan
Product codes and lots: Lot Number: P9E0022Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1264-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1264-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

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)