Z-0636-2018Class II

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and...

Name: Z-0636-2018 Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and...
Creator: Covidien LLC
Published: 2017-09-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-09-13 / Terminated

FDA source

Covidien LLC began a recall of Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and... on 2017-09-13. FDA classified it as Class II and gives the reason as "Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0636-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Posted: 2018-02-16
Terminated: 2019-06-28
Recalling firm: Medtronic, Inc.
Product: Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Product code: GDW Staple, Implantable
Reason for recall: Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
FDA root cause: Under Investigation by firm
Action: All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.
Quantity in commerce: 3,816
Distribution: Nationally
Product codes and lots: N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0636-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)