Z-0908-2018Class II

Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology...

Name: Z-0908-2018 Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology...
Creator: Covidien LLC
Published: 2017-09-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-09-15 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive... on 2017-09-15. FDA classified it as Class II and gives the reason as "The device cartridge disengaged during use due to manufacturing error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0908-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-15
Posted: 2018-03-06
Terminated: 2018-12-19
Recalling firm: Medtronic, Inc.
Product: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Product code: GDW Staple, Implantable
Reason for recall: The device cartridge disengaged during use due to manufacturing error.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: [email protected]. For further questions, please call (203) 492-5000.
Quantity in commerce: 163
Distribution: Internationally, including Japan. No USA Customers
Product codes and lots: Product number: EGIARADXT Lot code: N6L0351X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0908-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0908-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05

Product code GDW

K132493Class IIEndo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC / cleared 2013-10-23

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)