Z-0821-2016Class II

Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL

Name: Z-0821-2016 Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL
Creator: Medtronic
Published: 2015-12-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-12-02 / Terminated / root cause: manufacturing process

FDA source

Medtronic began a recall of Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA... on 2015-12-02. FDA classified it as Class II and gives the reason as "Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use". 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-0821-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Posted: 2016-02-18
Terminated: 2019-07-18
Recalling firm: Medtronic, Inc.
Product: Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Product code: GDW Staple, Implantable
Reason for recall: Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473. For questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in commerce: 327,797 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
Product codes and lots: Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X. Individual Lot Number: P5B0468X, P5E0523X, P5E0273X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0821-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-18
Z-0820-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-18
Z-0821-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-18
Z-0822-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-18

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