Z-0819-2016Class II

Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT

Name: Z-0819-2016 Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT
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 Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and... 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-0819-2016
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 Short Stapler Handle Ref: EGIAUSHORT 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: 364,768 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: RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0289X P5C0196X through P5C0197X P5C0304X through P5C0307X P5C0796X through P5C0798X P5D0049X through P5D0051X P5D0146X through P5D0148X P5E0261X through P5E0262X P5F0158X through P5F0161X INDIVIDUAL LOT NUMBERS (in addition to ranges) N3F0260RX N3F0266RX N3F0267RX P5C0201X P5D0538X P5E0680X P5E0682X P5E0686X P5E0760X P5E0762X P5E0765X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2016
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)