Home / Recalls / Medtronic / Z-0821-2016

Z-0821-2016 Class II Terminated

Recalled by Medtronic — North Haven, CT

FDA device recall Z-0821-2016 was initiated by Medtronic on Dec 2, 2015 and is designated Class II. Reason for recall: Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use The recall status is terminated (terminated Jul 18, 2019). Affected quantity: 327,797 units.

Recall Details

Product Type: Devices
Report Date: Feb 24, 2016
Initiation Date: Dec 2, 2015
Termination Date: Jul 18, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 327,797 units

Product Description

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.

Reason for Recall

Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use

Distribution Pattern

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.

Code Information

Lot numbers within each range are affected: Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X. Individual Lot Number: P5B0468X, P5E0523X, P5E0273X

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0821-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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