Medtronic recalls Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal

Recalled February 24, 2016 · FDA recall Z-0821-2016 · Medtronic

Hazard

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

Units

327,797 units

Sold at

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.

Description

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

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.

Manufacturer(s)

Medtronic

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →