CLASS II Device recall · Reported 24 Feb 2016 · FDA Enforcement Report

Covidien Endo GIA Ultra Universal XL Stapler Handle recalled

Medtronic is recalling Covidien Endo GIA Ultra Universal XL Stapler Handle, distributed nationwide in the US. The recall was initiated on 2 Dec 2015 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled327,797 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0821-2016
FDA event ID: 72749
Recalling firm: Medtronic, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2015
FDA classified: 18 Feb 2016
Reported: 24 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

2 Dec 2015	Recall initiated by company
18 Feb 2016	Classified by FDA	+78 days
24 Feb 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 72749

This product is part of a recall event; the main page for the event is Best Practice Kits containing certain production lots recalled.

Reported	Class	Recall	Company	Reason	Where
24 Feb 2016	CLASS II	Best Practice Kits containing certain production lots recalled	Medtronic	Device Malfunction	Nationwide
24 Feb 2016	CLASS II	Covidien Endo GIA Ultra Universal Short Stapler Handle recalled	Medtronic	Device Malfunction	Nationwide
24 Feb 2016	CLASS II	Covidien Endo GIA Ultra Universal Standard Stapler Handle recalled	Medtronic	Device Malfunction	Nationwide

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