CLASS II ONGOING Device recall · Reported 25 Jul 2018 · FDA Enforcement Report

Tri-Staple 2.0 Curved Tip Intelligent Reload for use recalled

Covidien Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system, distributed nationwide in the US. The recall was initiated on 22 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN7G0756KX & N7L0819KX

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-2516-2018
FDA event ID: 80423
Recalling firm: Covidien Medtronic, NORTH HAVEN, CT
Classification: Class II
Status: Ongoing
Recall initiated: 22 May 2018
FDA classified: 19 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 May 2018	Recall initiated by company
19 Jul 2018	Classified by FDA	+58 days
25 Jul 2018	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

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV

Where it was distributed

Nationwide U.S.A. Internationally to: Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates & United Kingdom

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

N7G0756KX & N7L0819KX

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

13 other products · FDA event 80423

This product is part of a recall event; the main page for the event is Endo GIA Articulating Medium/Thick Reload with Tri-Staple Technology recalled.

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018	CLASS II	Endo GIA Articulating Medium/Thick Reload with Tri-Staple Technology recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Tri-Staple 2.0 Curved Tip Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Gray Articulating Vascular Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Articulating Vascular/Medium Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Tri-Staple 2.0 Intelligent Reload for use recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Articulating Medium/Thick Reload with Tri-StapleTechnology recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Articulating Vascular/Medium Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Extra Thick Black Articulating Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Extra Thick Black Articulating Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Tri-Staple 2.0 Curved Tip Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Tri-Staple 2.0 Intelligent Reload for use recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Endo GIA Curved Tip Articulating Vascular/Medium Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018	CLASS II	Tri-Staple 2.0 Black Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide

More recalls from Covidien Medtronic

All 55

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Tri-Staple 2.0 Black Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Endo GIA Curved Tip Articulating Vascular/Medium Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Tri-Staple 2.0 Intelligent Reload for use recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Tri-Staple 2.0 Curved Tip Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Endo GIA Extra Thick Black Articulating Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide

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