CLASS II ONGOING Device recall · Reported 7 Oct 2020 · FDA Enforcement Report

Endo GIA Auto Suture Universal Articulating Loading Unit recalled

Covidien is recalling Endo GIA Auto Suture Universal Articulating Loading Unit, distributed nationwide in the US. The recall was initiated on 12 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F019X T8C034X T8H051X T9C156X T9J097X T7F021X T8C035X T8H052X T9E030X T9J098X T7F022X T8C041X T8H072X T9E069X T9K002X T7J003X T8C042X T8J027X T9E070X T9K068X T7J004X T8C044X T8J038X T9E071X T9K104X T7J005X T8D011X T8J041X T9E072X T9K105X T7J013X T8D057X T8J042X T9E111X T9L019X T7J020X T8D058X T8J058X T9E119X T9L074X T7J032X T8D059X T8J067X T9E120X T9L075X T7L028X T8D060X T8K007X T9F026X T9L102X T7L029X T8D061X T8K009X T9F049X T9L103X T7L030X T8D062X T8K043X T9F050X T9M109X T7L048X T8E047X T8K050X T9F078X T9M110X T7L049X

Quantity recalled900,007 total

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-0008-2021
FDA event ID: 86214
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 12 Aug 2020
FDA classified: 1 Oct 2020
Reported: 7 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

12 Aug 2020	Recall initiated by company
1 Oct 2020	Classified by FDA	+50 days
7 Oct 2020	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

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

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

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Where it was distributed

Worldwide distribution - US Nationwide and Global Distribution.

Nationwide

Questions about this recall

Why was it recalled?

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Which lots are affected?

Lot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F019X T8C034X T8H051X T9C156X T9J097X T7F021X T8C035X T8H052X T9E030X T9J098X T7F022X T8C041X T8H072X T9E069X T9K002X T7J003X T8C042X T8J027X T9E070X T9K068X T7J004X T8C044X T8J038X T9E071X T9K104X T7J005X T8D011X T8J041X T9E072X T9K105X T7J013X T8D057X T8J042X T9E111X T9L019X T7J020X T8D058X T8J058X T9E119X T9L074X T7J032X T8D059X T8J067X T9E120X T9L075X T7L028X T8D060X T8K007X T9F026X T9L102X T7L029X T8D061X T8K009X T9F049X T9L103X T7L030X T8D062X T8K043X T9F050X T9M109X T7L048X T8E047X T8K050X T9F078X T9M110X T7L049X

Where was it sold?

Worldwide distribution - US Nationwide and Global Distribution.

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

8 other products · FDA event 86214

This product is part of a recall event; the main page for the event is Endo GIA Auto Suture Universal Articulating Loading Unit recalled.

Reported	Class	Recall	Company	Reason	Where
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Articulating Loading Unit recalled	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Best Practices Procedure Kits recalled by Covidien	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Loading Unit recalled by Covidien	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Gray Universal Articulating Loading Unit recalled	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Articulating Loading Unit recalled	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Loading Unit recalled by Covidien	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Articulating Loading Unit recalled	Covidien	Device Malfunction	Nationwide
7 Oct 2020	CLASS II	Endo GIA Auto Suture Universal Articulating Loading Unit recalled	Covidien	Device Malfunction	Nationwide

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