Reported Oct 7, 2020 · Ongoing

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA…

Covidien, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm
  • Item Code 030458 - Product UsageThe Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis
Lot codes and dates
  • Lot Numbers

    166 of 166 codes

    • 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
Amount recalled
900,007 total

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.