Reported Oct 7, 2020 · Ongoing

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have…

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 Loading Unit
  • Item Code 030457 - 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

    65 of 65 codes

    • T0A104X
    • T7L042X
    • T8D056X
    • T8L032X
    • T9D044X
    • T0C041X
    • T7L043X
    • T8E053X
    • T8L051X
    • T9D047X
    • T0C042X
    • T7L044X
    • T8E054X
    • T8L104X
    • T9D048X
    • T7F018X
    • T7L045X
    • T8F041X
    • T8L105X
    • T9D049X
    • T7F023X
    • T7L046X
    • T8F042X
    • T8M045X
    • T9D055X
    • T7F024X
    • T7L047X
    • T8F043X
    • T9A007X
    • T9E025X
    • T7J006X
    • T8A005X
    • T8F075X
    • T9A008X
    • T9F051X
    • T7J011X
    • T8A006X
    • T8J011X
    • T9B041X
    • T9H144X
    • T7J012X
    • T8A041X
    • T8K063X
    • T9B042X
    • T9J034X
    • T7K030X
    • T8A042X
    • T8L028X
    • T9C067X
    • T9K078X
    • T7K031X
    • T8C039X
    • T8L029X
    • T9C068X
    • T9K079X
    • T7K032X
    • T8C040X
    • T8L030X
    • T9C146X
    • T9L020X
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, 7:02 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.