Reported Feb 26, 2020 · Terminated

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code:…

Covidien LLC

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 LLC · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection
  • in general surgery Item CodeEGIAUSTND
Lot codes and dates
  • Lot NumberP9E0022Y
Amount recalled
2,180 units

This recall covers 28 products

The agency filed one notice per product. You are reading one of them; the other 27 are below.

15 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 29, 2022 · Data as of Sep 19, 5:31 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.