Reported Jul 25, 2018 · Ongoing
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
Covidien Medtronic
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 MEDTRONIC · 60 NIDDLETOWN AVE 2ND F · NORTH HAVEN, CT · 06473
Is this the product you have?
- Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
- Lot codes and dates
N7L0711KXN7L1141KXN7M0853KXN8B0419KXN7L0912KXN7M0241KXN8A0271KXN8C0012KXN7L0973KXN7M0353KXN8A0684KXN8C0143KXN7L1038KXN7M0366KXN8A0924KXN7M0996KXN7L0807KXN7M0548KXN8A1143KXN8A0173KXN7L1050KXN7M0617KXN8B0161KXN8A0488KXN7L1125KXN7M0745KXN8B0283KX & N8C0136KX
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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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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