Covidien recalls EGIA 45 Articulating Xtra Thick Sulu surgical devices that may cause incomplete staple formation, leading to bleeding, infection, or severe complications. Affected units include specific item codes.
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Covidien is recalling EGIA 45 Artic: Xtra Thick Sulu surgical devices that may not form staples properly, causing bleeding, infections, or serious complications. This recall affects specific item codes sold under the product name.
The device may be missing critical pin components that keep the jaws aligned. Without proper alignment, staples form incompletely, which can cause bleeding, infections, or severe complications like peritonitis or pneumothorax.
Surgical professionals and patients who used the recalled EGIA 45 Articulating Xtra Thick Sulu devices during procedures are most at risk. The recall applies to specific item codes sold by the manufacturer.
Check for the item code EGIA45AXT on the device or packaging. The product was sold with specific codes N6B0080KX and N6C0975KX.
Inspect the device for missing pin components that maintain jaw alignment.
EGIA 45 Articulating Xtra Thick Sulu surgical devices with item code EGIA45AXT.
Incomplete staple formation may cause bleeding, infection, peritonitis, or pneumothorax.
Look for item code EGIA45AXT on the device or packaging, with specific codes N6B0080KX or N6C0975KX.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1827-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1827-2019 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
