Covidien recalls EGIA 60 Articulating Extra Thick Sulu surgical devices due to potential missing pins causing incomplete staple formation, which may lead to bleeding, infection, or severe complications.
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 60 Articulating Extra Thick Sulu surgical devices because they may be missing critical pins that cause incomplete staple formation. This can lead to bleeding, infections, or serious complications like peritonitis or pneumothorax.
The device may have missing pins that cause the jaws to misalign. This leads to incomplete staple formation during surgery, which can cause bleeding, infections, or severe complications like peritonitis or pneumothorax.
Surgical professionals and patients who use the EGIA 60 Articulating Extra Thick Sulu devices are at risk. Those performing surgeries with this device may face complications if the pins are missing.
Check for the item code EGIA60AXT on the device. The product was sold with specific serial numbers N6B0079KX and N8A0029KX.
Inspect the device for missing pins that maintain jaw alignment. If pins are missing, stop using the device immediately.
The device may be missing critical pins that cause incomplete staple formation, leading to bleeding, infections, or severe complications.
Check for missing pins. If pins are missing, stop using the device immediately. Contact the manufacturer for further instructions.
Yes, missing pins can cause incomplete staple formation, which may lead to bleeding, infections, or severe complications like peritonitis or pneumothorax.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1828-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1828-2019 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.
