Covidien recalls EGIA 60 Articulating Med Thick Sulu devices due to potential missing pin components causing incomplete staple formation, which may lead to bleeding, infection, or serious 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 Med Thick Sulu surgical devices because they may be missing critical pin components. This can cause incomplete staple formation during surgery, increasing risks of bleeding, infection, or serious complications like peritonitis or pneumothorax.
The device may have missing pin components that maintain proper alignment of its jaws. Without these pins, the device cannot form staples correctly during surgery, potentially causing bleeding, infection, or life-threatening complications like peritonitis or pneumothorax.
Surgical professionals who use the EGIA 60 Articulating Med Thick Sulu devices are affected. Patients undergoing surgery with these devices are at risk of complications.
Check for the EGIA 60 Articulating Med Thick Sulu model with serial numbers listed in the recall (e.g., N4C1545KX, N4C1718KX, etc.). These devices were sold between 2019 and 2023.
Immediately stop using the recalled EGIA 60 Articulating Med Thick Sulu devices as they may be missing critical pin components that cause incomplete staple formation.
Covidien is recalling EGIA 60 Articulating Med Thick Sulu surgical devices due to potential missing pin components that can cause incomplete staple formation during surgery.
The device may cause incomplete staple formation, leading to bleeding, anastomotic leak, peritonitis, pneumothorax, infection, or sepsis.
Check the serial number on the device; the recall includes specific models with serial numbers like N4C1545KX, N4C1718KX, and others listed in the record.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1829-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1829-2019 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.