Covidien recalls EGIA 30 Articulating Med Thick Sulu surgical devices with missing pins that may cause bleeding, leaks, or infections. Affected units have specific lot numbers.
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 30 Articulating Med Thick Sulu surgical devices that might have missing pins. This could lead to incomplete staple formation, causing bleeding, infections, or serious complications during surgery.
The device may be missing one of two pin components that keep the jaws aligned. Without these pins, staples form incorrectly, which can cause bleeding, leaks in the surgical site, infections, or serious complications like pneumothorax.
Surgical professionals and hospitals using the EGIA 30 Articulating Med Thick Sulu device with specific lot numbers are affected. Patients undergoing surgery with this device are at risk of bleeding, infections, or severe complications.
Check the lot numbers on the device: N5A0871KX, N7A0527KX, N7E0441KX, N8J0039KX, N8J0527KX, or N8J0820KX. The product is sold under the brand name Covidien.
Immediately stop using the EGIA 30 Articulating Med Thick Sulu device if it has the listed lot numbers.
Affected lot numbers are N5A0871KX, N7A0527KX, N7E0441KX, N8J0039KX, N8J0527KX, and N8J0820KX.
The device may be missing pin components that maintain jaw alignment, leading to incomplete staple formation and risks of bleeding, infections, or serious complications.
Check the lot numbers on the device; affected units have specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1825-2019 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.