Covidien recalls EGIA 45 Articulating Med Thick Sulu devices with specific lot numbers 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 45 Articulating Med Thick Sulu surgical devices with certain lot numbers because they might be missing critical pin components. This could cause incomplete staple formation during surgery, increasing the risk of bleeding, infection, or serious complications like peritonitis or pneumothorax.
The device may be missing one of two pin components that keep the jaws aligned. Without these pins, the device might not form staples correctly during surgery, which could cause bleeding, infection, or serious complications like peritonitis or pneumothorax.
Surgical professionals who use the EGIA 45 Articulating Med Thick Sulu devices with the listed lot numbers are most at risk. Patients undergoing surgery with these devices could face complications if the device fails to form staples properly.
Check the lot numbers on the device: N4D0328KX through N9B0348KY. The product is identified as EGIA 45 ARTICULATING MED THICK SULU with Item Code EGIA45AMT.
Look for the lot number on the device packaging or label to determine if it is in the recalled list of lot numbers.
If the device is recalled, contact Covidien directly for instructions on how to return or replace the device.
The EGIA 45 Articulating Med Thick Sulu surgical device with Item Code EGIA45AMT and specific lot numbers listed in the recall.
Incomplete staple formation could lead to bleeding, anastomotic leak, peritonitis, pneumothorax, or infection.
Check the lot number on the device packaging or label against the list of recalled lot numbers provided 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-1826-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1826-2019 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.
