Covidien recalls Endo GIA Auto Suture Universal Loading Units with potential for incomplete staple formation during surgery, risking bleeding. Affected units have specific lot numbers. Contact for remedy.
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Covidien is recalling certain Endo GIA Auto Suture Universal Loading Units that may not form staples properly during surgery, which could lead to bleeding. Affected units have specific lot numbers listed in the recall notice.
The device staples may not form correctly during use, which can prevent proper hemostasis (stopping bleeding). This could lead to incomplete staple formation and potential bleeding during surgery.
Surgical professionals using the Endo GIA universal staplers for procedures like abdominal or gynecologic surgery. Those with the listed lot numbers are most at risk.
Check the lot number on the unit, which is listed in the recall notice. The affected units are identified by specific lot numbers including T0A018X through T9D125X.
Look for the lot number on the unit, which is listed in the recall notice (e.g., T0A018X, T8B045X, etc.).
The device staples may not form properly during use, which can prevent adequate hemostasis (stopping bleeding) and lead to incomplete staple formation.
Affected lot numbers include T0A018X, T8B045X, T8E051X, T8L052X, T9E050X, and others as listed in the recall notice.
The recall does not specify a stop-use instruction; the remedy is null, so users should check the lot number and contact the manufacturer if needed.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0005-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0005-2021 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.
