Covidien recalls Endo GIA Auto Suture Gray Universal Articulating Loading Units with potential incomplete staple formation during surgery, risking bleeding. Affected units have specific lot numbers.
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 staplers that may not form staples properly during surgery, which could lead to bleeding. This recall affects specific lot numbers of the product used in surgical procedures.
The staplers may not form staples correctly during surgery, which can lead to incomplete hemostasis (stopping bleeding). This could cause bleeding if the staples fail to seal properly during procedures.
Surgical professionals using the Endo GIA Auto Suture staplers for procedures like abdominal, gynecologic, pediatric, or thoracic surgery. The risk is highest for those using the affected lot numbers.
Check the lot numbers on the product: T0A108X, T7H003X, T8D008X, T8K108X, T9G060X, T0E051X, T7L023X, T8H047X, T8M079X, T7G003X, T8D007X, T8K047X, T9F132X. The product is a gray universal articulating loading unit used in surgical procedures.
Identify the lot numbers on the product to determine if it is affected: T0A108X, T7H003X, T8D008X, T8K108X, T9G060X, T0E051X, T7L023X, T8H047X, T8M079X, T7G003X, T8D007X, T8K047X, T9F132X.
The staplers may not form staples properly during surgery, which can lead to incomplete hemostasis (stopping bleeding).
Lot numbers T0A108X, T7H003X, T8D008X, T8K108X, T9G060X, T0E051X, T7L023X, T8H047X, T8M079X, T7G003X, T8D007X, T8K047X, T9F132X.
No immediate stop is required; check the lot numbers to see if your unit is affected.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0001-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0001-2021 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.
