Covidien recalls Endo GIA Auto Suture Universal Articulating Loading Units with potential incomplete staple formation causing bleeding during surgery. 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 Endo GIA Auto Suture Universal Articulating Loading Units that may not form staples properly during surgery, risking bleeding. This affects specific units with listed lot numbers.
The device may not properly form staples when used, which could lead to incomplete hemostasis (stopping bleeding) during surgery. This could result in bleeding if the staples fail to seal properly.
Surgical professionals using the Endo GIA units for procedures like abdominal or gynecologic surgery. The risk is low as the issue is a potential staple formation error rather than immediate danger.
Check the lot number on the unit, which is listed in the recall (e.g., T0A013X, T7L050X). The product is used in abdominal, gynecologic, pediatric, and thoracic surgeries.
Look for the lot number on the unit, which should match one of the listed codes (e.g., T0A013X, T7L050X).
The device may not properly form staples during application, which could lead to incomplete hemostasis (bleeding) during surgery.
Check the lot number on the unit; affected units have specific codes listed in the recall (e.g., T0A013X, T7L050X).
No action is needed if your unit's lot number is not in the list of affected codes.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0008-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0008-2021 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.
