Covidien recalls Endo GIA Auto Suture Universal Articulating Loading Units with potential incomplete staple formation, risking bleeding during surgery. Affected units have specific lot numbers and were sold for abdominal, gynecologic, and other surgical procedures.
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, which could lead to bleeding. This recall affects specific lot numbers used in abdominal, gynecologic, pediatric, and thoracic surgeries.
The device may not form staples correctly during surgery, which can lead to incomplete hemostasis (stopping bleeding). This error occurs due to a manufacturing defect in the unit's assembly, potentially causing bleeding during procedures.
Surgical teams using the Endo GIA Auto Suture Universal Articulating Loading Units for abdominal, gynecologic, pediatric, or thoracic procedures are most at risk. The recall applies to specific lot numbers sold between 2019 and 2023.
Check the lot number on the unit, which is listed in the recall (e.g., T0A016X, T8D009X). The product is used in abdominal, gynecologic, pediatric, and thoracic surgeries for procedures like resection and anastomosis.
Look for the lot number on the unit, which is one of the listed codes (e.g., T0A016X, T8D009X).
The device may not form staples properly during surgery, which can lead to incomplete hemostasis (bleeding).
Check the lot number on the unit; affected units have specific codes listed in the recall (e.g., T0A016X, T8D009X).
No action is required for the product itself; the recall only identifies affected units for verification. If your unit has a listed lot number, you should check it.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0002-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0002-2021 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.
