Covidien recalls Endo GIA Auto Suture Universal Loading Units (item code 030457) due to risk of incomplete staple formation during surgery, potentially causing bleeding. Affected units have specific lot numbers listed in the recall notice.
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 Loading Units (item code 030457) because they may not form staples properly during surgery. This could lead to bleeding or incomplete hemostasis, which is serious for surgical procedures.
The device may not properly form staples when used, which can cause incomplete hemostasis (stopping bleeding). This means blood could continue to flow during surgery, increasing the risk of bleeding complications for patients.
Surgical professionals using the Endo GIA universal staplers in abdominal, gynecologic, pediatric, or thoracic procedures are most at risk. Patients undergoing surgery with these devices could experience bleeding if staples don't form correctly.
Check the lot number on the unit, which is listed in the recall notice as T0A104X through T9L034X. The product is used in specific surgical procedures and has item code 030457.
Look for the lot number on the device, which should be one of the listed codes (T0A104X to T9L034X).
Reach out to Covidien directly for further instructions if you have the recalled unit.
The units may not form staples properly during surgery, which can lead to incomplete hemostasis and bleeding.
The device is used in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and anastomosis.
Check the lot number on the unit; it should be one of the listed codes (T0A104X through T9L034X).
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0007-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0007-2021 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.
