Covidien recalls Endo GIA Auto Suture 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 suture staplers that may not form staples properly during surgery, which could lead to bleeding. This affects specific lot numbers of the 45 mm - 2.0 mm model.
The staplers may not form staples correctly during use, which can cause bleeding during surgery. This happens because the device's assembly error prevents proper staple formation.
Surgical professionals using the Endo GIA staplers for procedures like abdominal or gynecological surgery. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot number on the device, which should be one of the listed codes: T7F017X, T7J023X, T7L032X, T7L034X, T8L100X, T7F025X, T7J024X, T7L033X, T7L035X, T9F138X, T7F026X, or T7K020X.
Look for the lot number on the device, which should be one of the listed codes.
The Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453.
Lot numbers: T7F017X, T7J023X, T7L032X, T7L034X, T8L100X, T7F025X, T7J024X, T7L033X, T7L035X, T9F138X, T7F026X, T7K020X.
The recall does not mention a fix or remedy; the device may need to be replaced if it has the affected lot numbers.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0004-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0004-2021 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.
