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 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 of the product used in surgical procedures.
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 assembly of the stapler units.
Surgical professionals using the Endo GIA Auto Suture Universal Articulating Loading Units for procedures like abdominal, gynecologic, pediatric, or thoracic surgery are affected. The risk is low as the issue is limited to specific lot numbers and does not cause immediate harm.
Check the lot numbers listed: T0C085X, T8B048X, T8K049X, T8L087X, T9J072X, T7H002X, T8B049X, T8K095X, T9G027X, T9J099X, T7L026X, T8E063X, T8L084X, T9H043X, T9L073X, T7L027X, T8E064X, T8L085X, T9H115X, T9M016X, T8B014X, T8E075X, T8L086X, T9H116X, T9M111X, T8B015X, T8F074X. The product is used in surgical procedures for resection, transection, and anastomosis.
Verify if your unit has any of the listed lot numbers: T0C085X, T8B048X, T8K049X, T8L087X, T9J072X, T7H002X, T8B049X, T8K095X, T9G027X, T9J099X, T7L026X, T8E063X, T8L084X, T9H043X, T9L073X, T7L027X, T8E064X, T8L085X, T9H115X, T9M016X, T8B014X, T8E075X, T8L086X, T9H116X, T9M111X, T8B015X, T8F074X.
The device may not form staples properly during surgery, which can lead to incomplete hemostasis (stopping bleeding).
Check the lot numbers listed: T0C085X, T8B048X, T8K049X, T8L087X, T9J072X, T7H002X, T8B049X, T8K095X, T9G027X, T9J099X, T7L026X, T8E063X, T8L084X, T9H043X, T9L073X, T7L027X, T8E064X, T8L085X, T9H115X, T9M016X, T8B014X, T8E075X, T8L086X, T9H116X, T9M111X, T8B015X, T8F074X.
No action is needed if your unit does not have any of the listed 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-0003-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0003-2021 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.
