Covidien recalls procedure kits with Auto Suture Endo GIA Universal Loading Units that may not form staples properly, risking bleeding during surgery.
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 procedure kits that contain Auto Suture Endo G:IA Universal Loading Units. These kits may not form staples correctly during surgery, which could lead to bleeding.
The device staples may not form properly when applied, which can prevent adequate bleeding control. This could lead to incomplete staple formation during surgery, potentially causing bleeding.
Surgical teams using the recalled procedure kits are affected. The risk is highest for patients undergoing surgery with these kits.
Check for lot numbers starting with 00Z2117 on the procedure kits. The kits contain Auto Suture Endo GIA Universal Loading Units.
Look for lot numbers starting with 00Z2117 on the procedure kits.
The device staples may not form properly, preventing adequate hemostasis and potentially causing bleeding during surgery.
Check for lot numbers starting with 00Z2117 on the procedure kits that contain Auto Suture Endo GIA Universal Loading Units.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0009-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0009-2021 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.
