Covidien recalls 12mm Endo GIA Ultra Universal Staplers for potential infection risk if sterile barrier is compromised. Affected items have specific item codes and lot numbers.
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Covidien is recalling its Endo GIA Ultra Universal Staplers (12mm) used in general surgery because the sterile barrier might be compromised, increasing infection risk. This affects surgeons and surgical teams who use these devices during procedures.
The sterile barrier in these surgical staplers could become compromised, potentially allowing bacteria to enter the surgical site. This increases the risk of infection after surgery if the barrier is not properly maintained.
Surgeons and surgical teams using the Endo GIA Ultra Universal Stapler 12mm for general surgery procedures are most at risk. The recall applies to specific item codes and lot numbers.
Check for the item code EGIAUSTND and lot number P9E0:0022Y on the product. These devices are intended for resection and transection in general surgery procedures.
Look for item code EGIAUSTND and lot number P9E0022Y on the device.
The sterile barrier could be compromised, potentially increasing infection risk during surgery.
Check for item code EGIAUSTND and lot number P9E0022Y. If you have these details, contact Covidien for further instructions.
No immediate action is needed. The recall is for potential infection risk if the sterile barrier is compromised, which requires checking product details.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1264-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1264-2020 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.
