Ethicon recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler with potential for malformed staples causing surgery complications. Affected units have specific product codes and lots.
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Ethicon is recalling a specific surgical stapler model due to a risk of malformed staples that could lead to serious complications like bleeding or surgery failure. This affects surgeons and hospitals using the recalled product.
The stapler may have an anvil component that doesn't meet specifications, causing staples to form incorrectly. This can weaken the staple line, potentially leading to bleeding, prolonged surgery, or even death if the staple line fails during procedures.
Surgeons and hospitals that use the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler with Product Code PCEE60A are most at risk. The hazard primarily impacts surgical procedures where the stapler is used.
Check for the product code PCEE60A on the stapler. Affected units were sold with specific lots: T93Z9Y and T9411A. The stapler has a 60mm size and 280mm shaft.
Look for the product code PCEE60A on the stapler to confirm if it's affected.
Reach out to Ethicon Endo-Surgery Inc for further assistance if you have the recalled product.
The stapler may have an anvil component that doesn't meet specifications, causing staples to form incorrectly. This can weaken the staple line and lead to complications like bleeding or surgery failure.
Check for the product code PCEE60A and specific lots: T93Z9Y or T9411A. The stapler has a 60mm size and 280mm shaft.
Contact Ethicon Endo-Surgery Inc for guidance. They may provide instructions for further action.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0201-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0201-2020 from Ethicon. 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.
