Ethicon recalls ECHELON FLEX ENDOPATH 60mm staplers with specific product codes due to potential staple line failure causing surgery complications. Affected units may require replacement to prevent serious risks.
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 certain ECHELON FLEX ENDOPATH 60mm staplers that may have faulty anvil components. This could lead to weakened staples that might cause bleeding, infections, or surgery complications if not properly sealed.
The staplers may have an anvil component that doesn't meet specifications. This can cause staples to form improperly, weakening the staple line. If the staple line fails, it could lead to bleeding, infections, or the need for additional surgery.
Surgical staff and patients using the recalled staplers during procedures. Those with the specific product codes are most at risk.
Check for product code EC60A on the stapler. Affected units were sold with lot numbers T9408M, T94899, or T94A9Z.
Look for the product code EC60A on the stapler to confirm if it's affected.
Reach out to Ethicon Endo-Surgery Inc for guidance on next steps if the product is affected.
Ethicon recalls ECHELON FLEX ENDOPATH 60mm staplers with product code EC60A and specific lot numbers.
The staplers may have an anvil component that doesn't meet specifications, which can cause staples to form improperly and weaken the staple line.
Compromised staples could lead to bleeding, infections, or the need for additional surgery if the staple line fails.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0200-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0200-2020 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.
