Ethicon recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Staplers with specific product codes due to potential for malformed staples that could cause surgery complications or death.
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 Powered Plus ENDOPATH 6:0mm staplers that may have an anvil component out of specification. This could lead to malformed staples, risking staple line failure during surgery, which might cause prolonged procedures, bleeding, or even death.
The staplers may have an anvil component that doesn't meet specifications. This can cause staples to be malformed, weakening the staple line. If the staple line fails during surgery, it could lead to bleeding, prolonged procedures, or death.
Surgical professionals who own or use the recalled ECHELON FLEX Powered Plus ENDOPATH 60mm staplers with the listed product codes are affected. Patients undergoing surgery with these devices face the highest risk of complications.
Check for the product code PLEE60A on the stapler. The affected units were sold with specific lot numbers: T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, T9413Z.
Immediately stop using the recalled ECHELON FLEX Powered Plus ENDOPATH 60mm staplers with the listed product codes as they may cause serious complications.
The affected product codes are PLEE60A with lot numbers: T93Z1G, T93Y4M, T94045, T94117, T93X17, T94087, T93Z2X, T9405L, T94253, T93X95, T93Z75, T93Z2W, T9413Z.
The staplers may contain an anvil component out of specification, which can lead to malformed staples and compromise staple line integrity during surgery.
Malformed staples could cause staple line failure, leading to prolonged surgery, postoperative bleeding, hemorrhagic shock, additional surgery, or death.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0202-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0202-2020 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.
