Ethicon recalls ECHELON FLEX Powered Plus ENDOPATH 60mm staplers with specific product codes due to risk of malformed staples causing surgery complications.
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 ENDOP: 60mm staplers that may have faulty anvil components. This could lead to weakened staples, potentially causing surgery to last longer, 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, it might lead to prolonged surgery, bleeding, or death.
Surgical professionals who use the recalled staplers for procedures. Patients undergoing surgery with these devices face the highest risk of complications.
Check for product codes: PSEE60A with lots T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R. These staplers were sold with specific shaft lengths.
Immediately stop using the recalled staplers as they may cause serious complications during surgery.
Product codes PSEE60A with lots T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R.
The staplers may have an anvil component that doesn't meet specifications, leading to malformed staples that could compromise surgery safety.
Malformed staples could cause prolonged surgery, 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-0203-2020 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-0203-2020 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.
