Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft Recalled by Ethicon Endo-Surgery Inc Due to The staplers may contain an out of specification...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon Endo-Surgery Inc directly.
Affected Products
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Quantity: 255 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ethicon Endo-Surgery Inc
Ethicon Endo-Surgery Inc has 54 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report