FDA (Devices) recall action 83897
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.
Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide due to out-of-specification anvil components that may compromise staple line integrity.
Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.
Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.