medical Class I Updated 2019-11-06

Ethicon Endo-Surgery Inc recalls ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaf

Recalled Product

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R
View official government recall

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