Smith & Nephew Medical, Ltd. recalls RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may

Recalled December 4, 2024 · FDA recall Z-0516-2025 · Smith & Nephew Medical

Hazard

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. · FDA Class II

Units

1589 units

Sold at

U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada

Description

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Product

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

Manufacturer(s)

Smith & Nephew Medical, Ltd.

Made in

United Kingdom

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →