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 p…

Recall date

October 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0516-2025

FDA classification

Class II

Brand / firm

Smith & Nephew Medical, Ltd.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.