Medical Device Recall: 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 bo
Smith & Nephew Medical, Ltd. · October 2, 2024
Reason for Recall
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Product Description
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.
Distribution
U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
States Affected
AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN, WI
Quantity Affected
1589 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0516-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.