Recall Z-0516-2025— Smith & Nephew Medical, Ltd.

Name: FDA recall Z-0516-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Medical, Ltd., initiated 2024-10-02. It names one FDA 510(k) clearance: K223041. 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.. Reason: Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained..

Recalling firm: Smith & Nephew Medical, Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2024-10-02
Firm location: Hull, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K223041 — Renasys Edge (66803126)Smith & Nephew Medical Limited·cleared 2022-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.