Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients Recalled by Smith & Nephew Medical, Ltd. Due to Due to issues with battery depletion and inability...

Date: October 2, 2024
Company: Smith & Nephew Medical, Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew Medical, Ltd. directly.

Affected Products

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.

Quantity: 1589 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 13 states: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN, WI

Affected (13 states)Not affected

About Smith & Nephew Medical, Ltd.

Smith & Nephew Medical, Ltd. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report