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 800ML CANISTER WITH Solidifier- Indicated for patients who Recalled by Smith & Nephew Medical, Ltd. Due to Black particulate matter from the carbon filter component...

Date: March 11, 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 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140

Quantity: 675 units

Why Was This Recalled?

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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