Class II — Potential Health Hazard

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

SOZO Bilateral Arm L-Dex Software Recalled by Impedimed Limited Due to Bilateral L-Dex assessment software does not have the...

Date: August 17, 2023
Company: Impedimed Limited
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 Impedimed Limited directly.

Affected Products

SOZO Bilateral Arm L-Dex Software

Quantity: 354

Why Was This Recalled?

Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and more aggressive intervention.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Impedimed Limited

Impedimed Limited has 1 total recall tracked by RecallDetector.

Related Recalls

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