Class II — Potential Health Hazard

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

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) Recalled by PATH Due to Following a component change in the DPOAE probe...

Date: November 6, 2025
Company: PATH
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 PATH directly.

Affected Products

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

Why Was This Recalled?

Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.

Where Was This Sold?

This product was distributed to 1 state: WI

Affected (1 state)Not affected

About PATH

PATH has 5 total recalls tracked by RecallDetector.

Related Recalls

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