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

Recall date

November 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0940-2026

FDA classification

Class II

Brand / firm

PATH

Sold / distributed

Domestic: WI. International: Ireland.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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