Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0940-2026 — MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

U.S. FDA — Device Enforcement · Germany · 2025-11-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0940-2026
Date of alert
2025-11-06
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
PATH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04260223141355
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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