FDA recall Z-0940-2026

Product

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

Reason for recall

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.

Distribution

Domestic: WI. International: Ireland.

Key facts

Status

Ongoing

Initiation date

2025-11-06

Report date

2025-12-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Germering, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2026