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FDANovember 6, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

path

UPCs

04260223141355

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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