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PATH recalls MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Recalled December 24, 2025 · FDA recall Z-0940-2026 · PATH
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. · FDA Class II
Sold at
Domestic: WI. International: Ireland.
Description
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.
Product
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Manufacturer(s)
PATH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →