Brand
PATH
5 federal recalls on file, showing the 1 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for PATH and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-24FDA-DeviceClass IIStop using affected Madsen Accuscreen DPOAE probes
A speaker component change in certain PATH Madsen Accuscreen DPOAE probes can cause technical distortions that mimic real hearing responses. This may result in incorrect "PASS" outcomes on infant hearing screening tests when a baby should have failed. The issue occurs when high stimulus levels combine with the device's sensitivity settings.
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