PATH
5 federal recalls on file. 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 IIMADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
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.
- 2023-12-06FDA-DeviceClass IISENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DeviceClass IIAuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DeviceClass IISENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Affected lots of product may experience technical distortions to a greater extent than expected.
- 2023-12-06FDA-DeviceClass IISENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Affected lots of product may experience technical distortions to a greater extent than expected.
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