Germering, Germany
PATH recalls
2 recalls recorded since 2018, most recently on 6 November 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 November 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0940-2026
- MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Ongoing Class II Medical devices
- Recall started
- 26 September 2023
- Reason
- Affected lots of product may experience technical distortions to a greater extent than expected.
- Distribution
- US States: FL, MO, OH, WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0404-2024, Z-0402-2024, Z-0401-2024, Z-0403-2024
- SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
- SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
- SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
- AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.