# FDA recall Z-0940-2026

> **PATH** · Class II · device recall initiated 2025-11-06.

## Product

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

## Reason for recall

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.

## Key facts

- **Recall number:** Z-0940-2026
- **Recalling firm:** PATH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-06
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germering, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2026

## Citation

> AI Analytics. FDA recall Z-0940-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0940-2026. Source: US FDA. Licensed CC0.

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