Recall
Class II — PATH
| Recalling firm | PATH |
|---|---|
| Registered facility | PATH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) |
| Distribution | Domestic: WI. International: Ireland. |
| Initiated | 2025-11-06 |
| Classified | 2025-12-18 |
| Recall number | Z-0940-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PATH (Z-0940-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97894/
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