MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe — Class II medical device recall Z-0940-2026
Ongoing recall by PATH, reported 2025-12-24, distributed in WI. Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high
| Recall number | Z-0940-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PATH, Germering, Germany |
| Recall initiated | 2025-11-06 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | WI |
| Countries outside the US | IE |
| UPC / GTIN / UDI-DI | 04260223141355 |
| Serial numbers | 1008852, 1008888, 1008916, 1008925, 1008935, 1008945, 1008951, 1008957, 1008960, 1008962, 1008966, 1008967, 1008987, 1008990, 1009054, 1009065, 1009066, 1009131, 1009137, 1009138, 1009139, 1009145, 1009148, 1009155, 1009159 and 51 more |
| Model numbers | 8-69-41100 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0940-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.