SENTIERO SCREENING — Class II medical device recall Z-0404-2024
Ongoing recall by PATH, reported 2023-12-06, distributed in FL, MO, OH, WI. Affected lots of product may experience technical distortions to a greater extent than expected.
| Recall number | Z-0404-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PATH, Germering, Germany |
| Recall initiated | 2023-09-26 |
| Classified | 2023-11-24 |
| Reported by FDA | 2023-12-06 |
| Distributed | FL, MO, OH, WI |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 04260223142475 |
| Serial numbers | 280117 |
| Model numbers | 100098-S, SOH100098 |
Product
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Reason for recall
Affected lots of product may experience technical distortions to a greater extent than expected.
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-0404-2024. 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.