Recall
Class II — PATH
| Recalling firm | PATH |
|---|---|
| Registered facility | PATH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Affected lots of product may experience technical distortions to a greater extent than expected. |
| Product | SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2 |
| Quantity | 28 units |
| Distribution | US States: FL, MO, OH, WI |
| Initiated | 2023-09-26 |
| Classified | 2023-11-24 |
| Recall number | Z-0402-2024 |
| 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-0402-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93275/
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