TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 — Class II medical device recall Z-2959-2026
Ongoing recall by Tobii Dynavox Llc, reported 2026-08-26, distributed nationwide. Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within th
| Recall number | Z-2959-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tobii Dynavox Llc, Pittsburgh, PA, United States |
| Recall initiated | 2026-07-08 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Lot numbers | 20260615 |
| Serial numbers | TDNM1-240628000004 |
| Model numbers | 1000798 |
Product
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Reason for recall
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
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-2959-2026. 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.