FDAClass II · Medical device · Recall Z-2960-2026 · Recalled August 26, 2026

TD Navio Maxi Speech Generating Device Model/Catalog Number recall — Tobii Dynavox Llc

Agency report date: August 26, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: TD Navio Maxi Speech Generating Device Model/Catalog Number
Company / brand: Tobii Dynavox
Lot / serial / date codes: UDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).
Distribution: US Nationwide distribution.

Agency product description and boundaries

TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: TD Navio Maxi Speech Generating Device Model/Catalog Number recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2960-2026
Brand: All Tobii Dynavox recalls
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

TD Navio Maxi Speech Generating Device Model/Catalog Number recall status

Companies & origin

Recalling firm location: Pittsburgh, PA, United States
Firm address: 2100 Wharton St Ste Ste 400, 15203-1691

Identifying details (verbatim from the notice)

Product codes / lots: UDI-DI 073400747602070 Serial Numbers TDNL1-240904000016 through TDNL1-260617070001. Corrected/future production is differentiated by new serialization from TDNL1-260617070001 onward (production batch 20260615, improved design).
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 99410
Recall initiated: July 8, 2026
FDA classified: August 14, 2026
FDA report date: August 26, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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