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Class IIOngoing

Tobii Dynavox Llc recalls 2 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Tobii Dynavox Llc
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99410…

Products (2)

  1. TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

    Codes/lots: UDI-DI 073400747602056 Serial Numbers TDNM1-240628000004 through TDNM1-260617070001. Corrected/future production is differentiated by new serialization from TDNM1-260617070001 onward (production batch 20260615, improved design).Recall no. Z-2959-2026Class II

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

    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).Recall no. Z-2960-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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