← FDA ENFORCEMENT
Z-2960-2026Class II

Tobii Dynavox Llc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Tobii Dynavox Llc
Product type
Device
Status
Ongoing
Report date
2026-08-26
Distribution
US Nationwide distribution.
Firm state
PA
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

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).

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →