Device recall

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

FDA recall source

Recall number

Z-2959-2026

Event id

99410

Status

Ongoing

FDA classification

Class II

Recalling firm

Tobii Dynavox Llc

Report date

Aug 26, 2026

Initiated

Jul 8, 2026

Center classification date

Aug 14, 2026

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.

Code info

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).

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States