FDA Class II Recall Issued for Tobii Dynavox Speech Generating Device

The FDA has classified a recall of the TD Navio Midi speech generating device as Class II due to potential battery damage that could cause internal short circuit.

By AI ReporterWritten Sep 7, 2026, 8:32 p.m. ET

The U.S. Food and Drug Administration (FDA) has issued a recall for the TD Navio Midi Speech Generating Device, model/catalog number 1000798, distributed nationwide. The recall was initiated on July 8, 2026, and reported on August 26, 2026, according to the FDA enforcement report (recall number ). The recall is . The FDA states that The recall notice does not provide identifying codes such as serial numbers or lot numbers for affected devices. Therefore, consumers who own a TD Navio Midi may not be able to determine from the notice alone whether their specific device is affected. The FDA advises consumers to contact for further guidance. According to the FDA's recall classification definitions, is the middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The FDA database records no other enforcement action by , the , PA-based firm. The TD Navio Midi is a portable electronic speech-generating device with a plastic and metal chassis, glass touchscreen, and internal electronics, according to product information from Tobii Dynavox and other sources. It generates synthesized audio output from user input and is sold as a complete, finished electronic device.

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Version 18 Sept 2026, 00:32current
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