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Open, Classified

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

FDA Recall Z-2960-2026 · Posted 2026-08-14

Recalling FirmTobii Dynavox Llc
Recall StatusOpen, Classified
Product CodeILQ
Date Initiated2026-07-08

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.

Firm Action

On July 8, 2026, the firm notified customers by emailing letters titled "URGENT: MEDICAL DEVICE RECALL NOTICE." Customers were informed that Tobii Dynavox would provide a repair authorization number (RA#), prepaid shipping label, inspection, repair, and return shipping for the affected device. The repair will include modifications intended to improve battery stability within the device. Customers were provided with ways to contact the company to obtain a repair authorization number. Customers were informed that it is safe to continue using the device as intended while waiting for the repair, as long as there are no signs of overheating, swelling, unusual odor, smoke, deformation, or battery abnormality. If any of these conditions are observed, discontinue use immediately and contact Tobbi Dynavox.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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