Recall Z-2960-2026
Tobii Dynavox Llc · initiated July 8, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2960-2026
- Initiated
- July 8, 2026
- Posted by FDA
- August 14, 2026
- Product code
- ILQ – System, Communication, Powered
- Distribution
- US Nationwide distribution.
- Recalling firm
- Tobii Dynavox Llc, Pittsburgh, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2959-2026 Class II | TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within… | 07/08/2026Open, Classified |