FDA recall, , Moderate risk
Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device
The TD Navio Midi Speech Generating Device may have damaged battery mounting tabs, causing internal short circuit and heating.
Summary by Recall Canary from the FDA notice
What happened
Tobii Dynavox Llc of Pittsburgh, Pennsylvania recalled the TD Navio Maxi and TD Navio Midi Speech Generating Devices on July 8, 2026. 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. The recall was added to the FDA's Enforcement Report on August 14, 2026, and distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and catalog code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
TD Navio Maxi Speech Generating Device Model/
- UDI-DI
- 240904000016
- 260617070001
- 20260615
- Catalog code
- 1000799
TD Navio Midi Speech Generating Device Model/
- UDI-DI
- 240628000004
- 260617070001
- 20260615
- Catalog code
- 1000798
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Tobii Dynavox LlcPittsburgh, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99410
- Recall numbers
- Z-2959-2026 to Z-2960-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
