FDAFDA recall Z-2960-2026 · Aug 26, 2026
Tobii Dynavox Llc: TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 recall
Recall found
Product
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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).
- Distribution
- US Nationwide distribution.
- Recalling firm
- Tobii Dynavox Llc, Pittsburgh, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-08
Source: openFDA enforcement record Z-2960-2026 · search recall number Z-2960-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.