FDA Medical devices recall ·
TD Navio Midi Speech Generating Device Model recall
- Recall number
- Z-2959-2026
- Date
- (initiated July 8, 2026)
- Company / brand
- Tobii Dynavox Llc
2100 Wharton St Ste Ste 400, Pittsburgh, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 073400747602056 Serial Numbers TDNM1-240628000004 through TDNM1-260617070001. Corrected/future production is differentiated by new serialization from TDNM1-260617070001 onward (production batch 20260615, improved design).
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2959-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.