Pittsburgh, PA, United States
Tobii Dynavox Llc recalls
2 recalls recorded since 2018, most recently on 8 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 July 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2959-2026, Z-2960-2026
- TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
- TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Ongoing Class II Medical devices
- Recall started
- 24 February 2023
- Reason
- Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, United Arab Emirates, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1399-2023
- Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.