CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

TD I-110 Speech Device-tablet style speech generating recalled

Tobii Dynavox is recalling TD I-110 Speech Device-tablet style speech generating device used for ambulatory people, distributed nationwide in the US. The recall was initiated on 24 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

Quantity recalled3924 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1399-2023
FDA event ID: 91884
Recalling firm: Tobii Dynavox, Pittsburgh, PA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Feb 2023
FDA classified: 18 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Feb 2023	Recall initiated by company
18 Apr 2023	Classified by FDA	+53 days
26 Apr 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Which lots are affected?

UDI: 7340074601714 Serial Numbers: TD110-211005000001 through TD110-220927004400

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Tobii Dynavox

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26 Aug 2026Device	CLASS II	TD Navio Midi Speech Generating Device recalled by Tobii Dynavox	Tobii Dynavox	Device Malfunction	Nationwide

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