Data Foundry

Medical device recalls 2023

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating… — Class II medical device recall Z-1399-2023

Ongoing recall by Tobii Dynavox Llc, reported 2023-04-26, distributed nationwide. Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Recall numberZ-1399-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmTobii Dynavox Llc, Pittsburgh, PA, United States
Recall initiated2023-02-24
Classified2023-04-18
Reported by FDA2023-04-26
DistributedNationwide (US)
Countries outside the USAE, AR, AU, BE, BR, CA, DE, DK, EE, FI, FR, GB, HR, IE, IS, IT, LV, NL, NO, SA, SE, SI, SK
Quantity3,924 units
UPC / GTIN / UDI-DI07340074601714
Serial numbersTD110-211005000001
Model numbers750567

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1399-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.