Dynavox T15 Speech Generating Device — Class II medical device recall Z-1305-2018
Terminated recall by Dynavox Systems Llc, reported 2018-04-11. The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of ti
| Recall number | Z-1305-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynavox Systems Llc, Pittsburgh, PA, United States |
| Recall initiated | 2017-12-14 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-12-11 |
| Quantity | 307 |
| Model numbers | 750423, T15 |
Product
Dynavox T15 Speech Generating Device ( including Batteries)
Reason for recall
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
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-1305-2018. 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.