Widex BABY hearing aid — Class II medical device recall Z-0094-2019
Terminated recall by Widex A/S, reported 2018-10-17, distributed in GA, NY. The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on
| Recall number | Z-0094-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Widex A/S, Lynge, Denmark |
| Recall initiated | 2018-08-31 |
| Classified | 2018-10-10 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2018-12-21 |
| Distributed | GA, NY |
| Quantity | 2 |
| Serial numbers | 024550, 024569 |
Product
Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
Reason for recall
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
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-0094-2019. 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.