# FDA recall Z-0094-2019

> **Widex A/S** · Class II · device recall initiated 2018-08-31.

## 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.

## Distribution

US Distribution to states of: GA and NY.

## Key facts

- **Recall number:** Z-0094-2019
- **Recalling firm:** Widex A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-31
- **Report date:** 2018-10-17
- **Termination date:** 2018-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lynge, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2019

## Citation

> AI Analytics. FDA recall Z-0094-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0094-2019. Source: US FDA. Licensed CC0.

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