FDAFDA · Food and drugs·Recall number Z-0094-2019
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.
Published October 17, 2018 · Recall initiated: August 31, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Widex A/S
- Distributor
- US Distribution to states of: GA and NY.
- Lot
- Serial numbers 024569 and 024550
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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