FDAAugust 31, 2018device
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.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
widex a swidex
Recall history
No related federal recalls on record for this brand yet.
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