medical Class II Updated 2018-10-17

Widex A/S recalls Widex BABY hearing aid (referred to as BABY440), powered by

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Affected States: GA, NY
Lot/Code Info: Serial numbers 024569 and 024550
View official government recall

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