Widex A/S recalls Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intende…

Recall date

August 31, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0094-2019

FDA classification

Class II

Brand / firm

Widex A/S

Sold / distributed

US Distribution to states of: GA and NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.