Home / Recalls / Medical Devices
Widex A/S recalls Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is inten
Recalled October 17, 2018 · FDA recall Z-0094-2019 · Widex A/S
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. · FDA Class II
Units
2
Sold at
US Distribution to states of: GA and NY.
Description
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.
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.
Manufacturer(s)
Widex A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →