Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Widex BABY hearing aid (referred to as BABY440) Recalled by Widex A/S Due to The reason for this field action is due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Widex A/S directly.
Affected Products
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.
Quantity: 2
Why Was This 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.
Where Was This Sold?
This product was distributed to 2 states: GA, NY
About Widex A/S
Widex A/S has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report