Widex A/S: Medical Device Recall in 2018 - (Recall #: Z-0094-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 31, 2018

Date Posted: October 17, 2018

Recall Number: Z-0094-2019

Event ID: 81085

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2

Code Information:

Serial numbers 024569 and 024550

Distribution Pattern:

US Distribution to states of: GA and NY.

Voluntary or Mandated:

Voluntary: Firm initiated