Z-0094-2019Class II

Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10

Name: Z-0094-2019 Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10
Creator: Widex A/S
Published: 2018-08-31
License: https://open.fda.gov/license/

WS Audiology A/S / initiated 2018-08-31 / Terminated / root cause: manufacturing process

FDA source

Widex A/S began a recall of 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... on 2018-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0094-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-31
Posted: 2018-10-10
Terminated: 2018-12-21
Recalling firm: WS Audiology A/S
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.
Product code: ESD Hearing Aid, Air-Conduction, Prescription
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Widex, sent an "Urgent Medical Device Correction Letter" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: a) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted. b) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted. If you have any questions, contact Director, Global Regulatory Affairs at 0045 44 35 57 71 or email to: [email protected].
Quantity in commerce: 2
Distribution: US Distribution to states of: GA and NY.
Product codes and lots: Serial numbers 024569 and 024550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-10

Product code ESD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)