Reported Oct 17, 2018 · Terminated

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

Widex A/S

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Widex A/S · Nymollevej 6 · Lynge · N/A

Is this the product you have?

  • Widex BABY hearing aid (referred to as BABY440), powered by
  • zinc-air batteries size 10 Intended useBABY440 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
Lot codes and dates
  • Serial numbers 024569 and 024550
Amount recalled
2

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 21, 2018 · Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.