Advanced Bionics, LLC is recalling 45,173 HiResolution Bionic Ear M Zn-Air Battery Paks, which are disposable power sources for Naida CI M and Sky CI M Sound Processors. The battery door on these units is not tamperproof and can be opened without a tool, which fails to meet international safety standards for medical electrical equipment used in the home. There have been no reported incidents or injuries at this time. Consumers should identify if they have affected units by checking the catalog and lot numbers printed on the packaging.
The battery door can be opened by hand without a special tool, providing easy access to the button or coin cell batteries. If a child or vulnerable adult accesses and swallows these batteries, it can lead to severe internal chemical burns, tissue damage, or death within hours.
Refer to Exhibit_0006 for full list of lot codes. Designed for use with Naida CI M and Sky CI M Sound Processors using P675 batteries.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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