HiResolution recalls M Zn-Air Battery Paks (models CI-5501-110 to CI-5501-280) due to non-tamperproof battery door that may not require tool to replace battery, risking improper installation.
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
HiResolution is recalling M Zn-Air Battery Paks for cochlear implants because the non-tamperproof battery door might not need a tool to replace the battery. This could lead to improper installation if users try to replace the battery without the correct tool.
The battery door doesn't require a tool to replace the button/coin cell battery as per IEC 60601-1-11:2015 standards. This means users might not use the correct tool, leading to improper installation and potential damage to the device.
People with cochlear implants using the recalled M Zn-Air Battery Paks (models CI-5501-110 to CI-5501-280) are affected. Those who have the battery paks with non-tamperproof cartridges are most at risk.
Check for the model numbers CI-5501-110 through CI-5501-280 on the battery pack. The product is sold with non-tamperproof cartridges and was manufactured up to February 3, 2026.
Identify the model number on the battery pack to confirm if it's in the recalled range (CI-5501-110 to CI-5501-280).
If you have a recalled battery pack, use the proper tool to replace the battery to ensure safe installation.
The recalled models are CI-5501-110 through CI-5501-280.
The non-tamperproof battery door may not require a tool to replace the battery, which could lead to improper installation if users don't use the correct tool.
No, but you should use the correct tool to replace the battery to avoid improper installation.
We’ve drafted a message you can send HiResolution to request your refund or repair — edit it as you like.
Subject: Recall Z-1950-2026 — HiResolution HiResolution Hello, I own a HiResolution that is covered by recall Z-1950-2026 from HiResolution. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
