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HiResolution Bionic Ear M Zn-Air Battery Pak
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MEDICAL DEVICE RECALLMODERATE

HiResolution Bionic Ear M Zn-Air Battery Pak

Advanced Bionics is recalling M Zn-Air Battery Paks for sound processors due to a non-compliant battery door design.

What to do

Stop using the non-tamperproof battery door immediately and contact Advanced Bionics for a replacement tamperproof battery door.

Recalled
Listed
Updated
Recall No.
Z-1950-2026
Agency
FDA
Firm
Advanced Bionics, LLC
Recall ID
98678
Status
ONGOING

Why it was recalled

Advanced Bionics is recalling the M Zn-Air Battery Pak for Naida CI M and Sky CI M sound processors because the non-tamperproof battery door does not require a tool to replace the button cell battery, failing to meet safety standards for battery accessibility. This recall was distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

HiResolution" Bionic Ear System M Zn-Air Battery Pak

Model/Catalog number
CI-5501-110, CI-5501-120, CI-5501-130, CI-5501-140, CI-5501-150, CI-5501-190, CI-5501-240, CI-5501-250, CI-5501-260, CI-5501-270, CI-5501-280

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Advanced Bionics, LLC

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification