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MEDICAL DEVICE RECALLMODERATE
HiResolution Bionic Ear System 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
Contact Advanced Bionics or your healthcare provider to receive a replacement battery door that requires a tool for battery replacement.
Why it was recalled
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.
Where it was sold
Distributed in US.
Official source
Other recent recalls from Advanced Bionics, LLC
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification