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MEDICAL DEVICE RECALLMODERATE
HiResolution Bionic Ear System
Advanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.
What to do
Contact your healthcare provider or Advanced Bionics to verify the correct expiration date and ensure the device is safe for implantation.
Why it was recalled
Due to incorrect shelf-life expiration date.
How to identify it
Brand Name: HiResolution" Bionic Ear System
Official source
Other recent recalls from Advanced Bionics, LLC
Editorial summary by Recall Canary · last updated 2026-06-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification