Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Recalled by Advanced Bionics, LLC Due to Three materials used in the makeup of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Bionics, LLC directly.
Affected Products
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Quantity: 4
Why Was This Recalled?
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Where Was This Sold?
No US distribution OUS: Japan
About Advanced Bionics, LLC
Advanced Bionics, LLC has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report