Advanced Bionics recalls HiRes 90K Advantage CI HiFocus MS Electrode cochlear implants due to missing bio-compatible materials in Japan's PMDA submission. Not distributed in the US.
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.
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Contact the company
📍Recalling firmAdvanced Bionics, LLC28515 Westinghouse Pl · Valencia, CA 91355-1398
“Advanced Bionics HiRes 90K Cochlear Implant Recall: Missing Bio-Compatible Materials.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68610-advanced-bionics-hires-90k-cochlear-implant-recall-missing-bio-compatible. Based on FDA recall #Z-1259-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1259-2020%22&limit=1).
The Food and Drug Administration announced on March 18, 2019, that Advanced Bionics, LLC voluntarily recalled the HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. The hazard involves three materials used in the implant being mistakenly omitted from the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
How to tell if you have it
Brand: Advanced Bionics
Product: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
UPC: 07630016832185
Distribution: Not distributed within the US; OUS: Japan
The hazard
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.
Context
GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since February 6, 2019. Other recent recalls include a HiResolution Bionic Ear System recall for an incorrect shelf-life expiration date (April 30, 2026), a HiResolution Bionic Ear System Battery Pak recall for a non-tamperproof door (March 23, 2026), and a HiResolution Sky CI M90 Sound Processor recall for a packaging label mismatch (November 27, 2025). Other recent recalls of similar products include a Medtronic Bio-Medicus Adult Cannula Kit recall for loose foreign material risk (May 25, 2026), a Silent Nite Sleep Appliance recall for missing FDA clearance (April 27, 2026), and a Zeiss Intrabeam Spherical Applicator 1.5 cm recall for a manufacturing defect (June 1, 2026).
How to tell if you have this one
Check for the model 'HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04' on the implant. The product was not distributed within the US, so US users are not affected.
Brand
Advanced Bionics
Product
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number on your implant to confirm if it matches 'HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04'.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1259-2020 (March 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1259-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.