FDA recall record · openFDA

Advanced Bionics, LLC

4 FDA recalls on record (2025–2026) — 4 device. 4 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended produ 1

Due to incorrect shelf-life expiration date. 1

The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requir 1

Behind-the-ear sound processer packaging label is different then included product. 1

Recalls

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI Class II 2026-04-30 Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5 Class II 2026-03-23 HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Class II 2025-03-05 Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 Class II 2025-11-27

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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