Advanced Bionics, LLC recalls
3 recalls.
- Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus... recall (Advanced Bionics, LLC)
Medical deviceClass IIReported June 10, 2026 · Due to incorrect shelf-life expiration date. - Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak ... recall (Advanced Bionics, LLC)
Medical deviceClass IIReported May 6, 2026 · 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... - Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor ... recall (Advanced Bionics, LLC)
Medical deviceClass IIReported March 11, 2026 · Behind-the-ear sound processer packaging label is different then included product.