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Advanced Bionics Recalls

3 recalls found for Advanced Bionics. Check current safety alerts and related brands before using affected products.

Active recalls: 3
Pages: 1

HIGH

FDA DEVICE

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic...

Due to incorrect shelf-life expiration date.

Apr 30, 2026

Advanced Bionics

Due to

HIGH

FDA DEVICE

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240;...

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 button/coin cell battery.

Mar 23, 2026

Advanced Bionics

The non-tamperproof

Health & Personal Care

HIGH

FDA DEVICE

Advanced Bionics Sky CI M90 Recall: 2 Units Over Packaging Label Mismatch (2025)

Advanced Bionics recalled 2 Sky CI M90 behind-the-ear sound processors on 2025-11-27. The packaging label does not match the included product. Consumers should stop using the device and follow manufacturer instructions.

Nov 27, 2025

Advanced Bionics

Behind-the-ear sound

Brand Statistics

Total Recalls

Pages

Advanced Bionics Recalls

Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic...

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240;...

Advanced Bionics Sky CI M90 Recall: 2 Units Over Packaging Label Mismatch (2025)

Brand Statistics

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