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RecallsAboutBlog

Advanced Bionics, LLC

Advanced Bionics, LLC: 3 recalls listed since March 2026 across FDA.

By year

  • 20263

By agency

  • FDA3

By category

  • Medical Device3

All recalls (3)

Advanced Bionics HiResolution Bionic Ear System Cochlear Implants

The HiResolution Bionic Ear System has an incorrect shelf-life expiration date.

Moderate risk, FDA, , Labeling error

HiResolution Bionic Ear System M Zn-Air Battery Pak

The M Zn-Air Battery Pak has a battery door that does not require a tool to replace the button/coin cell battery.

Moderate risk, FDA, , Device defect

Advanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor

The Sky CI M90 Sound Processor has a packaging label that differs from the included product.

Moderate risk, FDA, , Labeling error
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