FDA DeviceClass IINotable

FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Mode

Date: 2026-06-10
Brand: Advanced Bionics, LLC
Category: Medical Device
FDA Class: Class II

Description

Due to incorrect shelf-life expiration date.

Hazard

Due to incorrect shelf-life expiration date.

Remedy

36

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