Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI Recalled by Advanced Bionics, LLC Due to Behind-the-ear sound processer packaging label is different then...

Date: November 27, 2025
Company: Advanced Bionics, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Bionics, LLC directly.

Affected Products

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Quantity: 2 units

Why Was This Recalled?

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

Where Was This Sold?

Unknown

About Advanced Bionics, LLC

Advanced Bionics, LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report