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Open, Classified

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

FDA Recall Z-1493-2026 · Posted 2026-03-05

Recalling FirmAdvanced Bionics, LLC
Recall StatusOpen, Classified
Product CodeMCM
Date Initiated2025-11-27
Product Quantity2 units

Reason for Recall

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

Firm Action

On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: Consignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. Acknowledge receipt and understanding of the recall communication.

Root Cause

Under Investigation by firm

Distribution Pattern

Unknown

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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