Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
FDA device recall Z-1493-2026 · posted 2026-03-05 · Open, Classified
Recall details
- Recalling firm
- Advanced Bionics, LLC
- Reason for recall
- Behind-the-ear sound processer packaging label is different then included product.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MCM
- Quantity affected
- 2 units
- Distribution
- Unknown
- Date initiated
- 2025-11-27
- Date posted
- 2026-03-05
- Location
- Valencia, CA
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