Z-1493-2026 Class II Ongoing
FDA device recall Z-1493-2026 was initiated by Advanced Bionics, LLC on November 27, 2025 and is designated Class II. Reason for recall: Behind-the-ear sound processer packaging label is different then included product. The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- November 27, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Reason for Recall
Behind-the-ear sound processer packaging label is different then included product.
Distribution Pattern
Unknown
Code Information
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603