Brand Name: HiResolution Bionic Ear System Product recall
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Why was Brand Name: HiResolution Bionic Ear System Product recalled?
Behind-the-ear sound processer packaging label is different then included product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603
- Product
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
- Recalling firm
- Advanced Bionics, LLC
- Quantity
- 2 units
- Distribution
- Unknown
- Recall date
- March 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)