Advanced Bionics recalled 2 Sky CI M90 behind-the-ear sound processors on 2025-11-27. The packaging label does not match the included product. Consumers should stop using the device and follow manufacturer instructions.
Behind-the-ear sound processer packaging label is different then included product.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Advanced Bionics, LLC or your healthcare provider for instructions. Notification method: Letter
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Brand/Manufacturer: Advanced Bionics. Product: Sky CI M90 behind-the-ear sound processor. Model/Catalog Number: CI-5295-150. Lot/UDI: UDI-DI 08400944CI5295YJ. Serial Numbers: 249596, 249603. Quantity recalled: 2 units. Distribution: Unknown. Sold/When Sold: Unknown. Recalled by: FDA enforcement action. Recall date: 2025-11-27.
The behind-the-ear sound processor packaging label is different from the product inside. This labeling discrepancy could lead to incorrect product identification or use.
1. Stop using the product immediately. 2. Contact Advanced Bionics or your healthcare provider for instructions. 3. Follow the recall instructions provided by the manufacturer. 4. Await further guidance on refunds or replacements from Advanced Bionics. 5. Do not attempt to modify or repack the device.
Manufacturer: Advanced Bionics, LLC. Public contact details not provided in the recall notice. For official information, see the FDA recall page at the provided link. Healthcare providers can advise on interim steps.
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