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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The Sky CI M90 is a behind-the-ear sound processor used with cochlear implant systems. Recipients rely on accurate labeling to ensure proper device pairing and function.
Labeling mismatches can lead to incorrect device identification and improper use, potentially affecting device performance.
This recall is not part of a broader industry pattern.
The issue creates immediate use uncertainty for recipients and clinicians. There is potential for disruption in therapy if misidentified devices are used.
Serial numbers and model information are on the device and its packaging. The FDA recall page provides official details.
Refunds or replacements typically take 4-8 weeks after verification and request submission.
Save recall notice, take photos of the packaging label and device, keep serial numbers, and record all correspondence with the manufacturer.
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.
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