Advanced Bionics Recalls Sky CI M90 Sound Processors Due to Labeling Error
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Advanced Bionics, LLC has issued a voluntary recall for two Sky CI M90 Sound Processors because the packaging label does not match the product inside.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Advanced Bionics, LLC has initiated a voluntary Class II recall of specific units of its HiResolution Bionic Ear System. The recall was prompted by a labeling error where the packaging label for the behind-the-ear sound processor does not match the actual product contained within the package.
Which Products Are Affected
The recall specifically impacts the Sky CI M90 Sound Processor. Only two units are affected by this specific event.
- Brand Name: HiResolution Bionic Ear System
- Product Name: Sky CI M90 Sound Processor
- Model/Catalog Number: CI-5295-150
- UDI-DI: 08400944CI5295YJ
- Serial Numbers: 249596, 249603
- Recall Number: Z-1493-2026
What You Should Do
Advanced Bionics notified affected parties via a formal letter initiated on November 27, 2025. Consumers or healthcare providers in possession of these specific serial numbers should follow the instructions provided in the firm's notification. For additional information, the recalling firm is located in Valencia, California.
Why This Matters
Accurate labeling is essential for medical devices to ensure that patients and clinicians are using the correct equipment as intended. A mismatch between the packaging and the device can lead to confusion regarding device specifications or compatibility.
Source
Information provided by the FDA under recall event ID 98161.
Original source: FDA Official Notice ↗
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