Advanced Bionics Recalls Sky CI M90 Sound Processors Due to Labeling Error
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 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.
Source: FDA Official Notice
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