Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor M…

Behind-the-ear sound processer packaging label is different then included product.

On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: Consignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. Acknowledge receipt and understanding of the recall communication.

• FDA enforcement recordOfficial FDA database entry for Z-1493-2026
• FDA device classification · MCMOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Advanced Bionics, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.