Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor M…
Reason for recall
Behind-the-ear sound processer packaging label is different then included product.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number:CI-5295-150UDI-DI 08400944CI5295YJModel Number4 affected lots08400944CI5295YJCI-5295-150249596249603
What the firm is doing
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.
DistributionShow detailsHide
Unknown
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- 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.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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