Z-1493-2026Class II

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number...

Name: Z-1493-2026 Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number...
Creator: Advanced Bionics, LLC
Published: 2025-11-27
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2025-11-27 / Open, Classified / root cause: labeling and UDI

FDA source

Advanced Bionics, LLC began a recall of Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 on 2025-11-27. FDA classified it as Class II and gives the reason as "Behind-the-ear sound processer packaging label is different then included product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1493-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-27
Posted: 2026-03-05
Recalling firm: Advanced Bionics LLC
Product: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Product code: MCM Implant, Cochlear
Reason for recall: Behind-the-ear sound processer packaging label is different then included product.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2 units
Distribution: Unknown
Product codes and lots: Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1493-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1493-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-05

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)