FDA recall Z-1493-2026

Product

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Reason for recall

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

Distribution

Unknown

Key facts

Status

Ongoing

Initiation date

2025-11-27

Report date

2026-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1493-2026