FDA recall Z-1813-2025

Advanced Bionics, LLC · Class II · device

Product

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Reason for recall

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Distribution

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Key facts

Status
Ongoing
Initiation date
2025-03-05
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2025