Recall Z-1950-2026— Advanced Bionics, LLC

Class II FDA medical device recall by Advanced Bionics, LLC, initiated 2026-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable. Reason: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery..

Recalling firm

Advanced Bionics, LLC

Classification

Class II

Status

Ongoing

Initiated

2026-03-23

Firm location

Valencia, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.