Implant, Cochlear

Brand Name: HiResolution" Bionic Ear System

Due to incorrect shelf-life expiration date.

Brand Name: HiResolution" Bionic Ear System

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.

Brand Name: HiResolution Bionic Ear System

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

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

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

Medline Convenience kits, labeled as:

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Mi1250 SYNCHRONY 2, Item Numbers:

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.

Cochlear Nucleus Sterile Silicone Template

Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.