medical MODERATE Updated 2026-05-06

Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M

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Recalled 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

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for Brand Name: HiResolution" Bionic →

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