Reported May 6, 2026 · Ongoing
Brand Name
Advanced Bionics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics, LLC · 28515 Westinghouse Pl · Valencia, CA · 91355-1398
Is this the product you have?
Brand Name
11 of 11 products
| Model / number | Product as published |
|---|---|
CI-5501-110 | HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/ |
| — | 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 |
- Lot codes and dates
- Lot Code
All lots manufactured up to February 32026. Refer to Exhibit_0006
- Lot Code
- Amount recalled
- 45173
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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