Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air… — Class II medical device recall Z-1950-2026
Ongoing recall by Advanced Bionics, LLC, reported 2026-05-06, distributed nationwide. The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by
| Recall number | Z-1950-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Bionics, LLC, Valencia, CA, United States |
| Recall initiated | 2026-03-23 |
| Classified | 2026-04-27 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KR, LU, MY, NL, NO, NZ, PL, PT, RO, SA, SE, SG, SI, TH, TT, ZA |
| Quantity | 45,173 |
| Model numbers | CI-5501-110 |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.