CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled

Advanced Bionics is recalling HiResolution" Bionic Ear System M Zn-Air Battery Pak, distributed nationwide in the US. The recall was initiated on 23 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

Quantity recalled45173

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1950-2026
FDA event ID: 98678
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2026
FDA classified: 27 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Hearing Aids

Timeline

23 Mar 2026	Recall initiated by company
27 Apr 2026	Classified by FDA	+35 days
6 May 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Is HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled?

Yes. Advanced Bionics recalled HiResolution" Bionic Ear System M Zn-Air Battery Pak on 23 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1950-2026.

Why was it 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.

Which lots are affected?

Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Advanced Bionics

All 14

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled	Advanced Bionics	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled	Advanced Bionics	Packaging Defects	CA
28 May 2025Device	CLASS II	HiResolution" Bionic Ear System - M Battery Charger recalled	Advanced Bionics	Packaging Defects	6 states
2 Dec 2020Device	CLASS III	AB PowerCel 230 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide
2 Dec 2020Device	CLASS III	AB PowerCel 170 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide

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