Z-1950-2026Class II

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number...

Name: Z-1950-2026 Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number...
Creator: Advanced Bionics, LLC
Published: 2026-03-23
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2026-03-23 / Open, Classified

FDA source

Advanced Bionics, LLC began a recall of 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... on 2026-03-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1950-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-23
Posted: 2026-04-27
Recalling firm: Advanced Bionics LLC
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
Product code: MCM Implant, Cochlear
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.
FDA root cause: Under Investigation by firm
Action: On 03/24/2026, the firm emailed customers an "URGENT: MEDICAL DEVICE RECALL M ZN-AIR BATTERY PAK (CI-5501)" Letter to inform them that, Advanced Bionics is voluntarily recalling the non-tamperproof battery door from the packaged configuration for all M Zn-Air Battery Pak (CI-5501), due to the non-tamperproof battery door does not require the use of a tool to replace the button batteries and therefore could allow unintended access to the button cell batteries within the battery compartment. Customer are instructed to: 1. Identify the Non-Tamperproof Battery Door - confirm which door is installed by performing the following check: -When inserted into the battery cartridge, the non-tamperproof door can be removed without using a tool. -The tamperproof battery door requires a tool for removal once installed. If you must use a tool to remove the door, you have the tamperproof door installed. 2. Remove and Dispose of the Non-Tamperproof Battery Door - Once identified, ensure the non-tamperproof battery door is removed from the battery cartridge. Do not reinstall or use this component. 3. Complete the Acknowledgement & Disposal Form (required) - After disposing of the non-tamperproof battery door, confirm that the component has been removed from service and disposed of appropriately by completing the Acknowledgement & Disposal Form linked in your email. For questions - contact customer service at 1-877-829-0026 or email [email protected]
Quantity in commerce: 45173
Distribution: 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.
Product codes and lots: Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1950-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1950-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-27

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)