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Brand Name: HiResolution" Bionic Ear System recallZ-1950-2026 · Advanced Bionics, LLC · initiated Mar 23, 2026

Class II Open, Classified All recalls posted in April 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Bionics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-1950-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Mar 23, 2026
Posted by the FDA
Apr 27, 2026
Recalling firm
Advanced Bionics, LLC
Quantity
45173
Product code
MCM
FDA submissions
P960058
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 description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

25 devices cleared under P960058 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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