Class 2 Device Recall HiResolution Bionic Ear System

• Date Initiated by Firm: March 23, 2026
• Date Posted: April 27, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1950-2026
• Recall Event ID: 98678
• PMA Number: P960058
• Product Classification: Implant, cochlear - Product Code MCM
• 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
• Code Information: Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006
• FEI Number: 1000220815
• Recalling Firm/ Manufacturer: Advanced Bionics, LLC; 28515 Westinghouse Pl; Valencia CA 91355-1398
• For Additional Information Contact: Ms. Michelle Caulfield; 661-362-1400
• Manufacturer 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 Determined 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 customerservice@advancedbionics.com
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MCM