Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-550

FDA device recall Z-1950-2026 · posted 2026-04-27 · Open, Classified

Recall details

Recalling firm

Advanced Bionics, LLC

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MCM

Quantity affected

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

Date initiated

2026-03-23

Date posted

2026-04-27

Location

Valencia, CA