Recall Z-1950-2026 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
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 Processor
| Date | Apr 27, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 install |
| Quantity | 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 Canad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.