Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Nu...
FDA Device Recall #Z-1950-2026 — Class II — March 23, 2026
Recall Summary
| Recall Number | Z-1950-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 23, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Bionics, LLC |
| Location | Valencia, CA |
| Product Type | Devices |
| Quantity | 45173 |
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
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.
Distribution Pattern
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.
Lot / Code Information
Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006
Other Recalls from Advanced Bionics, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2283-2026 | Class II | Brand Name: HiResolution" Bionic Ear System Pr... | Apr 30, 2026 |
| Z-1493-2026 | Class II | Brand Name: HiResolution Bionic Ear System Pro... | Nov 27, 2025 |
| Z-1813-2025 | Class II | HiResolution" Bionic Ear System - M Battery Cha... | Mar 5, 2025 |
| Z-0486-2021 | Class III | AB PowerCel 230 (velvet black), REF: CI-5523-15... | Sep 26, 2020 |
| Z-0487-2021 | Class III | AB PowerCel 170 (velvet black), REF: CI-5517-15... | Sep 26, 2020 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.