{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "219419",
      "product_res_number": "Z-1950-2026",
      "event_date_initiated": "2026-03-23",
      "event_date_posted": "2026-04-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98678",
      "product_code": "MCM",
      "pma_numbers": [
        "P960058"
      ],
      "product_description": "Brand Name: HiResolution\" Bionic Ear System\nProduct Name: M Zn-Air Battery Pak\nModel/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\nSoftware Version: Not Applicable\nProduct 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.  \nThe M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.\nComponent: Not Applicable",
      "code_info": "Lot Code: All lots manufactured up to February 3, 2026.  Refer to Exhibit_0006",
      "firm_fei_number": "1000220815",
      "recalling_firm": "Advanced Bionics, LLC",
      "address_1": "28515 Westinghouse Pl",
      "city": "Valencia",
      "state": "CA",
      "postal_code": "91355-1398",
      "additional_info_contact": "Ms. Michelle Caulfield\n661-362-1400",
      "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.",
      "root_cause_description": "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.\n\nCustomer are instructed to:\n1. Identify the Non-Tamperproof Battery Door - confirm which door is installed by performing the following check:\n-When inserted into the battery cartridge, the non-tamperproof door can be removed without using a tool.\n-The tamperproof battery door requires a tool for removal once installed.\nIf you must use a tool to remove the door, you have the tamperproof door installed.\n2. 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.\n3. 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\nForm linked in your email.\n\nFor questions - contact customer service at 1-877-829-0026 or email customerservice@advancedbionics.com",
      "product_quantity": "45173",
      "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.",
      "openfda": {
        "pma_number": [
          "P000015",
          "P960058",
          "P840024",
          "P970051",
          "P830069",
          "P000025",
          "P890027",
          "P200021",
          "P940022"
        ],
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "2030624",
          "3002808022",
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          "3005900820",
          "3009762645",
          "3008947133",
          "3011823740",
          "3013177549",
          "9613646"
        ],
        "fei_number": [
          "3003045432",
          "3002806685",
          "3002808022",
          "3000206435",
          "3007743836",
          "3005210579",
          "3009092818",
          "1000220815",
          "3033788852",
          "3012654499",
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          "3034170504",
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        ]
      }
    }
  ]
}