{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "183951",
      "product_res_number": "Z-0487-2021",
      "event_date_initiated": "2020-09-26",
      "event_date_posted": "2020-11-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-05-04",
      "res_event_number": "86536",
      "product_code": "MCM",
      "product_description": "AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Nada CI Q90 Sound Processor  (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260). For cochlear implant.",
      "code_info": "410078519",
      "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. Kaitlin Farrell\n661-362-4631",
      "reason_for_recall": "Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 9/26/2020 Advanced Bionics sent a \"Field Correction Notification\" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees.  In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery.",
      "product_quantity": "28 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.",
      "openfda": {
        "pma_number": [
          "P890027",
          "P940022",
          "P970051",
          "P000015",
          "P830069",
          "P200021",
          "P960058",
          "P000025",
          "P840024"
        ],
        "registration_number": [
          "3002808022",
          "3008947133",
          "3012654499",
          "3005210579",
          "3034170504",
          "3010363503",
          "3005900820",
          "3013177549",
          "3009762645",
          "3002806740",
          "3033788852",
          "3011823740",
          "3030784382",
          "3009092818",
          "1721676",
          "9613646",
          "9611813",
          "3014579188",
          "3020283264",
          "2030624",
          "8043792",
          "9710014",
          "3007743836"
        ],
        "fei_number": [
          "3002808269",
          "3002808022",
          "3008947133",
          "3012654499",
          "3005210579",
          "3034170504",
          "3010363503",
          "3005900820",
          "3013177549",
          "3002806740",
          "3033788852",
          "3011823740",
          "1000220815",
          "3002806685",
          "3030784382",
          "3009092818",
          "1721676",
          "3014579188",
          "3000206435",
          "3000249315",
          "3020283264",
          "3007743836",
          "3003045432"
        ],
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}