{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217750",
      "product_res_number": "Z-1493-2026",
      "event_date_initiated": "2025-11-27",
      "event_date_posted": "2026-03-05",
      "recall_status": "Open, Classified",
      "res_event_number": "98161",
      "product_code": "MCM",
      "pma_numbers": [
        "P960058S149"
      ],
      "product_description": "Brand Name: HiResolution Bionic Ear System\nProduct Name: Sky CI M90 Sound Processor\nModel/Catalog Number: CI-5295-150",
      "code_info": "Lot Code: UDI-DI: 08400944CI5295YJ\nModel Number: CI-5295-150\nSerial Numbers: 249596, 249603",
      "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": "Michelle Caulfield\n1-661-3621400",
      "reason_for_recall": "Behind-the-ear sound processer  packaging  label is different then included product.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: \n\nConsignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. \n\nAcknowledge receipt and understanding of the recall communication.",
      "product_quantity": "2 units",
      "distribution_pattern": "Unknown",
      "openfda": {
        "pma_number": [
          "P940022",
          "P840024",
          "P890027",
          "P000025",
          "P830069",
          "P960058",
          "P200021",
          "P970051",
          "P000015"
        ],
        "registration_number": [
          "3007743836",
          "3010363503",
          "3002806740",
          "3013177549",
          "3011823740",
          "3014579188",
          "1721676",
          "3008947133",
          "9611813",
          "9613646",
          "9710014",
          "3012654499",
          "3020283264",
          "3009092818",
          "3009762645",
          "3033788852",
          "3005210579",
          "3002808022",
          "3030784382",
          "3005900820",
          "2030624",
          "3034170504",
          "8043792"
        ],
        "fei_number": [
          "3007743836",
          "3002808269",
          "3010363503",
          "3003045432",
          "3002806740",
          "3013177549",
          "3011823740",
          "3000206435",
          "3014579188",
          "1721676",
          "3008947133",
          "3012654499",
          "3009092818",
          "3020283264",
          "3002806685",
          "3033788852",
          "3005210579",
          "3002808022",
          "3030784382",
          "3005900820",
          "3000249315",
          "3034170504",
          "1000220815"
        ],
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}