{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Saint Paul",
      "address_1": "5000 Township Parkway",
      "reason_for_recall": "Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.",
      "address_2": "",
      "product_quantity": "44",
      "code_info": "Lot#  EMC0004011  EMC0004665  EMC0004114  EMC0004356  EMC0004639  EMC0004399  EMC0004922  EMC0004923  EMC0004989  EMC0004126  EMC0004310  EMC0004724  EMC0004967  EMC0004759  EMC0004235  EMC0004929  EMC0004234  EMC0004965  EMC0004932  EMC0004928  EMC0004969  EMC0004930  EMC0004844  EMC0004053      Lot#  EMC0003968  EMC0003985  EMC0003935  EMC0004028  EMC0004027  EMC0004376  EMC0004125  EMC0004303  EMC0004196  EMC0003852  EMC0004191  EMC0004286  EMC0004491  EMC0004594  EMC0004757  EMC0004510      Lot#  EMC0004304  EMC0004797        Lot#  EMC0003827  EMC0004233",
      "center_classification_date": "20130130",
      "distribution_pattern": "Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.",
      "state": "MN",
      "product_description": "Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System.        The ISA and Commander are software packages that run on a laptop personal computer.",
      "report_date": "20130206",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Envoy Medical Corporation",
      "recall_number": "Z-0750-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63875",
      "termination_date": "20130409",
      "more_code_info": "",
      "recall_initiation_date": "20130109",
      "postal_code": "55110",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}