{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Milwaukee",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86716",
      "recalling_firm": "WELCH ALLYN, INC/MORTARA",
      "address_1": "7865 N 86th St",
      "address_2": "N/A",
      "postal_code": "53224-3431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of  Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.",
      "recall_number": "Z-0553-2021",
      "product_description": "ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.",
      "product_quantity": "1,009 units",
      "reason_for_recall": "The radio within the device can become disassociated with the wireless access point.",
      "recall_initiation_date": "20201111",
      "center_classification_date": "20201209",
      "termination_date": "20230808",
      "report_date": "20201216",
      "code_info": "Part Number           Device Identifier  ELI380-ABS12       00732094265545  ELI380-ABX12       00732094265514  ELI380-ACQ12      00732094319439  ELI380-ACS11       00812345026313  ELI380-ACX11       00812345024531  ELI380-ACX12       00732094265439  ELI380-ACX21       00812345024562  ELI380-ACX22       00732094265422  ELI380-ACX32       00732094265415  ELI380-DAS44       00732094265354  ELI380-DBX12       00732094265286  ELI380-DBX22       00732094265279  ELI380-DCP12       00732094301670  ELI380-DCQ11       00732094307870  ELI380-DCS11       00812345026917  ELI380-DCS12       00732094265248  ELI380-DCS21       00812345026924  ELI380-DCS43       00812345026948  ELI380-DCT12       00732094265217  ELI380-DCX11       00812345026979  ELI380-DCX12       00732094265200  ELI380-DCX21       00812345026986  ELI380-DCX22       00732094265194  ELI380-DCX32       00732094265187  ELI380-DCX43       00812345027006"
    }
  ]
}