{
  "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": "2026-08-15",
    "results": {
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      "product_res_number": "Z-0354-2020",
      "event_date_initiated": "2019-10-01",
      "event_date_created": "2019-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2026-02-10",
      "res_event_number": "83926",
      "product_code": "NDC",
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      "firm_fei_number": "3009864844",
      "recalling_firm": "Monarch Medical Technologies",
      "address_1": "2137 South Blvd Ste 300 2137 South Blvd",
      "address_2": "Ste 300",
      "city": "Charlotte",
      "state": "NC",
      "postal_code": "28203-5189",
      "additional_info_contact": "Bruce Lisante\n855-363-7475",
      "reason_for_recall": "Product was distributed prior to approval or clearance from FDA.",
      "root_cause_description": "Software change control",
      "action": "The firm held meetings and emailed the consignees beginning on 09/27/2019 and followed with a letter.  The notice stated that no medical decision should be based solely on the recommended guidance provided by the software program and requested the facility take additional precautions when following EndoTool SubQ dose recommendations.",
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