{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Acton",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85552",
      "recalling_firm": "Insulet Corporation",
      "address_1": "100 Nagog Park",
      "address_2": "N/A",
      "postal_code": "01720-3440",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "The products were distributed to the following foreign countries:  Italy, Netherlands, UK.",
      "recall_number": "Z-2164-2020",
      "product_description": "Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010  M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.",
      "product_quantity": "400",
      "reason_for_recall": "After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.",
      "recall_initiation_date": "20200402",
      "center_classification_date": "20200529",
      "termination_date": "20210914",
      "report_date": "20200610",
      "code_info": "UDI: PT - 000010 - 10385082000139;  Lot Numbers: L000202"
    }
  ]
}