{
  "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": "2026-04-08",
    "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": "87305",
      "recalling_firm": "Insulet Corporation",
      "address_1": "100 Nagog Park",
      "address_2": "",
      "postal_code": "01720-3440",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland",
      "recall_number": "Z-1203-2021",
      "product_description": "Omnipod DASH Insulin Management System User Guide (OUS  Only)  Product Catalog Number:   PT 000002 XXX XXX XX  PT 000318  PT 000319    Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland",
      "product_quantity": "21,723 guides",
      "reason_for_recall": "Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia.  Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended",
      "recall_initiation_date": "20210201",
      "center_classification_date": "20210310",
      "termination_date": "20230208",
      "report_date": "20210317",
      "code_info": "Part Number/Rev./Country:  PT 000002 AUT DEU mg 1, 2, 3 Guide, Dash User, German Austria  PT 000002 BEL DEU MG 1, 2, 3 Guide, Dash User Guide, Belgium   Germany, mgdl  PT 000002 BEL FRE MG 1, 2, 3, 4 Guide, Dash User Guide, Belgium French,  mgdl  PT 000002 BEL NLD MG 1, 2, 3 Guide, Dash User Guide, Belgium Dutch,  mgdl  PT 000002 DEU DEU mg 1, 2, 3 Guide, Dash User Guide, German   Germany, mgdl  PT 000002 DEU DEU mm 1, 2, 3 Guide, Dash User Guide, German   Germany, mmoll  PT 000002 DNK DANmm 1, 2, 3 Guide, Dash User Guide, Danish Denmark  PT 000002 FIN FIN mm 1, 2, 3 Guide, Dash User Guide, Finnish Finland  PT 000002 FRA FRE mg 1, 2, 3, 4 Guide, Dash User Guide, French France  PT 000002 NLD NLD mm 1, 2, 3, 4 Guide, Dash User Guide, Dutch   Netherland  PT 000002 NOR NORmm 1, 2, 3 Guide, Dash User Guide, Norwegian   Norway  PT 000002 SWE SWEmm 1, 2, 3 Guide, Dash User Guide, Swedish Sweden  41333 CAN 1, 2 User Guide, Omnipod, Dash, Canada  PT 000318 1, 2 Guide, Dash User Guide, Greece  PT 000319 1, 2 Guide, Dash User Guide, Turkey",
      "more_code_info": ""
    }
  ]
}