{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98478",
      "recalling_firm": "Tandem Diabetes Care, Inc.",
      "address_1": "12400 High Bluff Dr",
      "address_2": "",
      "postal_code": "92130-3077",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International distribution in the countries of Czech Republic, Slovakia.",
      "recall_number": "Z-1636-2026",
      "product_description": "Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).",
      "product_quantity": "1,380 units",
      "reason_for_recall": "The Czech language user guide contained multiple translation errors.  The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.",
      "recall_initiation_date": "20260130",
      "center_classification_date": "20260325",
      "report_date": "20260401",
      "code_info": "Version 7.8.1/ UDI: (01)008500066132625",
      "more_code_info": ""
    }
  ]
}