{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97662",
      "recalling_firm": "Tandem Diabetes Care, Inc.",
      "address_1": "12400 High Bluff Dr",
      "address_2": "N/A",
      "postal_code": "92130-3077",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY",
      "recall_number": "Z-0427-2026",
      "product_description": "Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin 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).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081",
      "product_quantity": "17,745",
      "reason_for_recall": "Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: \"Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped\", which could result in hyperglycemia.",
      "recall_initiation_date": "20251006",
      "center_classification_date": "20251105",
      "report_date": "20251112",
      "code_info": "Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170",
      "more_code_info": ""
    }
  ]
}