{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "217080",
      "product_res_number": "Z-0958-2026",
      "event_date_initiated": "2025-11-13",
      "event_date_posted": "2025-12-18",
      "recall_status": "Open, Classified",
      "res_event_number": "97904",
      "product_code": "NDC",
      "k_numbers": [
        "K242775"
      ],
      "product_description": "InPen App, Model/CFN Number: MMT-8061 (Android Users)",
      "code_info": "Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596",
      "firm_fei_number": "3003166194",
      "recalling_firm": "Medtronic MiniMed, Inc.",
      "address_1": "18000 Devonshire St",
      "city": "Northridge",
      "state": "CA",
      "postal_code": "91325-1219",
      "additional_info_contact": "Medtronic 24-Hr Technical Support\n800-646-4633",
      "reason_for_recall": "When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.",
      "root_cause_description": "Software Design Change",
      "action": "On 11/13/2025, correction notices were emailed to customers who were asked to update to version 8.0.1 or higher as soon as possible to resolve this issue.\n\n1.Verify your app version:\n-On the home screen, navigate to the Settings menu (lower right corner).\n- Select Help and Support.\n- Note the App Version displayed.\n2. If you are running versions 8.0.0, update to the latest version 8.0.1 or higher via the Google Play Store:\n- Open the Google Play Store.\n- Tap your profile icon at the top of the screen, then select Manage apps & device.\n- Tap Updates available or search for the InPen app.\n- Tap Update next to the InPen app icon.\n\nElectronically acknowledge that you have read and understand this notification and have followed the actions listed\n\nFor questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option #1.\n\nThe Customer Confirmation Form can also be emailed to the firm at rs.safetyinformation@medtronic.com",
      "product_quantity": "8251",
      "distribution_pattern": "US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM.\n\nOUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom",
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        "device_name": "Calculator, Drug Dose",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.1890",
        "device_class": "2"
      }
    }
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}