{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214077",
      "product_res_number": "Z-2016-2025",
      "event_date_initiated": "2025-05-23",
      "event_date_posted": "2025-06-24",
      "recall_status": "Open, Classified",
      "res_event_number": "96945",
      "product_code": "QRX",
      "k_numbers": [
        "K231826"
      ],
      "product_description": "Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP.\n\n\n\nSoftware Version: all\nProduct Description: The Omnipod 5 iOS App software is available to download \nthrough the Apple app store. \n\nThe Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.",
      "code_info": "Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X",
      "firm_fei_number": "3014585508",
      "recalling_firm": "Insulet Corporation",
      "address_1": "50 & 100 Nagog Park",
      "city": "Acton",
      "state": "MA",
      "postal_code": "01720-3440",
      "additional_info_contact": "Angela Geryak Wiczek\n978-600-7451",
      "reason_for_recall": "Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.",
      "root_cause_description": "Software design",
      "action": "Insulet notified health care professionals and users on 05/23/2025 via emailed letter. Consignees were instructed to make sure your phone s keyboard and region\nsettings match the approved country for use   currently, the U.S. only and this issue does not affect the Insulet-provided Omnipod 5 Controllers or the Omnipod 5 App on compatible Android phones.  A software update will be pushed to all devices in the coming weeks, and each consignee will be notified via email and in-app notification on the device when it is ready to install.  The fix will allow commas to be recognized as decimal points when using the Omnipod 5 App for iPhone.  The email notification to users included a section to formally acknowledge the notification.",
      "product_quantity": "122,823 downloads",
      "distribution_pattern": "US market only- Although there are 122823 downloads of the application, our data shows there are only\n~80k active users.",
      "openfda": {
        "k_number": [
          "K231824",
          "K260062",
          "K252818",
          "K222888",
          "K203772",
          "K222239"
        ],
        "registration_number": [
          "3014585508",
          "3004753838"
        ],
        "fei_number": [
          "3014585508",
          "3004753838"
        ],
        "device_name": "Continuous Glucose Monitor Informed Insulin Dose Calculator",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1358",
        "device_class": "2"
      }
    }
  ]
}