{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216042",
      "product_res_number": "Z-0132-2026",
      "event_date_initiated": "2025-09-11",
      "event_date_posted": "2025-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97597",
      "product_code": "QRX",
      "k_numbers": [
        "K231826"
      ],
      "product_description": "The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.",
      "code_info": "Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.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": "The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.",
      "root_cause_description": "Software design",
      "action": "Insulet notified both healthcare professionals and users on about 09/11/2025 via URGENT: Medical Device Correction letter. Instructions included that an update to the application will be pushed to all devices and should be implemented by users. Users were also requested to confirm receipt and acknowledgement of the notification but selecting the \"acknowledgement button\" in the email.",
      "product_quantity": "174,013 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K231824",
          "K252818",
          "K222888",
          "K203772",
          "K222239"
        ],
        "registration_number": [
          "3004753838",
          "3014585508"
        ],
        "fei_number": [
          "3004753838",
          "3014585508"
        ],
        "device_name": "Continuous Glucose Monitor Informed Insulin Dose Calculator",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1358",
        "device_class": "2"
      }
    }
  ]
}