{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 16
    }
  },
  "results": [
    {
      "cfres_id": "216879",
      "product_res_number": "Z-1140-2026",
      "event_date_initiated": "2025-10-24",
      "event_date_posted": "2026-01-22",
      "recall_status": "Open, Classified",
      "res_event_number": "97879",
      "product_code": "HGM",
      "k_numbers": [
        "K102140",
        "K173042"
      ],
      "product_description": "Brand Name: EDAN\nProduct Name: Fetal Monitor\nModel/Catalog Number: F2, F3\nProduct Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery.\nComponent: No",
      "code_info": "EDAN Model: F3\nUDI-DI code: 06944413800847\nSerial/Lot 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Model: F2\nUDI-DI code: 06944413800861\nSerial/Lot 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      "firm_fei_number": "3009499478",
      "recalling_firm": "Edan Diagnostics",
      "address_1": "9833 Pacific Heights Blvd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4707",
      "additional_info_contact": "Chao Lin\n858-7503066",
      "reason_for_recall": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
      "root_cause_description": "Device Design",
      "action": "On 10/24/2025, the firm emailed notifying customers of a product recall.  On 11/06/2025, the firm emailed an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration. \n-First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and\nSecond issue involves an inappropriate publicly IP address that was used as the factory default configuration.\n\nCustomer are instructed to:\n1. Immediately examine their inventory and quarantine product subject to correction. \n2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION.\n3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and  Corrigenda of User Manual into its package before distribution.\n4. For affected product that has been distributed or is in use:\n(1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual.\n(2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration.\n5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email.\n\nFor questions - Contact:\nEDAN Instruments, Inc.\nMonday to Friday 09:00-17:00 (UTC+8)\nTel:+86-0755-26898326\nEDAN Diagnostics, Inc.\nMonday to Friday 09:00-17:00 (PST)\nTel: 1-(858)-750-3066",
      "product_quantity": "3721",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.",
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