{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219078",
      "product_res_number": "Z-1631-2026",
      "event_date_initiated": "2026-03-04",
      "event_date_posted": "2026-03-24",
      "recall_status": "Open, Classified",
      "res_event_number": "98556",
      "product_code": "DPW",
      "k_numbers": [
        "K954397"
      ],
      "product_description": "Brand Name: BiDop 3\nProduct Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe\nModel/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe).\nSoftware Version: N/A\nProduct Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.",
      "code_info": "Lot Code: BIDOP 3                #00894912002043\n\n          BT2M20S8C          #00894912002326",
      "firm_fei_number": "1937397",
      "recalling_firm": "Koven Technology, Inc.",
      "address_1": "477 N Lindbergh Blvd Ste 220 477 N Lindbergh Blvd",
      "address_2": "Ste 220",
      "city": "Saint Louis",
      "state": "MO",
      "postal_code": "63141-7856",
      "additional_info_contact": "Heather Bell\n001-800-5218342",
      "reason_for_recall": "Product labeling includes a fetal indication for use that is not cleared under its 510(k).",
      "root_cause_description": "Labeling Change Control",
      "action": "On March 4, 2026, firm began notifying customers via first-class mail. Customers were informed they may still use the BiDop 3 device for vascular applications, but that the device is not cleared for fetal usage. \n\nKoven Technology, Inc. will provide a replacement operation manual for devices that are being amended to remove fetal use indications.",
      "product_quantity": "34",
      "distribution_pattern": "US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.",
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        "registration_number": [
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        "device_name": "Flowmeter, Blood, Cardiovascular",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2100",
        "device_class": "2"
      }
    }
  ]
}