{
  "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": "219053",
      "product_res_number": "Z-2133-2026",
      "event_date_initiated": "2026-02-01",
      "event_date_posted": "2026-05-08",
      "recall_status": "Open, Classified",
      "res_event_number": "98548",
      "product_code": "LWQ",
      "pma_numbers": [
        "P000037"
      ],
      "product_description": "On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33",
      "code_info": "UDI-DI: 00851788001303.\nSerial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411.\nExpiration: 2031Dec17",
      "firm_fei_number": "3001584317",
      "recalling_firm": "On-X Life Technologies, Inc.",
      "address_1": "1300 E Anderson Ln Ste B 1300 E Anderson Ln",
      "address_2": "Ste B",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78752-1739",
      "additional_info_contact": "512-339-8000",
      "reason_for_recall": "Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 2/1/2026, the firm contacted their customer to quarantine affected devices.",
      "product_quantity": "10",
      "distribution_pattern": "International distribution to the country of South Korea.",
      "openfda": {
        "pma_number": [
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          "P870038",
          "P040021",
          "P100029",
          "P830039",
          "P970002",
          "P850006",
          "P780008",
          "P790018",
          "P000037",
          "P990046",
          "P810002"
        ],
        "device_name": "Heart-Valve, Mechanical",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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