{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "222115",
      "product_res_number": "Z-3221-2026",
      "event_date_initiated": "2026-07-28",
      "event_date_posted": "2026-09-18",
      "recall_status": "Open, Classified",
      "res_event_number": "99660",
      "product_code": "ECX",
      "product_description": "HF2P0ST9\nHomeFill Oxygen System\nHomeFill Cylinder M9 with CGA870 Compatible Post Valve",
      "code_info": "UDI:00850018761369/Serial #s: 24IKMA00532\t24IKMA0053M\t24IKMA0054N\t24IKMA005G8\t24IKMA005AP\t24IKMA005QB\t24IKMA005Q4\t24IKMA005PM\t24IKMA005QJ\t24IKMA005QX\t24IKMA005PJ\t24IKMA005SW\t24IKMA005RB\t24IKMA00612\t24IKMA0067E\t24IKMA0066L\t24IKMA0068U\t24IKMA00685\t24IKMA006AQ\t24IKMA006B7\t24IKMA006BG",
      "firm_fei_number": "3013095415",
      "recalling_firm": "Ventec Life Systems, Inc.",
      "address_1": "22002 26th Ave Se",
      "city": "Bothell",
      "state": "WA",
      "postal_code": "98021-4903",
      "additional_info_contact": "George Koos\n1-863-2266285",
      "reason_for_recall": "Labeling; Oxygen Cylinders do not contain required medical gas labeling",
      "root_cause_description": "Process control",
      "action": "On July 28, 2026, Ventec Life Systems Inc. issued a Urgent: Medical Device Recall notification to affected consignees via: certified mail. Ventec ask consignees to take the following actions: \n\n1. Immediately discontinue use of affected HomeFill Oxygen Cylinders.\n2. Inspect current stock, quarantine/segregate any unused affected products, remove affected product from clinical service and segregate to prevent further use until the enclosed label correction has been completed.\n3. Use an unaffected oxygen cylinder for patient support.\n4. If you have distributed or transferred affected product to other facilities, caregivers, or end users, you must promptly notify them of this recall and provide a copy of this notification.\n\n5.. Confirm receipt of this notification letter by returning the enclosed Customer Response Form to React Health WITHIN 7 DAYS OF RECEIPT.\n6. Upon receipt of the Customer Response Form, React Health will arrange for shipment of the label and instructions to apply the label to affected cylinders along with an update confirmation letter.\n7. Update the affected product and return the completed confirmation letter to React Health. Contact Customer Support at 863-226 -6285 to discuss completing the form, if necessary.",
      "product_quantity": "21 units",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IA, OH, NE, TN.",
      "openfda": {
        "k_number": [
          "K063354",
          "K053117",
          "K161472",
          "K033897",
          "K132778",
          "K142149",
          "K101792",
          "K161179",
          "K153518",
          "K143060",
          "K062300",
          "K771246",
          "K131386"
        ],
        "device_name": "Cylinder, Compressed Gas, And Valve",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.2700",
        "device_class": "1",
        "registration_number": [
          "3012002722",
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}