{
  "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,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "218983",
      "product_res_number": "Z-1690-2026",
      "event_date_initiated": "2026-02-13",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98524",
      "product_code": "PIO",
      "k_numbers": [
        "K151628"
      ],
      "product_description": "ENFIT G-TUBE CONNECTOR, MEDLINE\nItem No. ENFIT1010GC",
      "code_info": "UDI-DI\n10888277314719 (ea)\t40888277314710(case)\n\n\nAll Lots",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n800-633-5463",
      "reason_for_recall": "Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.",
      "root_cause_description": "Process change control",
      "action": "On February 13, 2026, the firm notified affected consignees via Urgent Medical Device Recall letters delivered through First Class mail and email. Customers were instructed to destroy all affected ENFit G-Tube connectors and kits that contain the G-Tube connectors.",
      "product_quantity": "651,789",
      "distribution_pattern": "Worldwide - US Nationwide and the countries of Canada.",
      "openfda": {
        "k_number": [
          "K233190",
          "K231299",
          "K150010",
          "K150034",
          "K151628",
          "K140581",
          "K151237",
          "K162254",
          "K220165"
        ],
        "device_name": "Enteral Specific Transition Connectors",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2",
        "registration_number": [
          "3031915926",
          "8020785",
          "3013788631",
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}