{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99403",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Panama.",
      "recall_number": "Z-2992-2026",
      "product_description": "Medline breathing circuits labeled as:    1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07);   2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09);   3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13);   4)  HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14);  5)  HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15);   6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).",
      "product_quantity": "145525 units",
      "reason_for_recall": "Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.",
      "recall_initiation_date": "20260713",
      "center_classification_date": "20260821",
      "report_date": "20260902",
      "code_info": "1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers;  2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers;  3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers;  4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers;  5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers;  6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers."
    }
  ]
}