{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95605",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "6000 Nathan Ln N",
      "address_2": "",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-0528-2025",
      "product_description": "smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x  70cm, REF 14-504-68 and REF 14-504-68JP",
      "product_quantity": "10,223 units",
      "reason_for_recall": "Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube.  This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.",
      "recall_initiation_date": "20241028",
      "center_classification_date": "20241125",
      "report_date": "20241204",
      "code_info": "REF 14-504-68, UDI/DI 35021239002586, Lot Numbers:  0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643;  REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers:  0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643",
      "more_code_info": ""
    }
  ]
}