{
  "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": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97388",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution to FL and IL. No OUS distribution reported.",
      "recall_number": "Z-2479-2025",
      "product_description": "Medline Kits containing BD SureStep Foley Tray Systems:    SKU/Description:    CDS984076J\tGYN ROBOTIC  DYNJG001004A\tLAVH MINOR  DYNJG901001B\tCRANIOTOMY  DYNJ908819B\tKIT CRANIOTOMY    (only units from SKU DYNJG001004A\tLAVH MINOR were distributed)",
      "product_quantity": "4 ea",
      "reason_for_recall": "Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).",
      "recall_initiation_date": "20250723",
      "center_classification_date": "20250828",
      "report_date": "20250903",
      "code_info": "Medline Kit SKU Description UDI (EA) UDI (Case) Kit Lot Number CDS984076J GYN ROBOTIC 10198459283147 40198459283148 25DBH902 DYNJG001004A LAVH MINOR 10195327677329 40195327677320 25ELA892 DYNJG901001B CRANIOTOMY 10198459164316 40198459164317 25DLB031 DYNJ908819B KIT CRANIOTOMY 10198459102677 40198459102678 25DDA909",
      "more_code_info": ""
    }
  ]
}