{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
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  "results": [
    {
      "cfres_id": "197605",
      "product_res_number": "Z-1029-2023",
      "event_date_initiated": "2022-11-17",
      "event_date_posted": "2023-01-27",
      "recall_status": "Open, Classified",
      "res_event_number": "91387",
      "product_code": "OJH",
      "product_description": "Non-sterile procedural trays labeled as CRANI, 2 per case",
      "code_info": "Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Karin Johnson\n886-359-1704",
      "reason_for_recall": "Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.",
      "root_cause_description": "Device Design",
      "action": "Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022.  Consignees were instructed to over-label the sterile kits with a warning label indicating  Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned.  Customers were also instructed to complete and return the response form.",
      "product_quantity": "12 cases (24 units)",
      "distribution_pattern": "US Nationwide distribution in the states of AR, MD, WA, WI.",
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        "device_name": "Orthopedic Tray",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      }
    }
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}