{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "210607",
      "product_res_number": "Z-0349-2025",
      "event_date_initiated": "2024-10-04",
      "event_date_posted": "2024-11-08",
      "recall_status": "Open, Classified",
      "res_event_number": "95563",
      "product_code": "OJH",
      "product_description": "CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A",
      "code_info": "UDI-DI:10889942848447;\nLot Number: 24EBP466",
      "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": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "An URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer.\n\nREQUIRED ACTION:\n1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.The login for completing the response form is:Website link: https://recalls.medline.comRecall Reference #: R-24-207-FGX1Recall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "36 units",
      "distribution_pattern": "US Nationwide distribution in the state of TN.",
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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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}