{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216662",
      "product_res_number": "Z-0473-2026",
      "event_date_initiated": "2025-10-01",
      "event_date_posted": "2025-11-07",
      "recall_status": "Open, Classified",
      "res_event_number": "97822",
      "product_code": "NUJ",
      "k_numbers": [
        "K160333"
      ],
      "product_description": "Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed",
      "code_info": "UDI/DI 10888277680395 (each), 20888277680392 (case), All Lots",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail.  The notice explained the issue, potential risk to health, and requested the following:  \n\"REQUIRED ACTION:\n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.\n2. 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.\nWebsite link: https://recalls.medline.com\nRecall Reference #: R-25-206\nRecall Code: \n3. Your account will receive credit once the response form is submitted.\n4. 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. Please request that customers destroy any affected product. You should include your customers  quantities on your response form.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.\"",
      "product_quantity": "60,917 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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          "K090661",
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        "registration_number": [
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        ],
        "device_name": "Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}