{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "202915",
      "product_res_number": "Z-0120-2024",
      "event_date_initiated": "2023-08-03",
      "event_date_posted": "2023-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "92920",
      "product_code": "NLQ",
      "k_numbers": [
        "K193563"
      ],
      "product_description": "MEDLINE  ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.",
      "code_info": "UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers:  498739, 498740, 499057, 499143, 499227",
      "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": "Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.",
      "root_cause_description": "Packaging",
      "action": "Medline issued a recall notice to its consignees by email on 08/03/2023.  The notice explained the problem and the potential risk.  Those consignees who have transferred possession of the affected product were directed to notify their customers.  The firm is seeking the return of the affected product.  \n\nAn error in the model number was noted (missing an \"R\" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.",
      "product_quantity": "18 units",
      "distribution_pattern": "US",
      "openfda": {
        "k_number": [
          "K083060",
          "K182272",
          "K250898",
          "K143562",
          "K043358",
          "K030598",
          "K202554",
          "K170955",
          "K241606",
          "K100537",
          "K161693",
          "K111794",
          "K132566",
          "K012571",
          "K150524",
          "K133672",
          "K050343",
          "K233471",
          "K193563",
          "K043225",
          "K151405",
          "K093702",
          "K190610",
          "K170456",
          "K124033",
          "K173627",
          "K043315"
        ],
        "registration_number": [
          "3030153385",
          "1061124",
          "3011024991",
          "1417592",
          "3009350690",
          "1018470",
          "3024021261",
          "3032391",
          "1650907",
          "1056128",
          "2183744",
          "2011171"
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          "1417592",
          "3002681132",
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          "1018470",
          "1000512168",
          "3024021261",
          "3002299608",
          "2183744",
          "2011171",
          "1000132435"
        ],
        "device_name": "Single-Use Reprocessed Ultrasonic Surgical Instruments",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}