{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220873",
      "product_res_number": "Z-2615-2026",
      "event_date_initiated": "2026-05-15",
      "event_date_posted": "2026-07-02",
      "recall_status": "Open, Classified",
      "res_event_number": "99122",
      "product_code": "NLH",
      "k_numbers": [
        "K241156"
      ],
      "product_description": "Reprocessed Electrophysiology Catheters and Ultrasound Catheters\n\nItem no. 401206RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;\n\nItem no. 401305RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.",
      "code_info": "Lot EP250203\n\nItem no. 401206RH - UDI-DI\t10197344043767;\nItem no. 401305RH - UDI-DI 10197344043637.",
      "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\n800-633-5463",
      "reason_for_recall": "Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.",
      "root_cause_description": "Under Investigation by firm",
      "action": "This is an expansion of recall RES 98277. On May 15, 2026, firm notified affected consignee via letter titled \"URGENT MEDICAL DEVICE RECALL\". All affected product has expired.\n\nThe consignee was instructed to quarantine all affected product and destroy it.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the state of TX.",
      "openfda": {
        "k_number": [
          "K043393",
          "K161272",
          "K181458",
          "K030109",
          "K162251",
          "K170922",
          "K181897",
          "K211276",
          "K182488",
          "K181618",
          "K052603",
          "K150357",
          "K160242",
          "K181056",
          "K160496",
          "K022316",
          "K050763",
          "K112292",
          "K160303",
          "K221854",
          "K061045",
          "K051043",
          "K092158",
          "K082023",
          "K171788",
          "K190127",
          "K153153",
          "K052414",
          "K180710",
          "K012523",
          "K252405",
          "K030114",
          "K051220",
          "K233825",
          "K012678",
          "K250772",
          "K090323",
          "K023180",
          "K203655",
          "K241156",
          "K240972",
          "K100254",
          "K241224",
          "K240826",
          "K101789",
          "K171503",
          "K012687",
          "K161464",
          "K042074",
          "K153006",
          "K030026",
          "K221067",
          "K151617",
          "K160421",
          "K030187",
          "K043513",
          "K193263",
          "K200205",
          "K030279",
          "K112232",
          "K040751",
          "K081329",
          "K121158",
          "K242225",
          "K012688",
          "K161393",
          "K012708",
          "K043392",
          "K191170",
          "K161827"
        ],
        "registration_number": [
          "3032391",
          "3011024991",
          "3009350690",
          "3011276773",
          "3009888344",
          "1319639",
          "3011610434",
          "2011171",
          "2032112",
          "2090040",
          "2183744"
        ],
        "fei_number": [
          "3009350690",
          "3011276773",
          "3003076831",
          "1000138054",
          "3002299608",
          "3011024991",
          "3011610434",
          "2011171",
          "3002615969",
          "3009888344",
          "2183744"
        ],
        "device_name": "Catheter, Recording, Electrode, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}