{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99122",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of TX.",
      "recall_number": "Z-2615-2026",
      "product_description": "Reprocessed Electrophysiology Catheters and Ultrasound Catheters    Item no. 401206RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 4 Elec. 10mm;    Item no. 401305RH,\tSt. Jude Medical Response\" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.",
      "product_quantity": "3",
      "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.",
      "recall_initiation_date": "20260515",
      "center_classification_date": "20260702",
      "report_date": "20260708",
      "code_info": "Lot EP250203  Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637."
    }
  ]
}