{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 7
    }
  },
  "results": [
    {
      "cfres_id": "218101",
      "product_res_number": "Z-1319-2026",
      "event_date_initiated": "2025-12-22",
      "event_date_posted": "2026-02-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98277",
      "product_code": "NLH",
      "k_numbers": [
        "K241224"
      ],
      "product_description": "Medline ReNewal Reprocessed Webster CS Catheters:\n\nWebster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer\nBD710DF282CRH;\nWebster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer\nBD710DF282RRH\nBD710FJ282RRH;\nWebster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer\nBD710FJ282CRH;",
      "code_info": "BD710DF282CRH\nUDI-DI 10197344044023\nLots\nEP250429\nEP250808;\n\nBD710DF282RRH\nUDI-DI 10197344044030\nLots \nEP250429\nEP250808;\n\nBD710FJ282RRH\nUDI-DI 10197344044054\nLots\nEP250429\nEP250808;\n\nBD710FJ282CRH\nUDI-DI (case) 40197344044048\n(ea) 10197344044047\nLots \nEP250429\nEP250808",
      "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": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025",
      "root_cause_description": "Under Investigation by firm",
      "action": "On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer.\n\n***Updated 5/18/26***\n\nThe firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.",
      "product_quantity": "228",
      "distribution_pattern": "Distribution US nationwide.",
      "openfda": {
        "k_number": [
          "K052414",
          "K150357",
          "K030109",
          "K012687",
          "K153153",
          "K250772",
          "K211276",
          "K121158",
          "K181897",
          "K022316",
          "K112232",
          "K160496",
          "K051043",
          "K161393",
          "K221854",
          "K200205",
          "K170922",
          "K100254",
          "K190127",
          "K240826",
          "K241224",
          "K030187",
          "K040751",
          "K161464",
          "K023180",
          "K153006",
          "K180710",
          "K043392",
          "K161272",
          "K182488",
          "K081329",
          "K082023",
          "K012678",
          "K241156",
          "K252405",
          "K112292",
          "K242225",
          "K052603",
          "K050763",
          "K090323",
          "K030114",
          "K171503",
          "K203655",
          "K160242",
          "K181618",
          "K191170",
          "K240972",
          "K030026",
          "K012523",
          "K233825",
          "K042074",
          "K151617",
          "K051220",
          "K181458",
          "K161827",
          "K162251",
          "K171788",
          "K193263",
          "K101789",
          "K030279",
          "K012708",
          "K181056",
          "K043393",
          "K221067",
          "K160421",
          "K061045",
          "K160303",
          "K092158",
          "K012688",
          "K043513"
        ],
        "registration_number": [
          "3011610434",
          "3011024991",
          "1319639",
          "3009888344",
          "2183744",
          "3011276773",
          "3032391",
          "3009350690",
          "2011171",
          "2032112",
          "2090040"
        ],
        "fei_number": [
          "3002299608",
          "3003076831",
          "3011610434",
          "1000138054",
          "3011024991",
          "3009888344",
          "3002615969",
          "2183744",
          "3011276773",
          "3009350690",
          "2011171"
        ],
        "device_name": "Catheter, Recording, Electrode, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}