{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "cfres_id": "215765",
      "product_res_number": "Z-2610-2025",
      "event_date_initiated": "2025-07-31",
      "event_date_posted": "2025-09-26",
      "recall_status": "Open, Classified",
      "res_event_number": "97496",
      "product_code": "NLH",
      "k_numbers": [
        "K221067"
      ],
      "product_description": "Reprocessed Livewire Steerable Electrophysiology Catheter\n\nItem Numbers 401575RH\n401582RH\n401600RH\n401603RH\n401606RH\n401652RH\n401653RH\n401654RH\n401904RH\n401905RH\n401908RH\n401914RH\n401915RH\n401918RH\n401932RH\n401933RH\n401934RH\n401938RH\n401939RH\n401940RH\n401941RH\n401991RH",
      "code_info": "Item Number/UDI (ea)/UDI(case):\n\n401575RH\n10888277407497\n20888277407494;\n401582RH\n10888277407510\n20888277407517;\n401600RH\n10888277407541\n20888277407548;\n401603RH\n10888277407558\n20888277407555;\n401606RH\n10888277407565\n20888277407562;\n401652RH\n10888277407572\n20888277407579;\n401653RH\n10888277407589\n20888277407586;\n401654RH\n10888277407596\n20888277407593;\n401904RH\n10888277407602\n20888277407609;\n401905RH\n10888277407619\n20888277407616;\n401908RH\n10197344020966\n20197344020963;\n401914RH\n10888277407527\n20888177407524;\n401915RH\n10888277407626\n20888277407623;\n401918RH\n10888277407640\n20888277407647;\n401932RH\n10888277407671\n20888277407678;\n401933RH\n10888277407688\n20888277407685;\n401934RH\n10888277407695\n20888277407692;\n401938RH\n10888277407701\n20888277407708;\n401939RH\n10888277407718\n20888277407715;\n401940RH\n10888277407480\n20888277407487;\n401941RH\n10888277407725\n20888277407722;\n401991RH\n10888277407756\n2088277407753;\n\nLOTS\n\nEP230724\nEP230731\nEP230803\nEP230816\nEP230914\nEP231017\nEP231116\nEP240108\nEP240122\nEP240212\nEP240227\nEP240311\nEP240322\nEP240411\nEP240415\nEP240422\nEP240429\nEP240507\nEP240514\nEP240520\nEP240528\nEP240607\nEP240611\nEP240710\nEP240715\nEP240723\nEP240805\nEP240812\nEP240820\nEP240829\nEP240911\nEP240923\nEP240930\nEP241008\nEP241030\nEP241125\nEP250108",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "reason_for_recall": "Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/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": "On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit.\n\nCustomers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.",
      "product_quantity": "7913 eaches",
      "distribution_pattern": "Domestic US distribution nationwide. International distribution pending. No international distribution.",
      "openfda": {
        "k_number": [
          "K162251",
          "K160421",
          "K181618",
          "K160496",
          "K160303",
          "K012523",
          "K211276",
          "K081329",
          "K092158",
          "K161464",
          "K153153",
          "K161827",
          "K051220",
          "K171788",
          "K250772",
          "K221854",
          "K012688",
          "K242225",
          "K040751",
          "K200205",
          "K043513",
          "K203655",
          "K252405",
          "K030114",
          "K012678",
          "K161393",
          "K030279",
          "K170922",
          "K030026",
          "K100254",
          "K182488",
          "K101789",
          "K082023",
          "K171503",
          "K193263",
          "K221067",
          "K042074",
          "K181458",
          "K030109",
          "K121158",
          "K161272",
          "K150357",
          "K160242",
          "K061045",
          "K050763",
          "K181897",
          "K233825",
          "K090323",
          "K180710",
          "K240972",
          "K241156",
          "K012708",
          "K023180",
          "K052603",
          "K241224",
          "K043393",
          "K030187",
          "K240826",
          "K022316",
          "K112292",
          "K190127",
          "K181056",
          "K153006",
          "K151617",
          "K051043",
          "K112232",
          "K191170",
          "K052414",
          "K043392",
          "K012687"
        ],
        "registration_number": [
          "3009888344",
          "2032112",
          "1319639",
          "3011610434",
          "3011276773",
          "3009350690",
          "2011171",
          "2090040",
          "3011024991",
          "2183744",
          "3032391"
        ],
        "fei_number": [
          "3002615969",
          "3009888344",
          "1000138054",
          "3011610434",
          "3011276773",
          "3002299608",
          "3009350690",
          "2011171",
          "2183744",
          "3011024991",
          "3003076831"
        ],
        "device_name": "Catheter, Recording, Electrode, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      }
    }
  ]
}