{
  "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": "196121",
      "product_res_number": "Z-0169-2023",
      "event_date_initiated": "2022-09-07",
      "event_date_posted": "2022-11-02",
      "recall_status": "Open, Classified",
      "res_event_number": "90887",
      "product_code": "OAD",
      "pma_numbers": [
        "P030031"
      ],
      "product_description": "THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S.  Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.",
      "code_info": "UDI-DI/Lots: 10846835010183/30779056L, 30808001L, 30814782L, 30814783L, 30779172L",
      "firm_fei_number": "3012236936",
      "recalling_firm": "Johnson & Johnson Surgical Vision, Inc.",
      "address_1": "31 Technology Dr Ste 200 31 Technology Dr",
      "address_2": "Ste 200",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-2302",
      "reason_for_recall": "Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.",
      "root_cause_description": "Process control",
      "action": "On 09/07/2022, recall notices were mailed and emailed to customers requesting the following:\n\n1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully.\n2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel.\n3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used.\n4) Complete and return the business response form.\nQuestions can be directed to the recalling firm representative. The following email address was provided: OneMD-Field-Actions@its.jnj.com",
      "product_quantity": "91",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.",
      "openfda": {
        "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P010068",
          "P020025",
          "P950005",
          "P030031",
          "P150005",
          "P060019",
          "P110016",
          "P040042",
          "P050024"
        ],
        "registration_number": [
          "3010291427",
          "2030404",
          "2184149",
          "9680001",
          "3016245399",
          "3017060084",
          "2032098",
          "3002807314",
          "3012179728",
          "3005334138",
          "1650907",
          "9673241",
          "1000121056",
          "3004016520",
          "3010273872",
          "2124215",
          "3004859241",
          "3012260771",
          "1721983",
          "3006634485",
          "1643817",
          "3009243923",
          "3001592626",
          "2032112",
          "3013403214",
          "1721686",
          "9681260",
          "3004105270",
          "3010653929",
          "3013581838",
          "3013300026",
          "3008452825",
          "3010280625",
          "2182269",
          "1319639",
          "3007695959",
          "3007029079",
          "1721504",
          "3001763079",
          "3000279201",
          "2182208",
          "3010705768",
          "3019807891",
          "2028523",
          "3012520654",
          "3008093809",
          "1928237",
          "3011120183",
          "9612164",
          "3012552532",
          "3008328679",
          "3015537323"
        ],
        "fei_number": [
          "3010291427",
          "1000519796",
          "3016245399",
          "3017060084",
          "3002807314",
          "3012179728",
          "1000138054",
          "3003076831",
          "3005334138",
          "3003058448",
          "1000125147",
          "3002806434",
          "1000121056",
          "3004016520",
          "3010273872",
          "2124215",
          "3002681132",
          "3003248396",
          "3004859241",
          "3012260771",
          "3006634485",
          "1000139754",
          "1643817",
          "3009243923",
          "3001592626",
          "3002808445",
          "1000064530",
          "3013403214",
          "1721686",
          "3004105270",
          "3010653929",
          "3013581838",
          "3013300026",
          "3008452825",
          "3010280625",
          "2182269",
          "3007695959",
          "3002806565",
          "1721504",
          "3001763079",
          "3000279201",
          "2182208",
          "3007029079",
          "3010705768",
          "3019807891",
          "3012520654",
          "3008093809",
          "1928237",
          "3011120183",
          "3012552532",
          "3008328679",
          "3015537323"
        ]
      }
    }
  ]
}