{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214767",
      "product_res_number": "Z-2287-2025",
      "event_date_initiated": "2025-07-02",
      "event_date_posted": "2025-08-11",
      "recall_status": "Open, Classified",
      "res_event_number": "97185",
      "product_code": "PZR",
      "k_numbers": [
        "K230796"
      ],
      "product_description": "Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28",
      "code_info": "Lot numbers: V2408xxxx and runs through V2519xxxx\nUDI: 11-110/00850052017033;\n11-310-K/00860005396948;\n11-320-K/00860005396986;\n11-321-K/00850052017163;\n11-310-K-28/00850052017088;\n11-320-K-28/00850052017071;\n11-321-K-28/00850052017170",
      "firm_fei_number": "3017987352",
      "recalling_firm": "Spark Biomedical Inc",
      "address_1": "19830 Fm 1093 Rd Ste 401 19830 Fm 1093 Rd",
      "address_2": "Ste 401",
      "city": "Richmond",
      "state": "TX",
      "postal_code": "77407-8621",
      "reason_for_recall": "Due to manufacturing issue, neurostimulator device may experience  \"cable disconnect\" error message and interruption to stimulation output.",
      "root_cause_description": "Process control",
      "action": "On  July 2, 2025, Spark Biomedical initiated a Urgent Medical Device Recall via phone. During the phone conversation, Spark Biomedical will ask consignees to take the following actions:\n\n1. Spark Biomedical will replace all affected00 units at no cost. Even if the units appear to be working.\n\n2. Current devices may continue to be used until they are replaced.\n\n3. Please perform a check of the cable to patient controller connection before use.  If this connection is loose or moves, please discontinue use of that patient controller device and quarantine that device until the replacement arrives.\n\n4. Please notify all appropriate personnel at your facility that need to know about this recall.",
      "product_quantity": "78 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K230796",
          "K201873",
          "K173861",
          "K211971",
          "K251246",
          "K233166",
          "K221231",
          "DEN170018"
        ],
        "registration_number": [
          "3011743372",
          "3008255748",
          "3039168176",
          "3010350335",
          "3014122529",
          "3017987352"
        ],
        "fei_number": [
          "3011743372",
          "3008255748",
          "3039168176",
          "3010350335",
          "3014122529",
          "3017987352"
        ],
        "device_name": "Percutaneous Nerve Stimulator For Opioid Withdrawal",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5896",
        "device_class": "2"
      }
    }
  ]
}