{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88141",
      "recalling_firm": "Axonics Modulation Technologies, Inc.",
      "address_1": "26 Technology Dr",
      "address_2": "",
      "postal_code": "92618-2380",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US nationwide distribution.",
      "recall_number": "Z-2077-2021",
      "product_description": "BULKAMID, URETHRAL BULKING SYSTEM model # 50050  containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476",
      "product_quantity": "2,702 units",
      "reason_for_recall": "Lack of Sterility Assurance; needle in procedure pack labeled  as sterile may not have been adequately sterilized",
      "recall_initiation_date": "20210603",
      "center_classification_date": "20210715",
      "termination_date": "20220420",
      "report_date": "20210721",
      "code_info": "Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA",
      "more_code_info": ""
    }
  ]
}