{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lower Hutt",
      "state": "",
      "country": "New Zealand",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81166",
      "recalling_firm": "AROA Biosurgery, LTD.",
      "address_1": "69 Gracefield Road",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Visit",
      "distribution_pattern": "The products were distributed to the following US states:  AL, CA, FL, IN, MA, MI, NH, and NY.",
      "recall_number": "Z-0415-2019",
      "product_description": "OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G",
      "product_quantity": "881 total",
      "reason_for_recall": "Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.",
      "recall_initiation_date": "20180406",
      "center_classification_date": "20181109",
      "termination_date": "20190415",
      "report_date": "20181121",
      "code_info": "ERT-6E12  ERT-7F02",
      "more_code_info": ""
    }
  ]
}