{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Fajardo",
      "state": "PR",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71721",
      "recalling_firm": "Customed, Inc",
      "address_1": "Calle Igualdad Final #7",
      "address_2": "N/A",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Only in Puerto Rico.",
      "recall_number": "Z-2684-2015",
      "product_description": "SURG GOWN POLYREINF LGE CUSTOM 28/CS      Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  .",
      "product_quantity": "10805",
      "reason_for_recall": "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.",
      "recall_initiation_date": "20150710",
      "center_classification_date": "20150903",
      "termination_date": "20170412",
      "report_date": "20150909",
      "code_info": "Code:900522  Lots:  141116021 exp. 11/30/15  141116021 exp. 11/30/15  150117022 exp. 3/31/16  150117022 exp. 3/31/16  150317997 exp. 3/31/16  150418241 exp. 4/30/16  150418241 exp. 4/30/16  150518822 exp. 5/31/16  150518822 exp. 5/31/16"
    }
  ]
}