{
  "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-2644-2015",
      "product_description": "GOWN COOL IMPEV. XLGE BREATHABLE  24/CS CUSTOMED   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  .",
      "product_quantity": "216",
      "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:9002592  Lots:  140915320 exp. 9/30/19  150116795 exp. 3/31/16  150217395 exp. 3/31/16  150317646 exp. 3/31/16  150317849 exp. 5/31/16  150317850 exp. 5/31/16  150317848 exp. 5/31/16  150418378 exp. 6/30/16"
    }
  ]
}