{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Temple Terrace",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93086",
      "recalling_firm": "American Contract Systems, Inc.",
      "address_1": "7802 E Telecom Pkwy",
      "address_2": "N/A",
      "postal_code": "33637-0928",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IA.",
      "recall_number": "Z-0176-2024",
      "product_description": "Pediatric Heart SJH, REF SJPH34K",
      "product_quantity": "72 cases",
      "reason_for_recall": "During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and   Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.",
      "recall_initiation_date": "20230901",
      "center_classification_date": "20231026",
      "report_date": "20231101",
      "code_info": "UDI/DI 00191072167064, Lot Numbers:  975231"
    }
  ]
}