{
  "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": "Powell",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92445",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "address_2": "N/A",
      "postal_code": "37849-4703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2088-2023",
      "product_description": "Custom medical procedure packs labeled as:    a)\tSTANDARD OB PACK ASCENSION WI, REF 89-10640  b)\tANGIO PACK, REF 89-10901  c)\tBASIN, REF 89-1924  d)\tCYSTO PACK, REF 89-7133  e)\tTOTAL HIP PACK, REF 89-9134  f)\tEMERGENCY C-SECTION PACK, REF 89-9478",
      "product_quantity": "328 packs",
      "reason_for_recall": "The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.",
      "recall_initiation_date": "20230530",
      "center_classification_date": "20230703",
      "report_date": "20230712",
      "code_info": "a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers:  58737945;   b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers:  58820749;   c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers:  58746227;   d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers:  58789323;   e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers:  58701336;   f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers:  58738454"
    }
  ]
}