{
  "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-2086-2023",
      "product_description": "Custom medical procedure packs labeled as:       a)\tOPEN HEART TRACECART, REF '53-1941;   b)\tCARDIAC CATH PACK, REF '89-10045;   c)\tSHOULDER PACK, REF '89-10115;   d)\tMINOR ORTHO PACK, REF '89-10213;   e)\tTOTAL KNEE PACK PGYBK, REF '89-10505;   f)\tANTERIOR HIP PACK PGYBK, REF '89-10563;   g)\tORTHO X-RAY PACK, REF '89-1495;   h)\tGU PACK, REF '89-4479;   i)\tBREAST PACK, REF '89-5424;   j)\tSHOULDER ARTHROSCOPY PK, REF '89-6606;   k)\tGYN PACK, REF '89-7369;   l)\tENT PACK, REF '89-7378;   m)\tTOTAL HIP PACK PGYBK, REF '89-7540;    n)\tEPIDURAL TRAY/CUSTOM, REF '89-8061;   o)\tBREAST BIOPSY TRAY, REF '89-8187;   p)\tBEACH CHAIR PACK, REF '89-8439;   q)\tTOTAL KNEE PACK PGYBK, REF '89-8445;   r)\tCYSTO PACK, REF '89-8482;   s)\tSINGLE BASIN PLUS, REF '89-9131;   t)\tTOTAL HIP PACK, REF '89-9287;   u)\tARTHROSCOPY PACK, REF '89-9626;   v)\tSHOULDER PACK, REF '89-9632  CYSTO PACK, REF '89-10049  BEACH CHAIR SHOULDER PACK, REF  '89-10721  EXTREMITY PACK, REF  '89-10959  HYSTEROSCOPY PACK, REF '89-10960  VERITHENA VENOUS ABLATION PACK, REF '89-10977  CYSTO BASIN SET, REF  '89-2577  OPEN HEART PACK, REF  '89-8572  BACK PACK, REF '89-9292",
      "product_quantity": "4225 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 '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers:  59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383;   b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers:  58714313;   c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128  (unit), Lot Numbers:  58746278;   d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers:  58745371;   e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers:  58774885, 58774885;   f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers:  58800174;   g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers:  58762104;   h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers:  58810330;   i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit), , Lot Numbers:  58698974;   j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit), , Lot Numbers:  58698907;   k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit), , Lot Numbers:  58777761;   l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit), , Lot Numbers:  58811834;   m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers:  58737081;   n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers:  58698042;   o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers:  58736862;   p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers:  58823595;   q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit), , Lot Numbers:  58697963;   r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers:  58789411;   s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit), , Lot Numbers:  58808416;   t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit), , Lot Numbers 58789260;    u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit), , Lot Numbers:  58738315  v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit), , Lot Numbers:  58701598"
    }
  ]
}