{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Powell",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78517",
      "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": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of GA, IN, FL, and PA",
      "recall_number": "Z-0199-2018",
      "product_description": "DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads:  a) Incision and Drainage Tray, REF 47-763.04  b) Incision and Drainage Tray, REF 47-763.06  c) Incision and Drainage Tray, REF 47-763.07  d) Cricothyreotomy Ambulance Kit, REF 89-6752.01  e) Incision and Drainage Tray, REF 89-6818.02  f) Plastic Pack, REF 89-7212.04  g) Plastic Pack, REF 89-7212.05    Product Usage:  Custom surgical and procedural kits",
      "product_quantity": "5946 units",
      "reason_for_recall": "Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.",
      "recall_initiation_date": "20171016",
      "center_classification_date": "20171206",
      "termination_date": "20200821",
      "report_date": "20171213",
      "code_info": "a) REF 47-763.04, Lot Numbers:42728139, 42812373  b) REF 47-763.06, Lot Numbers:43638080, 44508341  c) REF 47-763.07, Lot Number:44877040  d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919  e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458  f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543  g) REF 89-7212.05, Lot Number:45456132",
      "more_code_info": ""
    }
  ]
}