{
  "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": "2026-04-15",
    "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": "78843",
      "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": "Distributed to states of: CA and MO.",
      "recall_number": "Z-0334-2018",
      "product_description": "DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows:  (a) Shoulder Arthroscopy Pack 89-8686.01  (b) Shoulder Arthroscopy Pack 89-8686.02  (c) Knee Arthro Pack 89-8687.01  (d) Knee Arthro Pack 89-8687.02    Product Usage: general surgical",
      "product_quantity": "226 kits",
      "reason_for_recall": "DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.",
      "recall_initiation_date": "20171219",
      "center_classification_date": "20180112",
      "termination_date": "20180621",
      "report_date": "20180124",
      "code_info": "(a) Lot number: 38527131  (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133,  (c) Lot numbers: 38497294, 38564514, 40146320, 40990651  (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122"
    }
  ]
}