{
  "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": "2026-08-13",
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      "event_date_initiated": "2024-10-03",
      "event_date_posted": "2024-11-05",
      "recall_status": "Open, Classified",
      "res_event_number": "95509",
      "product_code": "FDE",
      "product_description": "DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06",
      "code_info": "UDI/ DI 00749756913393 (each), 50749756913398 (case):  Lot Numbers:  lot 59244907 exp 10/1/2025",
      "firm_fei_number": "1043214",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "city": "Powell",
      "state": "TN",
      "postal_code": "37849-4703",
      "additional_info_contact": "Theresa Marsee\n865-362-6465",
      "reason_for_recall": "DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.",
      "root_cause_description": "Under Investigation by firm",
      "action": "DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email.  The notice explained the issue, potential risk, and requested the return of the affected packs.  If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.",
      "product_quantity": "95 units",
      "distribution_pattern": "US Nationwide distribution in the state of OH.",
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