{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "218964",
      "product_res_number": "Z-1688-2026",
      "event_date_initiated": "2026-02-23",
      "event_date_posted": "2026-03-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98514",
      "product_code": "FSY",
      "k_numbers": [
        "K120392"
      ],
      "product_description": "Stryker CHROMOPHARE Softlit Ring Surgical Light System\nREF: CH00000001",
      "code_info": "UDI: 07613327296167; All Lots",
      "firm_fei_number": "3002975342",
      "recalling_firm": "Stryker Communications",
      "address_1": "571 Silveron Blvd",
      "city": "Flower Mound",
      "state": "TX",
      "postal_code": "75028",
      "additional_info_contact": "Stryker Customer Care\n1800-624-4422 Ext. 1",
      "reason_for_recall": "Surgical light  assembly may not adequate support the weight of the ceiling cover.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On February 23, 2026 Stryker issued \"Urgent: Medical Device Recall\" via E-Mail to affected consignees. Stryker ask consignees to take the following actions: \n\n1. Inform individuals within your organization who need to be aware of this action.\n\n2.Check your internal inventory to locate the product.\n\n3.Please complete, Business Reply Form, as an acknowledgement of this notice and return the completed form via email to CommunicationsRA1@stryker.com. Response is required.\n\n4. A representative will contact affected accounts to schedule a field service visit to complete an inspection and replacement of the affected component.\n\n5. Maintain awareness of this communication internally until all required actions have been completed within your facility.\n\n6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.",
      "product_quantity": "6170 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
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        "device_name": "Light, Surgical, Ceiling Mounted",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4580",
        "device_class": "2"
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