{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "213506",
      "product_res_number": "Z-1943-2025",
      "event_date_initiated": "2025-05-12",
      "event_date_posted": "2025-06-16",
      "recall_status": "Open, Classified",
      "res_event_number": "96743",
      "product_code": "QBJ",
      "k_numbers": [
        "K223931"
      ],
      "product_description": "Dexcom G6 Glucose Receiver, SKUs (Part Number):   STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)",
      "code_info": "All Lots/\nUDI:  STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225",
      "firm_fei_number": "3004753838",
      "recalling_firm": "Dexcom, Inc.",
      "address_1": "6340 Sequence Dr",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4356",
      "additional_info_contact": "Dexcom Technical Support\n1844-478-1600",
      "reason_for_recall": "Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On May 12, 2025, Dexcom issued a \"Urgent: Medical Device Correction\" Notification to affected consignees via E-Mail. On June 9, 2025, Dexcom issued an Urgent: Medical Device Correction update Dexcom asked consignees to take the following actions:\n\n1. Verify if your receiver is affected by this issue: Check the serial number for any receiver(s) you use: https://dexcom.com/en-us/checkreceiver\n\n2. If your receiver is affected, contact Dexcom Technical Support at 1-844-478-1600 to coordinate return of the affected receiver and a no charge replacement.\n\n3. Whether or not your receiver is affected by this notification, Dexcom continues to recommend regular testing of the speaker. Test speaker function every time you charge your receiver. When you charge, a reminder prompt will invite you to test speaker function.\n \n4.If you need assistance related to this issue or notification, please call Dexcom Technical Support at 1- 844-478-1600. Technical Support is available 24 hours a day/7 days a week to assist you.",
      "product_quantity": "36,824 units",
      "distribution_pattern": "worldwide distribution - US Nationwide and the countries of  Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.",
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          "K222447",
          "K253710",
          "K200876",
          "K261402",
          "K223435",
          "K243214"
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        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1355",
        "device_class": "2"
      }
    }
  ]
}