{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220303", "product_res_number": "Z-2574-2026", "event_date_initiated": "2026-05-27", "event_date_posted": "2026-06-24", "recall_status": "Open, Classified", "res_event_number": "98968", "product_code": "QBJ", "k_numbers": [ "K240902" ], "product_description": "Brand Name: Dexcom G7 Continuous Glucose Monitoring System\r\nProduct Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack\r\nModel/Catalog Number: STP-AT-012\r\nSoftware Version: N/A\r\nProduct Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack\r\nComponent: Dexcom G7 Continuous Glucose Monitoring System", "code_info": "Lot Code: UDI-DI: 00386270004109\rLot Numbers: 1725204004 and 1725069002", "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": "Avi Brown\n1-858-2817153", "reason_for_recall": "Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.", "root_cause_description": "Nonconforming Material/Component", "action": "On 05/26-27/2026, the firm issued a Press Release and sent an \"URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION\" informing customers and the public that Dexcom is aware that two lots (1725204004 and 1725069002) of Dexcom G7 sensors, originally designated as scrap and intended for destruction, were stolen and distributed.\n\nFor Patients/Healthcare Providers:\n1. Check lot number on G7 sensor outer box and compare with the listed lot numbers in this notification. If the lot number is listed, the device is affected. If affected, skip to step 3 below to document affected serial number(s).\n2. Determine if current or unused sensor(s) is affected based on serial number by visiting www.dexcom.com/theft-check and enter serial number into the serial number look-up. Reference https://www.dexcom.com/faqs/how-to-find-dexcom-g7-serial-number for instructions.\n3. If you have affected product(s), immediately discontinue use and dispose of them. Contact Dexcom Technical Support at 1-844-478-1600 with questions or to request a no-cost replacement. Important: Keep record of affected serial number for traceability purposes This is required to confirm no cost replacement.\n4. Replace the affected sensor with an unaffected sensor for glucose monitoring. If you do not have an unaffected G7 sensor, use a blood glucose meter for treatment decisions until you receive a replacement sensor.\n5. Contact healthcare provider if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site.\n\nIndependent Pharmacies:\nCheck inventory if purchased G7 sensors from Pharmsource, LLC. If you have product from the lots listed, immediately dispose of the product. Contact Dexcom with any related inquiries at inquiries@dexcom.com.", "distribution_pattern": "Dexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App user performance data.\n\nBased on App user performance data, Lot 1725204004 has sensor session starts in the United States.\n\nBased on App user performance data, Lot 1725069002 has sensor session starts in the United States and the countries of Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates,and the United Kingdom.", "openfda": { "k_number": [ "K213919", "K231081", "K201328", "K240902", "K253737", "K223931", "K222447", "K253710", "K243214", "DEN170088", "K221259", "K223435", "K233537", "K200876", "K261402", "K191450", "K183206", "K234133" ], "registration_number": [ "3011120183", "3012448339", "2032098", "3033394445", "3012302888", "3009888344", "2954323", "2024024", "3008717264", "3004753838", "3004105270", "3016904853", "1450743", "3006371704", "3009901017", "3006537560", "3027503105", "3004111573", "3002807314", "3013820501", "3013435121", "2030598", "9710492", "3011536730", "2029015", "3010220595", "3019807891", "3003600763", "3037326582", "3038285067", "3007421145", "3002807090", "3021611414" ], "fei_number": [ "3011120183", "3012448339", "3033394445", "3012302888", "3006003617", "3009888344", "2024024", "3008717264", "3004753838", "3004105270", "3016904853", "1450743", "3006371704", "3009901017", "3006537560", "1000518731", "3027503105", "3004111573", "3003058448", "3004173703", "3002807314", "3013820501", "3013435121", "1000160458", "3011536730", "3010220595", "3019807891", "3003600763", "3037326582", "3038285067", "3002803444", "3003500908", "3021611414" ], "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1355", "device_class": "2" } } ] }