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U.S. Department of Health and Human Services

Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring System

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 Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring Systemsee related information
Date Initiated by FirmMay 27, 2026
Date PostedJune 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2574-2026
Recall Event ID 98968
510(K)NumberK240902 
Product Classification Integrated Continuous Glucose Monitoring system, factory calibrated - Product Code QBJ
ProductBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
Code Information Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002
FEI Number 3004753838
Recalling Firm/
Manufacturer		 Dexcom, Inc.
6340 Sequence Dr
San Diego CA 92121-4356
For Additional Information ContactAvi Brown
1-858-2817153
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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. For Patients/Healthcare Providers: 1. 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). 2. 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. 3. 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. 4. 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. 5. Contact healthcare provider if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site. Independent Pharmacies: Check 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.
DistributionDexcom 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. Based on App user performance data, Lot 1725204004 has sensor session starts in the United States. Based 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QBJ
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