Recall archive / FDA device enforcement
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pac... — FDA record Z-2574-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 27, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Dexcom, Inc.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2574-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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. 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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 1, 2026
- Recall initiation date
- May 27, 2026
- Center classification date
- Jun 24, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.