Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sen...
FDA Device Recall #Z-2574-2026 - Class II, May 27, 2026
Recall Summary
| Recall Number | Z-2574-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 27, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Dexcom, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | N/A |
Product Description
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 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.
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. 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.
Lot / Code Information
Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002
Other Recalls from Dexcom, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2165-2026 | Class II | Brand Name: Dexcom ONE+ Continuous Glucose Moni... | Apr 14, 2026 |
| Z-2163-2026 | Class II | Brand Name: Dexcom G7 Continuous Glucose Monito... | Apr 14, 2026 |
| Z-2164-2026 | Class II | Brand Name: Dexcom G7 Continuous Glucose Monito... | Apr 14, 2026 |
| Z-0318-2026 | Class I | Brand Name: Dexcom G6 Continuous Glucose Monito... | Aug 28, 2025 |
| Z-2450-2025 | Class I | Brand Name: Dexcom ONE+ Continuous Glucose Moni... | Jul 24, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.