Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack
Summary
The FDA issued a Class II for Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom by Dexcom, Inc.. Reason: Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors.
Details
Source
Device Recall
External ID
Z-2574-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002
Quantity Affected: N/A
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-27
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 286 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Dexcom, Inc. has 33 FDA actions in our database, including 18 recalls and 15 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dexcom, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dexcom, Inc. have FDA actions?
Dexcom, Inc. has 33 FDA actions in our database, including 18 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2574-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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