ClearanceBrief
Recall Z-2574-2026 ยท QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated

Dexcom, Inc.

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

DateJun 24, 2026 (initiated May 27, 2026)
StatusOpen, Classified
ReasonCertain 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 inco
Root causeNonconforming 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. Determin
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 start
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K240902Dexcom G7 Continuous Glucose Monitoring System
Dexcom, Inc., Apr 23, 2024