Dexcom, Inc.: Integrated Continuous Glucose Monitoring System, Factory Calibrated
Dexcom G7 continuous glucose monitoring sensors from two specific lots were stolen during a destruction process and sold unauthorized to pharmacies and distributors. One lot was designated for destruction due to inadequate sterilization, creating an infection risk, while the other lot had potential sensor reading failures or inaccuracies that could lead to missed high blood sugar readings and incorrect treatment decisions. These sensors were distributed to users in the United States and multiple other countries, with unknown storage conditions during their unauthorized distribution.
- Recalling firm
- Dexcom, Inc.
- 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...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-27
- Status
- Open, Classified
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/976f704c-6a3f-4bdc-aae5-9ee61367ea42