FDA recall notice
Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and…
FDA Recall Confirmed · Glucose Monitors · posted Sep 12, 2025
Key facts
| Notice | Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure |
|---|---|
| Device type | Glucose Monitors |
| Status | Recall Confirmed |
| Posted | Sep 12, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- 1–9 Recall events referenced
- None UDI device identifiers named
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall notices and early alerts
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date: