Dexcom G7 Glucose Monitor Faces Legal Scrutiny Over Safety and Accuracy Concerns
October 17, 2025 — Medical device manufacturer Dexcom is confronting mounting legal and regulatory challenges over its G7 continuous glucose monitor (CGM), with a federal class action lawsuit and serious FDA violations raising questions about patient safety.
Federal Lawsuit Alleges Dangerous Defects
A class action lawsuit filed in the U.S. District Court for the Central District of California accuses Dexcom of falsely marketing the G7 as a superior and highly accurate glucose monitoring system while concealing significant defects from users.
According to the complaint, patients have experienced:
- Dangerous alert failures that could leave diabetics unaware of critical blood sugar changes
- Inaccurate glucose readings that could lead to improper insulin dosing
- Dramatically shortened device lifespans, with some sensors failing after just two days of use
- Difficulty obtaining timely replacements from the company
The lawsuit’s allegations have been partially validated by an FDA Class I recall—the agency’s most serious classification, reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
FDA Cites Unauthorized Design Changes
On March 4, 2025, the Food and Drug Administration issued a warning letter to Dexcom detailing multiple violations related to the G7 device. The FDA’s investigation uncovered that Dexcom made unapproved design changes to the sensor without obtaining required regulatory clearance.
Most critically, the company altered a sensor coating without FDA authorization, resulting in greater variability in accuracy—a particularly dangerous issue for patients who rely on the G7’s readings for automated insulin dosing systems.
The FDA determined that G7 devices are both misbranded and adulterated due to these unauthorized modifications, directly contradicting Dexcom’s marketing claims about the device’s accuracy and reliability. The agency also cited inadequate manufacturing monitoring and insufficient risk analysis in its warning letter.
Growing Legal Action
Multiple law firms are now actively recruiting affected G7 users for participation in class action and product recall lawsuits. The legal actions focus on the company’s alleged failure to disclose known defects and the potential health risks posed by the device’s accuracy problems.
For diabetic patients who depend on continuous glucose monitors to make life-or-death decisions about insulin dosing, the accuracy and reliability of these devices is not merely a matter of convenience—it’s a critical safety issue that can have immediate and severe health consequences.
Dexcom has not yet publicly responded to requests for comment on the lawsuit or the ongoing regulatory issues.