The Dexcom G6 is a continuous glucose monitoring (CGM) system marketed for its ease of use and ability to eliminate fingersticks. However, serious reliability concerns triggered recalls and a class-action lawsuit.
Patients were first notified in May 2025 through an Urgent Medical Device Correction notification issued by the manufacturer. The notice warned that certain Dexcom G6 and G7 receivers were failing to provide audio alerts for low or high glucose levels. This was followed by an update in June 2025, when the FDA classified the issue as a Class I recall—the agency's most serious designation.
By the time the correction was issued, over 100 complaints had been filed, including 56 reports of severe adverse events. Documented injuries linked to these defects include seizures, loss of consciousness, vomiting, and other complications from severe hypoglycemia or hyperglycemia.
At Wisner Baum, our attorneys are helping people understand their legal rights following the Dexcom G6 recall. If you believe your device was affected, contact us today to see if you qualify for the Dexcom class action lawsuit.
What Is Dexcom G6?
The Dexcom G6 is a small, wearable continuous glucose monitoring (CGM) system. The monitor is worn for up to 10 days and sends glucose to a smartphone or Dexcom receiver. While Dexcom’s marketing claims the device eliminates the need for fingersticks, the manufacturer acknowledges that fingersticks are still required “if symptoms or expectations do not match readings.”
Is There a Dexcom G6 Lawsuit?
Yes. After users began experiencing adverse health events related to failures in the G6 continuous glucose monitoring system, a Dexcom lawsuit was filed. The class action lawsuit asserts that the Dexcom G6 and G7 CGM devices were adulterated after FDA approval with unapproved materials. The lawsuit further alleges that the adulteration causes the devices to fail, resulting in injury to patients who use them to make critical diabetes treatment decisions.
Reports from patients who used the Dexcom G6 say their readings were inaccurate and that delayed or inaudible alerts caused serious harm. Lawsuits further allege device failures can cause serious adverse events, including hospitalization related to hypo- or hyperglycemia.
Why Was the Dexcom G6 Recalled?
The Dexcom G6 has been the subject of two major recalls. The most recent was a Class I recall, the most serious issued by the US Food and Drug Administration (FDA). The FDA issues Class I recalls only when there is a “reasonable probability” that using the device could cause serious adverse health consequences or death.
The most recent Dexcom G6 recall addresses a hardware defect where the receiver’s speaker may fail to sound an alarm for dangerous blood sugar levels. This silence can be deadly for patients who rely on the device to wake them or alert them during a medical emergency.
History of Dexcom Recalls
First Dexcom G6 Recall (2020)
The first major Dexcom G6 recall came in March 2020. Dexcom notified users through an Urgent Medical Device Correction that hydroxyurea, an anti-neoplastic drug used in chemotherapy and the treatment of sickle cell disease, could adversely interact with the device.
The drug caused falsely elevated glucose readings, potentially masking low blood sugar (hypoglycemia). The FDA designated this a Class II recall, meaning that use of the product may cause “temporary or medically reversible adverse health consequences” or the chances of a serious injury are remote.
Dexcom G6 Receiver Recall (2025)
In June 2025, the FDA announced a Class I recall of certain Dexcom G6, G7, ONE, and ONE+ receivers because defective foam or an assembly error could cause the receiver speaker to lose contact with the printed circuit board, potentially preventing audible alerts for dangerously low or high blood glucose levels.
Injuries potentially caused by the Dexcom G6 receiver defect include:
- Seizures
- Vomiting
- Loss of consciousness
- Death (No deaths have been reported as of Dec. 2025)
Why Dexcom Recalls Keep Happening
The FDA identified several crucial safety lapses in its March 4, 2025, Warning Letter to Dexcom. These safety issues, identified by the FDA and referenced in lawsuits, include:
Unauthorized Design Changes: Dexcom made significant modifications to the materials used in its G6 and G7 CGM sensors without obtaining the required premarket approval from the FDA. Internal studies showed these modified sensors had “significantly greater variability,” leading to unreliable and potentially dangerous glucose readings.
Quality System Violations: FDA inspections of Dexcom's manufacturing facilities in two states revealed the company's methods and controls were not in conformity with federal good manufacturing practices (Quality System regulation).
Inadequate Validation and Procedures: The FDA warning letter noted that Dexcom failed to establish adequate procedures for evaluating and validating design changes before implementing them. The company also failed to properly validate its manufacturing process for key measurements.
Failure to Track Materials: Inspectors noted that the company's quality systems lacked a formal requirement for tracking certain material concentrations (like acetaminophen, which can interfere with readings) in test runs.
Concealing Defects (Alleged in Lawsuits): Wisner Baum’s class action lawsuit against Dexcom alleges the company knew about defects and accuracy issues but continued to market its products as reliable and safe, downplaying the risks to patients.
Dexcom G6 Recall Response
Dexcom continues to promote its devices as safe despite problems highlighted in the recent recall and in legal documents filed nationwide. While the medical device company responded to the FDA investigation into its adulterated sensors, the FDA found its responses inadequate. Dexcom is now facing a class-action lawsuit over device failures and other issues.
How to Check If Your Device is Affected by the Recall
Dexcom G6 users can check if their receiver was part of the recall by inputting the serial number on Dexcom's website. If the receiver was part of the recall, G6 users should contact Dexcom Technical Support at 1-844-478-1600 to coordinate the return and replacement of the device.
The manufacturer recommends that all G6 users, even those not affected by the recall, regularly test the speaker function every time they charge the receiver.
What Users Should Do if Their Dexcom G6 Was Recalled
If your Dexcom G6 device was recalled, you should contact Dexcom Technical Support at 1-844-478-1600 to receive a replacement. Individuals are also encouraged to report adverse reactions or device malfunctions to MedWatch. MedWatch is the FDA’s Safety Information and Adverse Event Reporting Program. It helps to track problems with medical devices.
If the glucose readings from your Dexcom G6 do not reflect symptoms or expectations, you should use a backup glucose monitoring system to confirm results. It is essential to report any new or worsening symptoms, as well as any device problems, to your healthcare provider. If you suffer harm after a Dexcom G6 failure, you may be entitled to compensation and are encouraged to speak with a Dexcom lawsuit attorney as soon as possible.
Contact a Dexcom Lawsuit Lawyer
If you have experienced inaccurate readings or a malfunction from a Dexcom G6 device that resulted in injury, you may be entitled to compensation. The medical device injury lawyers at Wisner Baum are currently accepting claims related to Dexcom device failures.
Our firm is here to help you understand your rights and fight to ensure justice is served. Contact our office today to schedule a free, no-obligation consultation to determine if you qualify for a Dexcom lawsuit.
