Dexcom G6 & G7 Lawsuit (2026): Recalls, FDA Warnings & Settlements

Who Qualifies for a Dexcom Lawsuit

• Used a Dexcom G6 or G7 Continuous Glucose Monitoring (CGM) system;
• Device provided inaccurate glucose readings that led to improper insulin dosing;
• Experienced device failures, including missed alerts, delayed alerts, or complete system malfunctions;
• Suffered severe hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar) due to device malfunction;
• Experienced serious health complications including seizures, loss of consciousness, diabetic ketoacidosis (DKA), coma, or hospitalization;
• Suffered severe allergic reactions, skin infections, or scarring at sensor insertion sites;
• Family members of individuals who died due to Dexcom device failure (wrongful death claims);
• Have medical records documenting the device malfunction and resulting injuries;
• Within your state's statute of limitations (typically 2-4 years from injury or discovery).

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What is Dexcom CGM?

Dexcom Continuous Glucose Monitoring (CGM) systems are wearable medical devices designed to help people with diabetes track their blood glucose levels in real-time without frequent fingerstick tests. The system consists of a small sensor inserted under the skin, a transmitter that sends glucose data wirelessly, and either a dedicated receiver device or smartphone app that displays readings and issues alerts.

Dexcom G6: FDA-approved in 2018, the G6 was marketed as providing accurate glucose readings every five minutes and alerting users when blood sugar became dangerously low or high. The device was widely adopted and integrated with insulin pumps for automated insulin dosing decisions.

Dexcom G7: Launched as Dexcom's next-generation CGM with a smaller form factor, faster warm-up time, and advertised 10-day wear period. The G7 was meant to improve upon the G6 with enhanced accuracy and user experience.

The Critical Problem: Patients and medical professionals relied on Dexcom's CGM systems to make life-or-death insulin dosing decisions. When the devices provided inaccurate readings or failed to alert users about dangerous glucose levels, the consequences were often catastrophic — including seizures, diabetic comas, and deaths. The FDA received over 500,000 adverse event reports related to Dexcom G6, with 13 fatalities documented.

Unauthorized Modifications: In March 2025, the FDA issued a warning letter revealing that Dexcom made unauthorized changes to critical sensor components without required approval. Internal Dexcom studies showed these modified sensors had "significantly greater variability" than approved sensors, causing higher risks for users making insulin dosing decisions. Similar patterns of corporate negligence have been seen in other defective medical device cases.

Dexcom Recalls & FDA Actions

Dexcom continuous glucose monitors have been subject to multiple FDA recalls and regulatory actions revealing serious safety defects:

June 2025 - Class I Recall (Most Serious):

• Over 600,000 Dexcom G6, G7, ONE, and ONE+ receivers recalled worldwide
• Defective foam or assembly errors caused receiver speakers to lose contact with circuit boards
• Devices failed to provide audible alerts for dangerously low or high glucose levels
• 56 injuries reported including seizures, loss of consciousness, and vomiting
• No deaths reported in this specific recall, but potential for fatal consequences acknowledged

September 2025 - Second Class I Recall:

• Additional recall for sensor failed alerts and other system malfunctions
• FDA classified as Class I due to serious risk of injury or death

January 2025 - G6 Touchscreen Receiver Recall:

• Software design flaws caused delayed or missed glucose alerts
• Affected G6 receivers with .NET operating system
• Software updates provided to resolve issues

March 2025 - FDA Warning Letter (Critical):

• FDA cited Dexcom for "adulteration" of G6 and G7 devices due to quality system failures
• Unauthorized design changes made to critical sensor components without FDA approval
• Dexcom's own clinical studies showed modified sensors had "significantly greater variability"
• FDA stated: "The larger inaccuracies in coated sensors cause higher risks for users who rely on the sensors to dose insulin"
• Inadequate monitoring of glucose and acetaminophen concentrations during manufacturing
• Failed design validation and incomplete risk assessments
• Multiple violations of good manufacturing practices

Pattern of Recurring Defects: The 2025 recalls follow previous Class I recalls in 2019 for similar G6 receiver alarm failures, demonstrating a pattern of recurring safety defects in Dexcom's alert systems spanning multiple years and device generations.

Dexcom G6 Production Ending: In December 2025, Dexcom announced it will cease G6 production by July 1, 2026, though the timing coincides with mounting lawsuits and recalls.

Dexcom Device Complications & Injuries

Patients using Dexcom G6 and G7 CGM systems have reported severe and life-threatening complications:

Critical Alert Failures:

• Missed low glucose alerts leading to severe hypoglycemia
• Missed high glucose alerts leading to dangerous hyperglycemia
• Delayed alerts that arrived too late to prevent medical emergencies
• Complete system malfunctions with no alerts functioning
• Silent failures where device appeared to work but wasn't alerting

Inaccurate Glucose Readings:

• False high readings causing users to administer too much insulin
• False low readings causing users to consume excess sugar
• Readings that didn't match fingerstick tests by dangerous margins
• Erratic readings showing rapid glucose swings that weren't occurring
• Sensor failures showing "sensor error" messages during critical moments

Severe Medical Consequences:

• Hypoglycemic emergencies: Seizures, loss of consciousness, coma, brain damage
• Hyperglycemic crises: Diabetic ketoacidosis (DKA), dangerously elevated blood sugar over 1,000 mg/dL
• Cardiovascular events: Heart attacks triggered by severe glucose imbalances
• Hospitalization: Emergency treatment required for life-threatening glucose levels
• Vehicle accidents: Crashes caused by hypoglycemic episodes while driving
• Permanent injuries: Long-term complications from repeated severe glucose episodes
• Death: At least 13 deaths linked to Dexcom G6 failures documented by FDA

Skin Reactions and Local Complications:

• Severe allergic reactions at sensor insertion sites
• Painful blistering and scarring
• Infections requiring antibiotic treatment
• Skin irritation preventing continued device use

Psychological and Quality of Life Impact:

• Anxiety and fear related to device reliability
• Post-traumatic stress from medical emergencies
• Loss of confidence in diabetes management
• Need for constant vigilance and backup fingerstick testing

Dexcom Lawsuit Settlement Ranges & Factors

If you're wondering how much Dexcom lawsuit settlements might be worth, settlement values will vary significantly based on the severity of injuries and individual circumstances. Based on expert analysis and similar medical device litigation:

• Predicted settlement range: $100,000 to $5 million+ per case, depending on severity of injuries and whether death occurred;
• Wrongful death cases: Highest settlement values, potentially $2-5 million or more, especially where device failure directly caused death;
• Permanent injury cases: $500,000 to $2 million for cases involving permanent brain damage, organ damage, or disabilities from severe hypoglycemic or hyperglycemic episodes;
• Hospitalization cases: $100,000 to $500,000 for cases requiring emergency treatment, ICU stays, or multiple hospitalizations;
• Moderate injury cases: $50,000 to $150,000 for documented device failures causing seizures or serious complications without permanent injury;
• Class action refunds: September 2025 class action seeks refunds for all purchasers of defective G6 and G7 devices, alleging false and misleading marketing;
• Investor securities lawsuit: Separate securities class action filed on behalf of Dexcom shareholders for losses between July 2024 and September 2025;
• No global settlement yet: Dexcom has not agreed to a settlement program, but mounting lawsuits, FDA actions, and recalls increase pressure to settle;
• Factors affecting settlement value:
  • Severity of injuries (death, permanent disability, hospitalization);
  • Number and duration of device malfunctions;
  • Whether malfunction was part of recalled batch;
  • Medical expenses and future care needs;
  • Lost wages and diminished earning capacity;
  • Pain and suffering, emotional distress;
  • Impact on quality of life and daily functioning;
  • Strength of medical documentation linking device failure to injury;
  • Whether FDA violations apply to your device;
  • Punitive damages potential for willful misconduct;
  • State-specific laws and jury sympathy.

Disclaimer: Settlement ranges are predictions based on expert analysis and similar medical device litigation. Actual outcomes depend on case-specific facts and circumstances.

Deadlines for Filing a Dexcom Lawsuit

Each state has statutes of limitations that set strict deadlines for filing a Dexcom CGM lawsuit. For medical device product liability claims, deadlines typically range from 2 to 4 years depending on the state, and the clock usually starts when you discovered (or reasonably should have discovered) that the device caused your injuries.

Discovery Rule: Many states apply a "discovery rule" for medical device cases, meaning the statute of limitations begins when you knew or should have known that your injuries were caused by a defective device. The 2025 FDA recalls and warning letter may serve as key dates establishing when patients became aware of widespread device problems.

Wrongful Death Claims: For families pursuing wrongful death lawsuits, deadlines are typically 1 to 3 years from the date of death, varying by state. These deadlines are strictly enforced.

Act Quickly: Even if you believe you're within the statute of limitations, it's critical to consult with a Dexcom lawsuit attorney as soon as possible. Evidence must be gathered, medical records obtained, and expert witnesses retained — all of which takes time. Waiting too long can weaken your case or cause you to miss important deadlines.

Preserve Evidence: If you still have your defective Dexcom device, receiver, or sensor, preserve it as evidence. Take screenshots of error messages, inaccurate readings, or failed alerts. Keep all medical records documenting your injuries and hospitalizations.

Dexcom Lawsuit Updates™

Last updated February 2026.

• January 2026: FDA flags serious software issue in Dexcom glucose monitoring app, raising additional concerns about device reliability beyond hardware failures. Software defects cited as contributing to inaccurate readings and suppressed or failed alerts.
• December 2025: Dexcom announces G6 production will cease July 1, 2026, recommending users upgrade to G7 or G7 15 Day. Timing coincides with mounting lawsuits and regulatory scrutiny. Company faces questions about why problematic G6 is being discontinued amid litigation.
• October 2025: Class action lawsuit filed demanding jury trial for claims that Dexcom's G7 representations were false, misleading, and deceptive. Lawsuit alleges G7 places users at risk of severe hypoglycemia, hyperglycemia, seizure, coma, or death due to design defects and software failures.
• September 2025: Wisner Baum files class action against Dexcom in U.S. District Court for Southern District of California on behalf of consumers who purchased defective G6 and G7 devices. Class action seeks refunds and damages for false advertising.
• September 2025: Second Class I recall issued by FDA for additional G7 sensor failures and alert malfunctions, demonstrating ongoing and widespread device problems beyond initial June recall.
• July 2025: FDA publicly announces Class I recall affecting over 600,000 Dexcom G6, G7, ONE, and ONE+ receivers worldwide due to speaker malfunctions preventing critical glucose alerts. Recall follows June notification to affected customers.
• June 2025: Dexcom issues Urgent Medical Device Correction notification warning that certain G6 and G7 receivers fail to provide audio alerts for dangerous glucose levels. Over 100 complaints filed, including 56 reports of severe adverse events such as seizures and loss of consciousness.
• May 2025: Dexcom first notifies patients through Urgent Medical Device Correction about defective receivers failing to alert users. Company begins coordinating free replacements for affected devices.
• March 2025: FDA issues formal warning letter to Dexcom citing "adulteration" of G6 and G7 devices due to unauthorized modifications of critical sensor components without FDA approval. FDA reveals Dexcom's own studies showed modified sensors had "significantly greater variability" causing higher risks for insulin dosing decisions. Warning letter details multiple quality system violations and good manufacturing practice failures.
• January 2025: Recall issued for G6 touchscreen receivers with .NET operating system due to software design flaws causing delayed or missed glucose alerts. Software updates provided to resolve issues.
• April 2024: Tennessee widow files wrongful death lawsuit against Dexcom and Tandem Diabetes Care after husband died while using Dexcom monitor. Lawsuit names both device manufacturers as defendants.
• 2024: California plaintiffs file lawsuits alleging G6 and G7 devices repeatedly failed to provide accurate readings and that Dexcom engaged in misleading advertising about device reliability and accuracy.
• November 2025: Securities class action filed on behalf of Dexcom investors who purchased stock between July 26, 2024 and September 17, 2025, alleging company made false statements about device safety and quality.
• Ongoing: Individual wrongful death and personal injury lawsuits continue to be filed across the United States. FDA continues monitoring Dexcom's corrective actions and compliance with manufacturing standards.

We update this section monthly with recall developments, FDA actions, trial outcomes, new filings, and settlement negotiations.

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How the Dexcom Lawsuit Process Works

If you're wondering how to file a Dexcom CGM lawsuit, the process typically follows these steps:

1. Free confidential case review: Contact a Dexcom lawsuit attorney who will evaluate your case at no cost. Most attorneys handle these cases on contingency, meaning no fees unless you win;
2. Medical record review and evidence gathering: Legal team collects medical records documenting device use, glucose readings, alert failures, hospitalizations, and injuries. Attorneys obtain device serial numbers to determine if your device was part of recalled batches;
3. Preserve device and documentation: If you still have your Dexcom device, receiver, or sensors, preserve them as evidence. Take screenshots of error messages and inaccurate readings. Keep all medical bills and records;
4. Expert witness evaluation: Medical experts and device engineers review your case to establish causation between device failure and your injuries. Experts may analyze device data logs and compare to medical records;
5. Filing the lawsuit: Attorney files your product liability claim in appropriate state or federal court. Claims may include design defect, manufacturing defect, failure to warn, negligence, and breach of warranty;
6. Discovery phase: Both sides exchange evidence including Dexcom's internal communications, design documents, testing data, FDA submissions, post-market surveillance reports, and documents showing what the company knew about device failures;
7. Class action participation or individual claim: You may join existing class actions for refunds or pursue individual injury claims for higher compensation. Wrongful death claims are always individual cases;
8. Settlement negotiation or trial: Many medical device cases settle after discovery reveals company knowledge of defects. If settlement cannot be reached, case proceeds to trial where jury determines compensation. Similar litigation strategies are used in other device failure cases like Bard PowerPort lawsuits and Cartiva implant litigation.

Throughout the process, experienced Dexcom attorneys work on contingency, meaning you pay nothing unless you win your case. All communications remain confidential, and attorneys understand the sensitive nature of medical device injury claims involving chronic conditions like diabetes.

Dexcom Lawsuit FAQs

Sources & FDA Documents

• U.S. Food and Drug Administration (FDA) — regulatory oversight, warning letters, and recall information
• FDA MAUDE Database — adverse event reports for Dexcom devices
• FDA Medical Device Recalls — official recall notices and classifications
• Dexcom, Inc. — manufacturer information and device correction notices
• American Diabetes Association — diabetes management resources and CGM information