Dexcom G7 Lawsuit Problems: Recalls, FDA Warning, Class Actions

The Dexcom G7 lawsuit landscape now includes a consolidated consumer class action in federal court in Southern California, a wrongful death suit in Tennessee, and a securities fraud case in New York. All of them trace back to the same underlying allegation: that Dexcom quietly changed a key sensor material in December 2023 without FDA clearance, kept marketing the G7 as its most accurate monitor, and exposed users to missed alerts and inaccurate readings.¹²

Here is what each case claims, who can be part of it, and where things stand as of mid-2026.

What the Lawsuits Say Dexcom Did Wrong

In December 2023, Dexcom switched to an in-house formulation for the membrane coating in the sensor’s resistance layer, replacing a component it had previously bought from an outside supplier. The original G6 and G7 sensors had been cleared by the FDA under 510(k) notifications K182041 and K213919, and those clearances rested on clinical data using the original material.¹

The FDA later concluded that the change could significantly affect the device’s safety or effectiveness, which meant Dexcom was required to file a new 510(k) at least 90 days before shipping the modified sensors. Dexcom did not do that. Internal Dexcom studies referenced in FDA inspection records showed the new material performed worse “by every accuracy metric,” with “significantly greater variability” and “larger inaccuracies” than the original.³¹

Dexcom disputes the FDA’s characterization. Company spokesperson Nadia Conard said the change amounted to qualifying “a second source for one of its raw materials” and that “extensive testing” confirmed the material met specifications. Dexcom says it treated the change as non-significant under FDA guidelines and notified the agency both informally and through later 510(k) submissions.⁴ The company stopped using the in-house material and reverted to the original supplier rather than seek clearance for the modified version.⁵

The Consumer Class Action: Grisoli and Levens

Two proposed class actions were filed in federal court in the fall of 2025 and have since been consolidated. This is the case most G7 users are asking about.

Levens et al. v. Dexcom, Inc. (Case No. 3:25-cv-02565-BEN-BLM) was filed September 29, 2025, in the Southern District of California by the law firm Wisner Baum on behalf of Caroline Levens and Gisell Cordova Regis. It covers both G6 and G7 devices and alleges Dexcom manufactured them with unapproved materials, making them “adulterated and misbranded under federal law.” The complaint asserts federal warranty claims under the Magnuson-Moss Act, plus California’s Consumer Legal Remedies Act, the Song-Beverly Consumer Warranty Act, and state unfair competition and false advertising laws.⁶

Grisoli v. Dexcom was filed October 13, 2025, in the Central District of California by Kelly Grisoli, a parent of a child with Type 1 diabetes. The complaint alleges the G7 was “defective, prone to dangerous alert failures, and subject to recall,” and that sensors sometimes failed after two days despite being marketed for 10-day wear. It brings claims under the California Consumer Legal Remedies Act, the Unfair Competition Law, and the False Advertising Law.²

Grisoli was transferred to the Southern District of California in December 2025, and on May 15, 2026, the court consolidated the two cases.⁷ Competing motions to appoint interim class counsel are pending, and Dexcom’s deadline to respond to the complaints has been stayed. No class has been certified, no motion to dismiss has been ruled on, and no trial date has been set.⁸

Practically, that means anyone who bought or used a G6 or G7 sensor during the relevant period is a potential class member, but there is nothing to sign up for yet. If a class is eventually certified, notice goes out to affected users; until then, individuals who believe they were harmed can contact plaintiff’s counsel directly or wait for that notice.

The Wrongful Death Case

Users who lost a family member may have a separate individual claim rather than a class claim. Wisdom-Schepers v. Dexcom Inc. and Tandem Diabetes Care Inc., removed to the Eastern District of Tennessee in November 2025, is the wrongful death case that has been publicly reported. The complaint alleges that Michael Schepers’s G7 displayed normal glucose readings between 68 and 120 mg/dL while his actual blood sugar had exceeded 1,600 mg/dL. He died April 3, 2024, from cerebral edema caused by an anoxic brain injury following cardiac arrest, with complications including diabetic ketoacidosis, hyperkalemia, and acute kidney failure. His spouse’s suit brings strict product liability claims for design defect, failure to warn, misrepresentation, and wrongful death.⁹

Investigative reporting by Hunterbrook Media identified at least 13 deaths among G7 users since the device’s 2023 launch, based on reports to the FDA’s MAUDE adverse-event database naming Dexcom as the manufacturer and the G7 as the product. Three more deaths were reported to the FDA in September 2025 alone.¹⁰ MAUDE reports do not establish that a device caused a death, and in at least one case the probable cause “could not be determined.”¹¹

The Investor Case

Dexcom shareholders also have their own litigation. After Hunterbrook published its investigation in September 2025, Dexcom’s stock fell $8.99 per share, nearly 12% over two trading sessions, closing at $67.45 on September 19, 2025.¹²

Several securities fraud suits followed, including Prime v. DexCom, Inc. (No. 25-cv-08912, S.D.N.Y.), Oakland County Employees Retirement System v. DexCom (No. 25-cv-09370, S.D.N.Y.), and Boston Retirement System v. DexCom (No. 25-cv-03284, S.D. Cal.). They allege violations of Sections 10(b) and 20(a) of the Securities Exchange Act, claiming Dexcom concealed the unauthorized design change and overstated the accuracy of its devices during a class period running from January 8, 2024, through September 17, 2025.¹²

Union Asset Management Holding AG was appointed lead plaintiff in the consolidated Southern District of New York action in January 2026, and an amended consolidated complaint was filed April 10, 2026, before Judge Katherine Polk Failla. No motion to dismiss schedule has been publicly reported.¹³ Only Dexcom shareholders who bought during the class period are eligible.

The FDA Warning Letter and Recalls Backing the Claims

Two regulatory actions give the lawsuits their factual scaffolding. On March 4, 2025, the FDA issued Warning Letter CMS# 700835 to Dexcom after inspections at its San Diego headquarters and Mesa, Arizona plant. The letter declared both the G6 and G7 monitors “adulterated” and “misbranded” under federal law, cited inadequate process validation, deficient design controls, and a failure to investigate manufacturing issues involving dissolved oxygen content in G6 sensors, and warned that noncompliance could lead to seizures, injunctions, and civil penalties.¹

Two Class I recalls followed, the FDA’s most serious category. In May 2025, Dexcom recalled more than 700,000 handheld receivers used with the G7, G6, ONE, and ONE+ systems, including 602,445 G7 receivers, after defective foam or assembly errors caused internal speakers to lose contact with the circuit board and silence low- and high-glucose alerts. The FDA elevated the recall to Class I in June 2025 after 112 complaints worldwide, including 56 reports of serious adverse events such as seizures, loss of consciousness, and vomiting tied to undetected glucose extremes.¹⁴¹⁵

In July 2025, a second Class I recall targeted the G7 and ONE+ smartphone apps. A software design defect meant the apps failed to alert users when a sensor unexpectedly stopped working. The recall covered 907,842 units and required a mandatory app update, with affected versions scheduled to be disabled after August 20, 2025.¹⁶¹⁷

What G7 Users Can Do Now

If you use a Dexcom G7 and want to protect yourself while the litigation plays out:

Confirm your smartphone app is updated to a version released after the July 2025 recall, and test your handheld receiver’s speaker regularly during charging, as Dexcom advised. Free replacement receivers are available for affected units.¹⁵
Keep records of any sensor failures, missed alerts, or inaccurate readings, along with purchase dates, serial numbers, and any related medical events. These are the facts that determine whether you have an individual claim or fit within the consumer class.
If a serious injury or death occurred, an individual product liability suit like the Tennessee wrongful death case is a separate track from the class action and may need to be filed within your state’s statute of limitations. Consulting a product liability attorney about your specific timeline is the appropriate next step.
If you are already a class member candidate under Grisoli/Levens, watch for a class notice once (and if) certification is granted. You do not need to act now to preserve class rights, though contacting Wisner Baum or the other firms involved is an option.

Every case discussed here is in an early procedural posture. No class has been certified, no settlements have been announced, and Dexcom has not yet formally answered the consumer complaints.⁷¹³

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U.S. Food and Drug Administration. Dexcom Inc Warning Letter
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MedTech Dive. Dexcom G7 Class Action Lawsuit
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U.S. Food and Drug Administration. Dexcom G7 App Recall
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