Whoop Under Fire for “Medical-Grade” Tracker Claims Flagged by FDA

Case Overview: The lawsuit says Whoop falsely sold “medical-grade” trackers without FDA approval.

Consumers Affected: Whoop MG device buyers who paid for premium health features.

Court: U.S. District Court for the Northern District of California

Fitness technology company Whoop is facing legal heat from consumers who are accusing the company of marketing its top-tier fitness tracker as a medical-grade device despite lacking the federal approvals needed to back those claims. 

A new proposed class action lawsuit argues the company sold its Whoop MG device and accompanying Life Membership by promising daily blood-pressure insights that regulators later determined it is not authorized to provide.

The case centers on Whoop’s Blood Pressure Insights feature, a premium tool exclusive to the Life tier that the company promotes as offering daily systolic and diastolic ranges, complete with color-coded readings and wellness interpretations. 

According to the lawsuit, consumers who paid extra for these capabilities were led to believe they were purchasing advanced, clinically reliable data, however the FDA has stated the device is both misbranded and not cleared to estimate blood pressure at all.

Buyers Say They Paid Extra for Features the FDA Says Aren’t Legal

California resident Wendell Rowe filed the lawsuit after he bought the Whoop Life Membership after researching the company’s three membership tiers and deciding that the MG device’s advertised medical-grade features justified the higher cost. 

Rowe says packaging and online descriptions emphasized capabilities such as heart screening, ECG readings, and daily blood-pressure metrics, elements he said set the Life tier apart from Whoop’s cheaper options.

His complaint argues that there was no way he would have paid the premium price had he known the MG device lacked FDA authorization and could not legally deliver the medical-grade data that drove his decision. 

Regulators Deem Whoop’s Blood-Pressure Tool Misbranded

Whoop markets three annual membership options—One, Peak, and Life—each paired with a different device and pitched to different types of users, the lawsuit explains. The Life tier is promoted as offering the most advanced health monitoring, including daily blood-pressure ranges calculated from overnight biometric data. 

The lawsuit claims these representations made consumers think the device could provide true clinical information, especially when combined with packaging that presents the MG device as a medical-grade heart monitor.

But federal regulators disagreed. In a warning letter issued in July 2025, the FDA said Whoop’s blood-pressure feature functions as a medical device and requires clearance before being sold, something the company had not done. 

Because the company did not seek approval, regulators deemed the product adulterated, misbranded, and not legally saleable.

FDA Steps Up Oversight of Misleading Health-Tech Marketing

Whoop’s case is one of several lawsuits that stem from the FDA targeting companies accused of overstating health or diagnostic capabilities. 

OPTASE® Dry Eye Intense Drops was sued by consumers after they found out it hadn’t secured approval from federal regulators putting consumers at risk.

EzriCare LLC has faced multiple class action lawsuits after the FDA found its artificial tears were contaminated with bacteria, leading to reports of severe infections, blindness, and even death.

Meanwhile, California medical device company Dexcom is under fire from consumers who claim its G6 and G7 glucose monitors give dangerously inaccurate blood sugar readings. The lawsuit came after the FDA found the company had made changes to the devices without regulatory approval and caused the devices to produce false readings that could endanger users who depend on them for daily care. 

And Glenmark is facing legal action after recalling millions of capsules of its extended-release potassium chloride medication. The recall was made after the FDA issued its most serious level recall for the product.

In the Whoop health tracker class action lawsuit, Rowe wants to represent California residents who purchased the Whoop MG device within the past four years. He alleges the company violated state consumer protection laws and profited from misleading marketing. 

Rowe is seeking damages for buyers, court-ordered changes to Whoop’s practices, and reimbursement of legal fees and related costs.

Case Details

• Lawsuit: Rowe v. Whoop, Inc.
• Case Number: 3:25-cv-09910
• Court: U.S. District Court for the Northern District of California

Plaintiffs' Attorney:

• Frederick J. Klorczyk Iii (Kamberlaw, LLC) 
• Kevin Laukaitis (Laukaitis Law LLC)

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