FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance
[REGULATORY ACTION]Jul 14, 2025 · Whoop · Whoop (5.0 / MG) · Global
Failure Mode
REGULATORY ACTION
Event Date
Jul 14, 2025
Primary Entity
Whoop
Robotic Platform
Whoop (5.0 / MG)
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
On July 14 2025 the FDA issued Whoop a warning letter (MARCS-CMS 709755) stating that the Blood Pressure Insights (BPI) daily systolic/diastolic estimation feature on the WHOOP MG / Life membership is an unapproved medical device marketed without clearance, since BP estimation is inherently tied to diagnosis of hypo-/hypertension. Whoop publicly disagreed (Jul 15 2025) and BPI remained accessible; as of mid-2026 the dispute is UNRESOLVED with no recall. The load-bearing marketing-beyond-clearance exemplar of the biometric cohort.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025
- Inspect Filing
https://www.mobihealthnews.com/news/whoop-receives-warning-letter-fda-blood-pressure-insights
https://www.mobihealthnews.com/news/whoop-receives-warning-letter-fda-blood-pressure-insights
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Details
Incident Context & FAQ
What happened in FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance?
On July 14 2025 the FDA issued Whoop a warning letter (MARCS-CMS 709755) stating that the Blood Pressure Insights (BPI) daily systolic/diastolic estimation feature on the WHOOP MG / Life membership is an unapproved medical device marketed without clearance, since BP estimation is inherently tied to diagnosis of hypo-/hypertension. Whoop publicly disagreed (Jul 15 2025) and BPI remained accessible; as of mid-2026 the dispute is UNRESOLVED with no recall. The load-bearing marketing-beyond-clearance exemplar of the biometric cohort.
When did this incident occur?
The incident is recorded as occurring on July 14, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance?
Whoop (5.0 / MG) by Whoop is the recorded robot involved in this incident at Global.
Has anyone responded to FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.