_Incident · Regulatory action_

# FDA warning letter to Whoop: Blood Pressure Insights marketed beyond clearance

Canonical ID: `2551f142-584e-48a5-978d-ff8c82023c01`

- **Occurred:** 2025-07-14
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Model:** [Whoop (5.0 / MG)](/models/whoop-mg.md) (id: `82591feb-716d-4033-ae7e-611f253022cd`)

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.

## Sources (2)

1. **FDA** · https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025
2. **MobiHealthNews** · https://www.mobihealthnews.com/news/whoop-receives-warning-letter-fda-blood-pressure-insights

## Common questions

### 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) is the recorded robot involved in this incident.

### 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.


_API: GET /v1/incidents/2551f142-584e-48a5-978d-ff8c82023c01 · sources: /v1/incidents/2551f142-584e-48a5-978d-ff8c82023c01/sources · responses: /v1/incidents/2551f142-584e-48a5-978d-ff8c82023c01/responses · status: /v1/incidents/2551f142-584e-48a5-978d-ff8c82023c01/status · canonical URL: /incidents/whoop-bpi-fda-warning-letter-2025_