Has Masimo Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Masimo Corporation: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695

Name: FDA Recall Record — Masimo Corporation
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:20Z
Source ID: Z-2670-2026
Payload hash: ffab793a1134ad6b104c33a4…

Summary

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small… Status: Ongoing.

Entities

Masimo Corporation

View source record ↗

Frequently asked questions

Has Masimo Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 2 total FDA actions tied to Masimo Corporation: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-masimo-corporation-z-2670-2026

MLA

"Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-masimo-corporation-z-2670-2026.

Chicago

Argus HQ Research. "Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-masimo-corporation-z-2670-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_masimo_corporation_z_2670_2026_2026,
  title = {Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-masimo-corporation-z-2670-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.