How many FDA warning letters has Masimo Corporation received?

Argus HQ has not recorded an FDA warning letter for Masimo Corporation in our current dataset.

What FDA recalls has Masimo Corporation issued?

Argus HQ has recorded 2 FDA recalls tied to Masimo Corporation.

Is Masimo Corporation FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for Masimo Corporation. Review the linked FDA source records directly before drawing a compliance conclusion.

.hq

company

Masimo Corporation

Name: FDA Enforcement Actions Against Masimo Corporation
Creator: Argus HQ
License: https://argushq.ai/methodology

Industry: Medical Devices

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-07-08
Masimo Corporation — Class II recall: Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
fda_recall · device_recall2026-07-08
Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695

Frequently asked questions

How many FDA warning letters has Masimo Corporation received?: Argus HQ has not recorded an FDA warning letter for Masimo Corporation in our current dataset.
What FDA recalls has Masimo Corporation issued?: Argus HQ has recorded 2 FDA recalls tied to Masimo Corporation.
Is Masimo Corporation FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 2 recalls, and 0 approval records for Masimo Corporation. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.