PlainRecalls

Masimo Corporation

Compiled from official public sources by the publisher.

13 recalls on record · Latest: Jul 8, 2026

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Agency notice ledger

Federal filing book Masimo Corporation LIGHT-BOOK · SINGLE-AGENCY

#1,186 of 14,151 · 13 notices · 0.012% archive

  • BOOK 13 notices
  • RANK #1,186 of 14,151
  • SHARE 0.012% archive
  • AGENCY FDA Devices (13)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 8, 2026
  • PHOTO Aequita Pharmacy

Nearest notice-volume peer: Aequita Pharmacy (0 notice gap)

Masimo Corporation accounts for about 0.012% of the 104,423-notice archive on 13 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Masimo Corporation's standing among 14,151 recalling firms

Masimo Corporation ranks 1,186th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Masimo Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

13 1186th of 14151 higher than 12,927 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Masimo Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Masimo Corporation holds about 0.012% of archive notices alongside 13 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 8, 2026

Radius VSM ECG pre-connected Set, REF: 4842, 4695
FDA Devices Moderate Jul 8, 2026

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
FDA Devices Moderate Apr 24, 2024

Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
FDA Devices Moderate Apr 24, 2024

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
FDA Devices Moderate Apr 24, 2024

Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
FDA Devices Moderate Apr 24, 2024

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
FDA Devices Moderate Jun 28, 2023

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
FDA Devices Moderate Jun 28, 2023

Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
FDA Devices Moderate Jun 28, 2023

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
FDA Devices Moderate Jun 28, 2023

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
FDA Devices Moderate Dec 2, 2015

rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
FDA Devices Moderate Nov 19, 2014

Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
FDA Devices Moderate May 8, 2013

Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

Masimo Corporation holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (13 here — thin-book).

Aequita Pharmacy 13 Alden Optical 13 Amneal Pharmaceuticals, LLC 13 Ani Pharmaceuticals, Inc. 13 AtriCure, Inc. 13

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aequita Pharmacy 13 Alden Optical 13 AtriCure, Inc. 13 Augustine Temperature Management, LLC 13

Frequently Asked Questions

How many federal recall notices name Masimo Corporation? ▼
PlainRecalls indexes 13 distinct federal recall events naming Masimo Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Masimo Corporation sit among other recalling firms? ▼
Masimo Corporation ranks #1,186 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Masimo Corporation's notices? ▼
FDA Devices accounts for 13 of this firm's 13 indexed notices.
What product category dominates Masimo Corporation's filing book? ▼
Filings for Masimo Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Masimo Corporation: 13 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Masimo Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026