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Masimo Corporation

Complete recall history across all FDA and CPSC categories — 11 total recalls

Masimo Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (11)

FDA medical device enforcement actions by Masimo Corporation

Date Product Reason Class
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, Their is a potential that Oximeter may automatically power off and on result... Class II
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, Their is a potential that Oximeter may automatically power off and on result... Class II
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, Their is a potential that Oximeter may automatically power off and on result... Class II
Feb 15, 2024 Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, Their is a potential that Oximeter may automatically power off and on result... Class II
Apr 21, 2023 Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II
Apr 21, 2023 Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II
Oct 28, 2015 rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; ... These sensors were manufactured with incompatible configurations. This could ... Class II
Sep 30, 2014 Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-li... Firm has identified a small number of Oximetry Cables with crossed-internal w... Class II
Mar 13, 2013 Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories... Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pi... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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