Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor)
Medical device recall Z-1536-2024. Published in FDA’s Enforcement Report on Apr 24, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 24, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 45 states named
- 443 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
443 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 6000084005 6000084009 6000084010 6000084012 6000084013 6000084015 6000084016 6000084038 6000084046 6000084052 6000084057…
Every code shown here, 1,998 characters
UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 6000084005 6000084009 6000084010 6000084012 6000084013 6000084015 6000084016 6000084038 6000084046 6000084052 6000084057 6000084059 6000084060 6000084064 6000084067 6000084071 6000084080 6000084134 6000084140 6000084165 6000084175 6000084184 6000084192 6000084196 6000084197 6000084200 6000084201 6000084202 6000084207 6000084266 6000084278 6000084279 6000084280 6000084282 6000084284 6000084285 6000084286 6000084287 6000084288 6000084289 6000084296 6000084299 6000084306 6000084310 6000084313 6000084314 6000084315 6000084317 6000084318 6000084319 6000084321 6000084325 6000084326 6000084328 6000084329 6000084331 6000084332 6000084398 6000084410 6000084418 6000084424 6000084478 6000084481 6000084512 6000084546 6000084553 6000084554 6000084556 6000084562 6000084565 6000084566 6000084580 6000084583 6000084590 6000084591 6000084592 6000084593 6000084594 6000084596 6000084598 6000084600 6000084602 6000084604 6000084609 6000084610 6000084615 6000084618 6000084620 6000084624 6000084625 6000084627 6000084629 6000084633 6000084634 6000084635 6000084636 6000084637 6000084638 6000084640 6000083850 6000083851 6000083852 6000083853 6000083857 6000083858 6000083859 6000083860 6000083861 6000083863 6000083866 6000083867 6000083868 6000083869 6000083871 6000083872 6000083873 6000083874 6000083876 6000083879 6000083888 6000083891 6000083893 6000083895 6000083896 6000083903 6000083904 6000083905 6000083907 6000083908 6000083913 6000083914 6000083915 6000083916 6000083918 6000083919 6000083920 6000083923 6000083924 6000083925 6000083929 6000083930 6000083934 6000083943 6000083944 6000083948 6000083950 6000083956 6000083960 6000083962 6000083965 6000083966 6000083967 6000083970 6000083972 6000083977 6000083979 6000083980 6000083982 6000083984 6000083986 6000083995 6000083998 6000084001 6000084006 6000084007 6000084017 6000084021 6000084024 6000084025 6000084031 6000084032…
FDA’s list runs to 4,912 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia, Congo, The Democratic Republic of, Costa Rica, Cyprus, Czech Republic, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Lesotho, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Poland, Puerto Rico, Qatar, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tanzania, United Republic Of, Thailand, Trinidad And Tobago, Uganda, United Kingdom, Uruguay, Yemen, Zimbabwe.
The states and territories these words name
45 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 15, 2024.
- FDA classified it on Apr 12, 2024.
- FDA’s Enforcement Report published it on Apr 24, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Masimo Corporation, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,912 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.