Masimo Rad-G, Pulse Oximeter (W/Patient Cable)
Medical device recall Z-1538-2024. 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
- 4978 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 (W/Patient Cable), REF:9849, Rx Only,
4978 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000066282 6000066408 6000066411 6000066442 6000066476 6000066577 6000066623 6000066856 6000067119 6000067120 6000067122…
Every code shown here, 1,996 characters
UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000066282 6000066408 6000066411 6000066442 6000066476 6000066577 6000066623 6000066856 6000067119 6000067120 6000067122 6000067134 6000067140 6000067142 6000067145 6000067150 6000067151 6000067162 6000067163 6000067167 6000067168 6000067170 6000067173 6000067175 6000067176 6000067177 6000067178 6000067179 6000067180 6000067182 6000067183 6000067185 6000067186 6000067188 6000067192 6000067193 6000067194 6000067196 6000067198 6000067201 6000067202 6000067207 6000067211 6000067224 6000067225 6000067235 6000067241 6000067245 6000067246 6000067247 6000067252 6000067256 6000067269 6000067272 6000067278 6000067293 6000067300 6000067309 6000067311 6000067312 6000067314 6000067345 6000067356 6000067357 6000067360 6000067366 6000067367 6000067418 6000067443 6000067446 6000067472 6000067475 6000067482 6000067484 6000067486 6000067496 6000067515 6000067552 6000067563 6000067584 6000067609 6000067625 6000067626 6000067629 6000067642 6000067658 6000067660 6000067662 6000067663 6000067673 6000067679 6000067680 6000067686 6000067689 6000067695 6000067701 6000067702 6000067710 6000067711 6000067718 6000067721 6000067729 6000067730 6000067732 6000067736 6000067751 6000067752 6000067757 6000067760 6000067764 6000067780 6000067783 6000067790 6000067807 6000067824 6000067832 6000067833 6000067838 6000067839 6000067849 6000067853 6000067864 6000067902 6000067906 6000067921 6000067922 6000067925 6000067926 6000067944 6000067959 6000067963 6000067993 6000068018 6000068042 6000068074 6000068120 6000068140 6000068226 6000068259 6000068262 6000068273 6000068274 6000068295 6000068301 6000068307 6000068311 6000068325 6000068327 6000068332 6000068333 6000068385 6000068386 6000068390 6000068391 6000068404 6000068406 6000068422 6000068437 6000068438 6000068440 6000068451 6000068452 6000068477 6000068489 6000068493 6000068494 6000068498 6000068503 6000068516 6000068522 6000068524…
FDA’s list runs to 54,796 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 54,796 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.