Masimo Rad-G, Pulse Oximeter (W/Sensor)
Medical device recall Z-1537-2024. 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
- 21,723 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/Sensor), REF:9847, Rx Only,
21,723 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI:(01)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 6000062126 6000062127 6000062128 6000062129 6000062130 6000062131 6000062132 6000062133 6000062134 6000062135 6000062136…
Every code shown here, 1,998 characters
UDI:(01)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 6000062126 6000062127 6000062128 6000062129 6000062130 6000062131 6000062132 6000062133 6000062134 6000062135 6000062136 6000062137 6000062138 6000062139 6000062140 6000062141 6000062142 6000062143 6000062144 6000062145 6000062146 6000062147 6000062148 6000062149 6000062150 6000062151 6000062152 6000062153 6000062154 6000062155 6000062156 6000062157 6000062158 6000062159 6000062160 6000062161 6000062162 6000062163 6000062164 6000062165 6000062166 6000062167 6000062168 6000062169 6000062170 6000062171 6000062172 6000062173 6000062174 6000062175 6000062176 6000062177 6000062178 6000062179 6000062180 6000062181 6000062182 6000062183 6000062184 6000062185 6000062186 6000062187 6000062188 6000062189 6000062190 6000062191 6000062192 6000062194 6000062195 6000062196 6000062197 6000062198 6000062199 6000062200 6000062201 6000062202 6000062203 6000062204 6000062205 6000062206 6000062207 6000062208 6000062209 6000062210 6000062211 6000062212 6000062213 6000062214 6000062215 6000062216 6000062217 6000062218 6000062219 6000062220 6000062221 6000062222 6000062223 6000062224 6000062225 6000062226 6000062227 6000062228 6000062229 6000062230 6000062231 6000062232 6000062233 6000062234 6000062235 6000062236 6000062237 6000062238 6000062239 6000062240 6000062241 6000062242 6000062243 6000062244 6000062245 6000062246 6000062247 6000062248 6000062249 6000062250 6000062251 6000062252 6000062253 6000062254 6000062255 6000062256 6000062257 6000062258 6000062259 6000062260 6000062261 6000062262 6000062263 6000062264 6000062265 6000062266 6000062267 6000062268 6000062269 6000062270 6000062271 6000062272 6000062273 6000062274 6000062275 6000062276 6000062277 6000062278 6000062279 6000062280 6000062281 6000062282 6000062283 6000062284 6000062285 6000062286 6000062287 6000062288 6000062289 6000062291 6000062292 6000062293 6000062294 6000062295 6000062296 6000062297 6000062298…
FDA’s list runs to 239,017 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 239,017 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.