CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report

Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo

Masimo is recalling Masimo Rad-G, Pulse Oximeter (W/Patient Cable), distributed nationwide in the US. The recall was initiated on 15 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:(01)00843997013789/ Serial Numbers: 6000083849 6000083870 6000083875 6000083898 6000083909 6000083932 6000083941 6000083959 6000083974 6000083978 6000083983 6000083991 6000083997 6000083999 6000084011 6000084018 6000084020 6000084042 6000084055 6000084075 6000084084 6000084090 6000084101 6000084106 6000084112 6000084132 6000084133 6000084157 6000084163 6000084181 6000084205 6000084211 6000084222 6000084236 6000084276 6000084290 6000084364 6000084392 6000084394 6000084429 6000084439 6000084442 6000084454 6000084455 6000084457 6000084513 6000084536 6000084543 6000084567 6000084574 6000084575 6000084607 6000084613 6000084647 6000090319 6000090325 6000090331 6000090333 6000090339 6000084465 6000083931 6000083954 6000083963 6000084250 6000084309

Quantity recalled65

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1539-2024
FDA event ID: 94170
Recalling firm: Masimo, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 15 Feb 2024
FDA classified: 12 Apr 2024
Reported: 24 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

15 Feb 2024	Recall initiated by company
12 Apr 2024	Classified by FDA	+57 days
24 Apr 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Product as listed by the FDA

Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan

Questions about this recall

Is Rad-G, Pulse Oximeter (W/Patient Cable) recalled?

Yes. Masimo recalled Rad-G, Pulse Oximeter (W/Patient Cable) on 15 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1539-2024.

Why was it recalled?

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

Which lots are affected?

UDI:(01)00843997013789/ Serial Numbers: 6000083849 6000083870 6000083875 6000083898 6000083909 6000083932 6000083941 6000083959 6000083974 6000083978 6000083983 6000083991 6000083997 6000083999 6000084011 6000084018 6000084020 6000084042 6000084055 6000084075 6000084084 6000084090 6000084101 6000084106 6000084112 6000084132 6000084133 6000084157 6000084163 6000084181 6000084205 6000084211 6000084222 6000084236 6000084276 6000084290 6000084364 6000084392 6000084394 6000084429 6000084439 6000084442 6000084454 6000084455 6000084457 6000084513 6000084536 6000084543 6000084567 6000084574 6000084575 6000084607 6000084613 6000084647 6000090319 6000090325 6000090331 6000090333 6000090339 6000084465 6000083931 6000083954 6000083963 6000084250 6000084309

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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24 Apr 2024Device	CLASS II	Rad-G, Pulse Oximeter (W/Patient Cable) recalled by Masimo	Masimo	Other	Nationwide
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