Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Why it was recalled
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
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.
Recall record
- Recalling firm
- Masimo Corporation
- Product type
- Devices
- Recall number
- Z-1539-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Irvine, CA
- Recall initiated
- 2024-02-15
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1539-2024 · Source: openFDA enforcement.