Class II — Masimo Corporation
| Recalling firm | MASIMO CORPORATION |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. |
| Product | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, |
| Quantity | 443 units |
| Distribution | 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, C… |
| Initiated | 2024-02-15 |
| Classified | 2024-04-12 |
| Recall number | Z-1536-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Masimo Corporation (Z-1536-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94170/
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