Masimo Rad-G — Class II medical device recall Z-1538-2024
Ongoing recall by Masimo Corporation, reported 2024-04-24, distributed nationwide. Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
| Recall number | Z-1538-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2024-02-15 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BH, BO, BZ, CA, CH, CL, CO, CR, CY, CZ, DE, DZ, ES, FI, FR, GB, GR, GT, HK, ID, IL, IN, IT, JP, NG, NL, NO, NZ, OM, PA, PK, PL, QA, SA, SE, SG, SI, SK, TH, TT, UY |
| Quantity | 4,978 units |
| UPC / GTIN / UDI-DI | 00843997000666 |
| Serial numbers | 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 and 475 more |
| Model numbers | 9849 |
Product
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Reason for recall
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1538-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.