Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation… — Class II medical device recall Z-1492-2025
Ongoing recall by Terumo Cardiovascular Systems Corporation, reported 2025-04-09, distributed in FL, IL, MI, NV, NY, TX. During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the T
| Recall number | Z-1492-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2025-03-03 |
| Classified | 2025-03-31 |
| Reported by FDA | 2025-04-09 |
| Distributed | FL, IL, MI, NV, NY, TX |
| Countries outside the US | AU, NZ |
| Quantity | 37 units |
| UPC / GTIN / UDI-DI | 00886799001882 |
| Model numbers | CD1754 |
Product
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Reason for recall
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
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-1492-2025. 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.