Recall archive / FDA device enforcement
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 — FDA record Z-1492-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 37 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1492-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Mar 3, 2025
- Center classification date
- Mar 31, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.