# FDA recall Z-1492-2025

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2025-03-03.

## 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.

## Distribution

US:  IL, TX, NY, MI, FL, NV, and Australia, New Zealand

## Key facts

- **Recall number:** Z-1492-2025
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2025

## Citation

> AI Analytics. FDA recall Z-1492-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1492-2025. Source: US FDA. Licensed CC0.

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