Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe Recalled by Terumo Cardiovascular Systems Corporation Due to During some clinical cases, it has been observed...

Date: March 3, 2025
Company: Terumo Cardiovascular Systems Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.

Affected Products

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Quantity: 37 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 6 states: FL, IL, MI, NV, NY, TX

Affected (6 states)Not affected

About Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report