Lower risk Medical device recall · FDA · Published March 3, 2025

Terumo CDI OneView Hematocrit Probe: Dashed SO2 Values May Trigger False Alarms

Terumo recalls hematocrit/oxygen probes with specific serial numbers due to occasional dashed SO2 values causing false low-limit alarms. Affected units may need verification.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1492-2025Medical device Terumo ›

Lower-risk 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.

Take action

Contact the company

Recalling firmTerumo Cardiovascular Systems Corporation6200 Jackson Rd · Ann Arbor, MI 48103-9586

✎ GovInfoNow plain-language explainer

Terumo is recalling hematocrit and oxygen saturation probes that sometimes show dashed values on the screen, which can trigger false low-limit alarms. This could lead to incorrect patient monitoring readings if not addressed. Read more at govinfonow.com/recall/52704-terumo-cdi-oneview-hematocrit-probe-dashed-so2-values-may-trigger.

Source Summary by GovInfoNow · govinfonow.com/recall/52704-terumo-cdi-oneview-hematocrit-probe-dashed-so2-values-may-trigger · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1492-2025

Cite this page

“Terumo CDI OneView Hematocrit Probe: Dashed SO2 Values May Trigger False Alarms.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52704-terumo-cdi-oneview-hematocrit-probe-dashed-so2-values-may-trigger. Based on FDA recall #Z-1492-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2025%22&limit=1).

The FDA announced on March 3, 2025, that Terumo Cardiovascular Systems Corporation is recalling its CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe due to a hazard involving unavailable data displays. The agency issued recall number Z-1492-2025 for the voluntary Class II action.

How to tell if you have it

Brand: Terumo
Product: CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe
Catalog Number: REF CD1754
UDI/DI: 00886799001882
Serial Numbers: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Units affected: 37
Sold in: IL, TX, NY, MI, FL, NV, and Australia, New Zealand

The hazard

According to the FDA, during some clinical cases, the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these instances, a yellow low-limit alarm is triggered to the user due to the dashed-out value.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include a May 28, 2025 recall for temperature inaccuracy risk and a February 20, 2024 recall for high crack check valve risk of myocardial damage. A September 14, 2026 recall was issued for the NOxBOXi Nitric Oxide Delivery System regarding potential for irregular oxygen readings.

How to tell if you have this one

Check the serial number on the probe, which falls within the ranges H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, or H0050140-H0050142.

Brand
Terumo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify the probe's serial number against the listed ranges to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 6 states, and outside the U.S.

FDA distribution: “US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Illinois, Michigan, Nevada, New York, Texas.

Recall timeline

FDA published this recall 37 days after the firm started it.

Mar 3, 2025Firm started the recall
Mar 31, 2025FDA classified it Class II
Apr 9, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52704-terumo-cdi-oneview-hematocrit-probe-dashed-so2-values-may-trigger">Terumo CDI OneView Hematocrit Probe: Dashed SO2 Values May Trigger False Alarms (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1492-2025 (March 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1492-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.