Lower risk Medical device recall · FDA · Published May 28, 2025

Terumo CDI OneView BPM Probe Recall: Temperature Inaccuracy Risk

Terumo recalls CDI OneView BPM Probes with potential temperature measurement errors that could lead to incorrect patient vital signs. Affected units have specific serial numbers and model numbers. Consumers should contact Terumo for details.

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

🇺🇸 FDA recall #Z-2018-2025Medical device Terumo ›

Lower-risk recall

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Terumo is recalling CDI OneView BPM Probes that may show inaccurate temperature readings. This could lead to incorrect patient vital signs if not addressed. The recall affects specific model numbers and serial ranges. Read more at govinfonow.com/recall/52195-terumo-cdi-oneview-bpm-probe-recall-temperature-inaccuracy-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52195-terumo-cdi-oneview-bpm-probe-recall-temperature-inaccuracy-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2018-2025

Cite this page

“Terumo CDI OneView BPM Probe Recall: Temperature Inaccuracy Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52195-terumo-cdi-oneview-bpm-probe-recall-temperature-inaccuracy-risk. Based on FDA recall #Z-2018-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2018-2025%22&limit=1).

The FDA announced on May 28, 2025, that Terumo Cardiovascular Systems Corporation is recalling CDI OneView System BPM Probes due to potential temperature measurement inaccuracies. The agency issued recall number Z-2018-2025 for the voluntary Class II action.

How to tell if you have it

Brand: Terumo
Product: CDI OneView BPM Probe (Cat. No. CDI753)
Product: CDI OneView BPM Probe Trial Kit (Cat. No. CDI753TK)
Lot Numbers: B0050231-B0050240, B0050221-B0050230, B0050211-B0050219, B0050201-B0050209, B0050191-B0050200
Distribution: California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, Washington, and New Zealand

The hazard

According to the FDA, an assembly error in the thermistor may cause inaccurate shunt sensor temperature readings. This inaccuracy can affect other measured parameters including pCO2, pO2, pH, Potassium, and calculated values like Bicarbonate and Arterial Oxygen Saturation. Inaccurate data may lead to inappropriate user response.

Context

GovInfoNow's records show Terumo Cardiovascular Systems Corporation has had 20 other recalls on record since June 27, 2017. Other recent recalls of similar products include Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (May 28, 2026), and Medline Namic Preceptor Manifold Recall (March 24, 2026).

How to tell if you have this one

Check for model numbers CDI753 or CDI753TK and serial numbers in the ranges B0050201-B0050240. The recall covers specific batches with UDI-DI 00886799001889.

Brand
Terumo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Terumo
Reach out to Terumo for specific guidance on the affected units and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

FDA distribution: “US Nationwide distribution in the states of California, Delaware, Hawaii, Iowa, Indiana, Michigan, North Carolina, New York, Ohio, and Washington. The country of New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Delaware, Hawaii, Indiana, Iowa, Michigan, New York, North Carolina, Ohio, Washington.

Recall timeline

FDA published this recall 35 days after the firm started it.

May 28, 2025Firm started the recall
Jun 24, 2025FDA classified it Class II
Jul 2, 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/52195-terumo-cdi-oneview-bpm-probe-recall-temperature-inaccuracy-risk">Terumo CDI OneView BPM Probe Recall: Temperature Inaccuracy Risk (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-2018-2025 (May 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2018-2025 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.