Terumo Capiox NX1: Non-functioning thermistor in oxygenator risks malfunction

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Recalling firmTerumo Cardiovascular Systems Corporation125 Blue Ball Rd, N/A · Elkton, MD 21921-5315

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Terumo is recalling a specific oxygenator model that may have a faulty thermistor component. This could lead to improper oxygen delivery during medical use, potentially causing harm to patients.

Why it’s dangerous

The oxygenator may have a thermistor that doesn't work properly. This could cause the device to deliver incorrect oxygen levels to patients, potentially leading to health complications.

Who’s affected

Patients using this oxygenator for medical treatment are most at risk. The recall applies to specific units sold with lot number WP17 in 2017.

How to tell if you have this one

Check for the model number 3CX*NX19RE on the oxygenator. Units sold with lot number WP17 in 2017 are affected.

Brand
Terumo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number 3CX*NX19RE on the oxygenator.
Contact Manufacturer
Contact Terumo Cardiovascular Systems Corporation for specific guidance on next steps.

✎ GovInfoNow

Questions people ask

Is this oxygenator dangerous?

The oxygenator may have a non-functioning thermistor that could cause improper oxygen delivery, but the risk level is not severe enough to require immediate stop use.

How do I know if my oxygenator is affected?

Check for model number 3CX*NX19RE and lot number WP17 from the 2017 sale date.

What should I do if I have this oxygenator?

Contact Terumo Cardiovascular Systems Corporation for specific guidance on next steps.

Take action

Contact Terumo

We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2101-2019 — Terumo Terumo

Hello,

I own a Terumo that is covered by recall Z-2101-2019 from Terumo.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-2101-2019 (June 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2101-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE

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