Terumo Capiox NX1: Oxygenator with non-functioning thermistor hazard

Take action

Contact the company & request your remedy

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 incorrect blood temperature monitoring during medical use.

Why it’s dangerous

The oxygenator may have a thermistor that doesn't work properly. This could cause the device to fail in monitoring blood temperature during medical procedures. Inaccurate temperature readings might lead to complications for patients.

Who’s affected

Medical professionals using the Terumo Capiox NX19 Oxygenator with reservoir (West Orientation) model P/N 3CX*NX19RW are most at risk. Patients receiving this device could experience inaccurate blood temperature readings.

How to tell if you have this one

Check for the model number 3CX*NX19RW on the oxygenator. Lot numbers XAl 1, XA28, or XC07 indicate affected units. The device has a West Orientation reservoir.

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*NX19RW on the oxygenator.
Contact Manufacturer
Reach out to Terumo Cardiovascular Systems Corporation for further assistance.

✎ GovInfoNow

Questions people ask

Is this oxygenator dangerous?

The oxygenator may have a non-functioning thermistor component, which could lead to inaccurate blood temperature monitoring during medical use.

What should I do if I have this oxygenator?

Check the model number and lot numbers to see if your device is affected. Contact Terumo for further instructions.

How can I tell if my oxygenator is affected?

Affected units have model number 3CX*NX19RW and lot numbers XAl 1, XA28, or XC07 with West Orientation reservoir.

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-2102-2019 — Terumo Terumo

Hello,

I own a Terumo that is covered by recall Z-2102-2019 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2102-2019 (June 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2102-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 (West Orientation) P/N: 3CX*NX19RW

Lower-risk recall