Use cautionMedical device recall · FDA · Published June 14, 2019
Terumo Capiox NX1: Non-functioning thermistor in oxygenator risks malfunction
Terumo recalls oxygenator model 3CX*NX19RE with possible non-functioning thermistor that could cause oxygen delivery issues. Affected units sold in 2017 with lot number WP17.
“Terumo Capiox NX1: Non-functioning thermistor in oxygenator risks malfunction.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67665-terumo-capiox-nx1-non-functioning-thermistor-in-oxygenator-risks-malfunction. Based on FDA recall #Z-2101-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2101-2019%22&limit=1).
Terumo Cardiovascular Systems Corporation voluntarily recalled 16 units of the Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE, Lot Number: WP19, due to a potential non-functioning arterial thermistor component, according to the FDA on June 14, 2019.
How to tell if you have it
Brand: Terumo
Product: Capiox NX19 Oxygenator With Reservoir (East Orientation)
Part Number: 3CX*NX19RE
Lot Number: WP17
Units affected: 16
The hazard
The recalled Capiox NX19 Oxygenator With Reservoir may contain a non-functioning arterial thermistor component, according to the FDA.
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 NOxBOXi Nitric Oxide Delivery System (September 14, 2026), NOXBOX Nitric Oxide Delivery System (August 19, 2026), and Hillrom Volara System Circuit Kit (May 21, 2026).
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
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
MI Foreign: Japan, Belgium
Recall number
Product, codes & lots
Quantity
Z-2101-2019
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE; Lot Number: WP17
16 units
Z-2102-2019
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW; Lot Numbers: XAl 1, XA28, XC07
52units
Z-2103-2019
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market; Lot Numbers: XA28, XC12, XC25, XD05, XD27
78 units
Z-2104-2019
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market; Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27
123 units
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.
Where it went and when
Where it was distributed
Distributed in Michigan, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “MI Foreign: Japan, Belgium” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Michigan.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.