Use cautionMedical device recall · FDA · Published March 1, 2023
Terumo CAPIOX NX19 Oxygenator Recall: Possible Leak Risk
Terumo recalls CAPIOX NX19 Hollow Fiber Oxygenators with specific catalog numbers due to potential leak at arterial thermistor connection. Affected units may need repair or replacement.
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
Take action
Contact the company
📍Recalling firmTerumo Cardiovascular Systems Corporation125 Blue Ball Rd · Elkton, MD 21921-5315
“Terumo CAPIOX NX19 Oxygenator Recall: Possible Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58799-terumo-capiox-nx19-oxygenator-recall-possible-leak-risk. Based on FDA recall #Z-1346-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1346-2023%22&limit=1).
The FDA announced on March 1, 2023, that Terumo Cardiovascular Systems Corporation is voluntarily recalling the CAPIOX NX19 Hollow Fiber Oxygenator. The agency stated the recall addresses a potential leak at the arterial thermistor bonding point.
How to tell if you have it
Brand: Terumo
Product: CAPIOX NX19 Hollow Fiber Oxygenator
Catalog Number: 3CX*NX19RE
UPC: 00699753450868
Lot Number: AM03
Quantity: 84 units
The hazard
Some units may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This defect may result in a leak at the point where the arterial thermistor is bonded to the oxygenator port.
Context
GovInfoNow's records show Terumo Cardiovascular Systems Corporation has 20 other recalls on record since June 27, 2017. Recent brand recalls include a May 28, 2025 recall for the Terumo CDI OneView BPM Probe due to temperature inaccuracy risk and a March 3, 2025 recall for the Terumo CDI OneView Hematocrit Probe regarding dashed SO2 values. Other recent recalls of similar products include the NOXBOX Nitric Oxide Delivery System Recall (August 19, 2026) and the Hillrom VOLARA System Circuit Kit Recall (May 21, 2026).
How to tell if you have this one
Check for the catalog number 3CX*NX19RE on the oxygenator. The UDI-DI code (01)00699753450868 and lot number AM03 are also associated with this recall.
Brand
Terumo
Product
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Category
Medical device
FDA recall event · 3 products
All 3 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
Ongoing
Distribution
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Recall number
Product, codes & lots
Quantity
Z-1345-2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30; UDI-DI: (01)00699753450134; Lot Number: 2M10
1412 units
Z-1346-2023
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE; UDI-DI: (01)00699753450868; Lot Number AM03
84 units
Z-1347-2023
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC; UDI-DI: (01)00699753450868; Lot Number AM03
4940 units
Based on the official FDA remedy
What to do — step by step
Check for Leak
Inspect the oxygenator for signs of leakage at the arterial thermistor connection.
Contact Manufacturer
Reach out to Terumo Cardiovascular Systems Corporation for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide. Belgium, Canada, Costa Rica, Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1346-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1346-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.