CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Capiox NX19 Hollow Fiber Oxygenator recalled

Terumo Cardiovascular Systems is recalling Capiox NX19 Hollow Fiber Oxygenator, distributed nationwide in the US. The recall was initiated on 1 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: (01)00699753450868; Lot Number AM03

Quantity recalled84 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1346-2023
FDA event ID: 91775
Recalling firm: Terumo Cardiovascular Systems, Elkton, MD
Classification: Class II
Status: Ongoing
Recall initiated: 1 Mar 2023
FDA classified: 5 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

1 Mar 2023	Recall initiated by company
5 Apr 2023	Classified by FDA	+35 days
12 Apr 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE

Where it was distributed

US Nationwide. Belgium, Canada, Costa Rica, Thailand.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: (01)00699753450868; Lot Number AM03

Where was it sold?

US Nationwide. Belgium, Canada, Costa Rica, Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 91775

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Capiox FX25 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide

More recalls from Terumo Cardiovascular Systems

All 222

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Device	CLASS II	CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems	Terumo Cardiovascular Systems	Labeling Errors	Nationwide
9 Apr 2025Device	CLASS II	Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled	Terumo Cardiovascular Systems	Device Malfunction	6 states
10 Apr 2024Device	CLASS II	Cardiovascular Procedure Kits that include High Crack Check recalled	Terumo Cardiovascular Systems	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS II	Capiox RX15 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide
12 Apr 2023Device	CLASS II	Capiox FX25 Hollow Fiber Oxygenator recalled	Terumo Cardiovascular Systems	Packaging Defects	Nationwide

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