Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CAPIOX FX25 Hollow Fiber Oxygenator Recalled by Terumo Cardiovascular Systems Corporation Due to Some Capiox NX, RX and FX Oxygenators may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Cardiovascular Systems Corporation directly.
Affected Products
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Quantity: 4940 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report