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All product recalls associated with Terumo Cardiovascular Systems Corporation.
Total Recalls
1000
Past Year
581
Class I (Serious)
91
Most Recent
Dec 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.