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All product recalls associated with Terumo Cardiovascular Systems Corporation.
Total Recalls
1000
Past Year
1000
Class I (Serious)
127
Most Recent
Jan 2026
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.
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.