Medical DeviceOct 7, 2026
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W recall — FDA Z-3327-2026
Due to blood-to-glycol leak in the heat exchanger.
Class IIFDA: OngoingSPECTRUM MEDICAL SRL
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceOct 7, 2026
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recall — FDA Z-3328-2026
Due to blood-to-glycol leak in the heat exchanger.
Class IIFDA: OngoingSPECTRUM MEDICAL SRL
Understanding this recall history
This page summarizes recall records in which the official source identifies SPECTRUM MEDICAL SRL as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.