Spectrum Medical Ltd. recalls
6 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Spectrum Medical Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-10-07FDA-DeviceClass IIQuantum PureFlow heat exchanger recalled for blood-to-glycol leak
Spectrum Medical's Quantum PureFlow Standard Heat Exchanger (model HX55W-S0) may develop leaks that allow glycol coolant to mix with blood during cardiopulmonary bypass surgery. This device is used in operating rooms to regulate blood temperature during heart procedures. The affected lot (18051160301178) was distributed nationwide.
- 2026-10-07FDA-DeviceClass IIQuantum PureFlow heat exchanger recalled for blood-to-glycol leak
Spectrum Medical's Quantum PureFlow Standard Heat Exchanger, used during heart-lung bypass surgery, can develop leaks that allow glycol coolant to mix with blood. The affected devices are model HX55V-S0W from lot code 18051160302205. No injuries have been reported.
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