Quantum PureFlow Heat Exchanger Recalled Over Contamination Risk: Health Canada

Health Canada has classified a Type II recall for the Quantum PureFlow Standard Heat Exchanger High Flow, a surgical device manufactured by Spectrum Medical Srl, after the company identified a defect that could allow blood to leak into the unit’s glycol cooling compartment. The recall, dated 2026-08-17 and published on 2026-09-02, carries the identification number RA-82586 and falls under Health Canada’s category for general and plastic surgery medical devices.

The heat exchanger is a component used in heater-cooler units, devices that regulate a patient’s blood temperature during certain surgical procedures by circulating glycol for thermoregulation. According to Health Canada, blood-to-glycol leakage was identified in the heat exchanger during a procedure, raising the possibility that the glycol compartment of the heater-cooler could become contaminated with blood.

What Products Are Being Recalled?

The recall covers two variants of the Quantum PureFlow Standard Heat Exchanger High Flow, sold under model numbers HX55V-S0W (3/8W configuration) and HX55V-S0 (3/8 configuration). The affected lot or serial numbers are as follows:

• Model HX55V-S0W: lot numbers H000950, H000690, H000832 and H000629
• Model HX55V-S0: lot numbers G002139, H000193 and H000221

All units carrying these lot numbers fall within the scope of the notice. Healthcare facilities that use this equipment are advised to cross-check their inventory against the specific lot and model numbers listed above, since Health Canada’s alert does not indicate that the entire product line is affected.

What Went Wrong?

Health Canada’s notice states plainly that blood-to-glycol leakage was identified in the heat exchanger during use. Because glycol continuously circulates through the heater-cooler for thermoregulation purposes, a breach between the blood pathway and the glycol compartment creates a risk that blood could contaminate the internal workings of the machine. That, in turn, raises concerns about cross-contamination risks for future patients if the equipment is not properly assessed, cleaned or replaced. The agency describes the issue as significant enough that direct customer communication was deemed necessary to inform users of both the potential for leakage and the possible resulting contamination.

Who Should Be Concerned?

This recall is directed at a healthcare audience rather than the general public. Hospitals, surgical centres and clinical staff who operate heater-cooler systems fitted with the Quantum PureFlow Standard Heat Exchanger High Flow are the primary parties affected. Patients themselves are not asked to take any direct action, since the device is clinical equipment rather than a consumer product, but the underlying safety concern touches anyone undergoing a procedure that relies on this equipment for blood temperature regulation.

What Consumers Need to Do Now

Health Canada’s guidance for this notice is limited to one instruction: healthcare facilities and staff should contact the manufacturer, Spectrum Medical Srl, if they require additional information. The company is based in Mirandola, in the Modena province of Italy. Facilities that have any of the listed lot numbers in active use are expected to follow up directly with Spectrum Medical for further instructions on inspection, servicing or replacement of the affected heat exchangers.

Regulatory Response

Health Canada has published the notice under its Health Products Recall category, with an audience designation of ‘Healthcare’ and a recall class of Type II, indicating a moderate risk of adverse health consequences from continued use of the affected units. The listing was issued in coordination with Spectrum Medical Srl and remains publicly searchable through Health Canada’s recalls and safety alerts database under identification number RA-82586.

As of publication, Health Canada has not reported any confirmed patient harm linked to this specific defect, but the agency’s decision to classify the notice as a formal recall reflects the seriousness of a blood-contamination pathway in equipment used during surgery. Facilities are encouraged to act promptly given the clinical setting in which these devices operate.