Quantum PureFlow Standard Heat Exchanger
The Quantum PureFlow Standard Heat Exchanger can leak blood-to-glycol.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
SPECTRUM MEDICAL SRL recalled Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W and Quantum PureFlow Standard Heat Exchanger High Flow 3/8 due to blood-to-glycol leak in the heat exchanger. The recall began July 17, 2026, and was added to FDA's Enforcement Report on September 29, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and model/catalog number listed under your product.
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
- UDI-DI
- 18051160302205
- Model/Catalog number
- HX55V-S0W
Quantum PureFlow Standard Heat Exchanger High Flow 3/8
- UDI-DI
- 18051160301178
- Model/Catalog number
- HX55W-S0
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, California, Florida, Kansas Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
- Event ID
- 99462
- Recall numbers
- Z-3327-2026 to Z-3328-2026
- Company
- SPECTRUM MEDICAL SRLMirandola, Italy
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
