Due to blood-to-glycol leak in the heat exchanger.
✎ GovInfoNow plain-language explainer
Spectrum Medical SRL is recalling the Quantum PureFlow Standard Heat Exchanger because of a potential leak between the blood and glycol circuits. This device is used during cardiopulmonary bypass procedures to heat or cool blood. The specific recalled units have lot code 18051160302205. Read more at govinfonow.com/recall/1449549-spectrum-medical-srl-recalls-brand-name-quantum-pureflow-product-name.
“Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449549-spectrum-medical-srl-recalls-brand-name-quantum-pureflow-product-name. Based on FDA recall #Z-3327-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3327-2026%22&limit=1).
The FDA announced on July 17, 2026, that Spectrum Medical SRL is recalling the Quantum PureFlow Standard Heat Exchanger due to a potential blood-to-glycol leak. This voluntary Class II recall affects units distributed nationwide.
How to tell if you have it
Brand: Spectrum Medical
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
Model/Catalog Number: HX55V-S0W
Lot Code: 18051160302205
The hazard
The recall is due to a blood-to-glycol leak in the heat exchanger, according to the FDA. The device is intended for use with compatible Heater/Cooler systems during routine cardiopulmonary bypass procedures.
Context
GovInfoNow's records show Spectrum Medical has been involved in other recent recalls, including a July 6, 2026, recall of Sodium Chloride Injection for infection risk. Other recent recalls of similar products include the June 24, 2026, ICU Medical Hotline Fluid Warming Set Recall and the August 10, 2026, Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall.
How to tell if you have this one
Look for the Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W with Model/Catalog Number HX55V-S0W. Check the lot code on the packaging; the recalled units have lot code 18051160302205.
Brand
Spectrum Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI.
Recall number
Product, codes & lots
Quantity
Z-3327-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A; Lot Code: 18051160302205 (HX55V-S0W)
9448
Z-3328-2026
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A; Lot Code: 18051160301178 (HX55W-S0)
3232
Based on the official FDA remedy
What to do — step by step
Stop Using Recalled Units
Do not use any Quantum PureFlow Standard Heat Exchangers with lot code 18051160302205.
Contact Manufacturer for Remedy
The recall record does not specify the current remedy or return instructions; contact Spectrum Medical SRL directly for further guidance.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Kansas, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3327-2026 (July 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3327-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.