Spectrum Medical SRL recall: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W and 1 more product
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W and 1 more product – 9448; 3232. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on July 17, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W and 1 more product |
| Brand | Spectrum Medical SRL |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 17, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 9448; 3232 |
| Recall ID | 99462 |
Recalled products (2)
- 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
- FDA recall number
- Z-3327-2026
- Codes, lots and dates
- Lot Code: 18051160302205 (HX55V-S0W)
- Quantity
- 9448
- Classification
- Class II
- 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
- FDA recall number
- Z-3328-2026
- Codes, lots and dates
- Lot Code: 18051160301178 (HX55W-S0)
- Quantity
- 3232
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99462
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Mirandola, Italy
Why it was recalled
The reason the FDA lists: “Due to blood-to-glycol leak in the heat exchanger.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99462, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Spectrum Medical SRL Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W recalled?
Yes. Spectrum Medical SRL recalled it on July 17, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to blood-to-glycol leak in the heat exchanger.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.