CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled
Spectrum Medical is recalling Quantum PureFlow Standard Heat Exchanger High Flow 3/8, distributed nationwide in the US. The recall was initiated on 17 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3328-2026
- FDA event ID
- 99462
- Recalling firm
- Spectrum Medical, Mirandola
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2026
- FDA classified
- 29 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Medical Software
Timeline
| 17 Jul 2026 | Recall initiated by company | |
| 29 Sep 2026 | Classified by FDA | +74 days |
| 7 Oct 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to blood-to-glycol leak in the heat exchanger.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaCaliforniaFloridaKansasMassachusettsMarylandMichiganMissouriNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
Due to blood-to-glycol leak in the heat exchanger.
Which lots are affected?
Lot Code: 18051160301178 (HX55W-S0)
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99462This product is part of a recall event; the main page for the event is Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled | Spectrum Medical | Packaging Defects | Nationwide |
More recalls from Spectrum Medical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quantum PureFlow Standard Heat Exchanger High Flow 3/8 recalled | Spectrum Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Quantum Informatics - Vision / Live Vue Monitor recalled | Spectrum Medical | Device Malfunction | 38 states |
| Device | CLASS II | Quantum Informatics - Viper Monitor, Physiological, Patient recalled | Spectrum Medical | Device Malfunction | 38 states |
| Device | CLASS II | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type recalled | Spectrum Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Quantum Perfusion Systems for CPB recalled by Spectrum Medical | Spectrum Medical | Other | Nationwide |
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