The Recall Desk

Manufacturer

SPECTRUM MEDICAL SRL

2 recalls in our database name SPECTRUM MEDICAL SRL as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
2
Most recent
2026-10-07

Of the 2 recalls from SPECTRUM MEDICAL SRL we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • SevereFDA (Devices)·Z-3328-2026·2026-10-07

    Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk

    Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers due to a risk of blood-to-glycol leaks during cardiopulmonary bypass procedures.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3327-2026·2026-10-07

    Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk

    Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers because a defect may cause blood to leak into the glycol heat transfer fluid.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide