Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spectrum Medical Quantum Standard heat exchanger Recalled by QURA S.R.L. Due to Product labeled as sterile may not have been...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QURA S.R.L. directly.
Affected Products
Spectrum Medical Quantum Standard heat exchanger
Quantity: 1088 units
Why Was This Recalled?
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About QURA S.R.L.
QURA S.R.L. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report