Lower riskMedical device recall · FDA · Published March 22, 2021
Qura Spectrum Medical Quantum Standard Heat Exchanger Recall: Sterile Labeling Issue
Qura recalls Spectrum Medical Quantum Standard heat exchangers with specific batch numbers due to potential inadequate sterilization and lack of US 510(k) clearance.
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.
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Contact the company
📍Recalling firmQURA S.R.L.Via Di Mezzo 23 · Mirandola, Italy
“Qura Spectrum Medical Quantum Standard Heat Exchanger Recall: Sterile Labeling Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63019-qura-spectrum-medical-quantum-standard-heat-exchanger-recall-sterile-labeling. Based on FDA recall #Z-2277-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2021%22&limit=1).
QURA S.R.L. recalled Spectrum Medical Quantum Standard heat exchangers due to inadequate sterilization and lack of FDA clearance, the FDA said on March 22, 2021.
How to tell if you have it
Brand: Qura
Product: Spectrum Medical Quantum Standard heat exchanger
Batch Numbers: B000129, C000415, C000416, C000417
Units affected: 1088
The hazard
The 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.
Context
GovInfoNow's records show other recent recalls of similar products include Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk (2026-07-17), Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (2026-01-07), and Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (2026-04-23).
How to tell if you have this one
Check the batch number on the heat exchanger. The recalled units have batch numbers B000129, C000415, C000416, or C000417.
Brand
Qura
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Batch Number
Identify the batch number on the heat exchanger to determine if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of South Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2277-2021 (March 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2277-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.