Spectrum Medical Quantum Standard heat exchanger — Class II medical device recall Z-2277-2021
Terminated recall by QURA S.R.L., reported 2021-08-18, distributed nationwide. Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported t
| Recall number | Z-2277-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QURA S.R.L., Mirandola, N/A, Italy |
| Recall initiated | 2021-03-22 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2024-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,088 units |
| Reason classes | labeling, sterility |
| Lot numbers | B000129, C000415, C000416, C000417 |
Product
Spectrum Medical Quantum Standard heat exchanger
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2277-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.