QUADROX-i Adult — Class II medical device recall Z-1659-2023
Ongoing recall by Maquet Medical Systems USA, reported 2023-06-07, distributed nationwide. Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the ste
| Recall number | Z-1659-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2023-05-18 |
| Classified | 2023-05-30 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04058863017341, 04058863017372, 04058863019147 |
| Model numbers | 4058863017341, 4058863017372, 4058863019147HMO, 70000-USA, 701067820, 701067820HMO, 701067823, 701067829, 71000-USA |
Product
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
Reason for recall
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
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-1659-2023. 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.