QUADROX -i Neonatal — Class II medical device recall Z-1640-2023
Ongoing recall by Maquet Medical Systems USA, reported 2023-06-07, distributed nationwide. 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's steri
| Recall number | Z-1640-2023 |
|---|---|
| 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 | 2023-05-26 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 04058863154473, 04058863154558 |
| Model numbers | 10000-USA, 11000-USA, 4058863154473HMO, 4058863154558, 701070412, 701070412HMO, 701070416 |
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Reason for recall
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product 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-1640-2023. 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.