BEQ-HMOD70000-USA/QUADROX-iD — Class II medical device recall Z-1635-2023
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-1635-2023 |
|---|---|
| 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 | 15,880 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 04058863019024 |
| Lot numbers | BEQ-HMOD70000-USA/QUADROX-ID |
| Model numbers | 701067859 |
Product
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
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-1635-2023. 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.