QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator — Class II medical device recall Z-2262-2013
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2013-10-02, distributed nationwide. The manufacturer has conducted a review of the results of product testing performed during the last twelve mon
| Recall number | Z-2262-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2013-08-15 |
| Classified | 2013-09-20 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2017-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,182 units |
| Reason classes | potency |
| Lot numbers | 70081567, 70082663, 70083974 |
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Reason for recall
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
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-2262-2013. 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.