Nephros Dual Stage Ultra Filter — Class I medical device recall Z-0490-2014
Terminated recall by Nephros Inc, reported 2013-12-25, distributed nationwide. Promotional materials for non-medical water filtration products were determined to promote claims which consti
| Recall number | Z-0490-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephros Inc, River Edge, NJ, United States |
| Recall initiated | 2013-10-28 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2016-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,367 untis |
| Model numbers | 70-0230 |
Product
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
Reason for recall
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
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-0490-2014. 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.