Class I — Nephros Inc
| Recalling firm | Nephros, INC. |
|---|---|
| Registered facility | NEPHROS, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device. |
| 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. |
| Quantity | 3,367 untis with affected labeling |
| Distribution | USA Nationwide Distribution |
| Initiated | 2013-10-28 |
| Classified | 2013-12-17 |
| Terminated | 2016-07-06 |
| Recall number | Z-0490-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Nephros Inc (Z-0490-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66735/
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