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 | 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose |
| Quantity | 3472 SS units; 513 FH units; 1219 HH units |
| Distribution | Nationwide Distribution |
| Initiated | 2013-10-28 |
| Classified | 2013-12-17 |
| Terminated | 2017-06-28 |
| Recall number | Z-0488-2014 |
| 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-0488-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66736/
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