1) Nephros SafeShower FH — Class I medical device recall Z-0488-2014
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-0488-2014 |
|---|---|
| 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 | 2017-06-28 |
| Distributed | Nationwide (US) |
| Model numbers | 10-0237, 70-0236, 70-0237 |
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
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-0488-2014. 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.