FDA Device recall Z-0488-2014
1) Nephros SafeShower FH - 15 filters per box
- FDA Device
- Class I
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class I recall of 1) Nephros SafeShower FH - 15 filters per box by Nephros, citing promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0488-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-10-28 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nephros |
| Distribution | US |
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
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Identifiers
| code_info | Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0488-2014%22
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