FDA Device recall Z-0487-2014
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are p…
- FDA Device
- Class I
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class I recall of Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are p… 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-0487-2014 |
| 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
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box 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 70-023 and 70-0238 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-0487-2014%22
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