FDA Device recall Z-0490-2014
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilt…
- FDA Device
- Class I
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class I recall of Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilt… 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-0490-2014 |
| 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 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.
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 #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all) |
|---|
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-0490-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.