CLASS I Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
Dual Stage Ultra Filter (DSU) Brochure Document recalled by Nephros
Nephros is recalling Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2, distributed nationwide in the US. The recall was initiated on 28 Oct 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0490-2014
- FDA event ID
- 66735
- Recalling firm
- Nephros, River Edge, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 Oct 2013
- FDA classified
- 17 Dec 2013
- Reported
- 25 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Oct 2013 | Recall initiated by company | |
| 17 Dec 2013 | Classified by FDA | +50 days |
| 25 Dec 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Why was it recalled?
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Which lots are affected?
Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)
Where was it sold?
USA Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nephros
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Nephros SafeShower FH - 15 filters recalled | Nephros | Other | Nationwide |
| Device | CLASS I | SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue recalled | Nephros | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |