Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0 Recalled by Nephros Inc Due to Promotional materials for non-medical water filtration products were...

Date: October 28, 2013
Company: Nephros Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nephros Inc directly.

Affected Products

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.

Quantity: 3,367 untis with affected labeling

Why Was This Recalled?

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nephros Inc

Nephros Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report