Nephros SafeSpout, SafeShower Recall Issued Due to Bacteria Risk

Following reports of serious infections, including at least one death, a recall is being issued for Nephros water filter products used for drinking water and body washing, as there appears to be a risk that users may be exposed to a risk of bacteria or viruses.

A Nepros SafeSpout and SafeShower recall was categorized by the FDA as a Class I medical device recall this week, suggesting that continued use of the product may pose a risk of serious injury or death.

The water filters are placed on the end of a standard sink or showerhead to filter water before drinking or bathing.

Nephros issued a recall for the non-medical water filtration products in October 2013, after the FDA informed the manufacturer that promotional materials made claims that result in the products being considered a medical device. However, according to information released by the FDA this week, the Nephros SafeSpout and Nephros SafeShower may pose a serious health risk for consumers if the fiber filter or sealing compound, which holds the fiber in place, break apart.

At least two reports of problems with the Nephros water filter products have been reported to date, including at least one infection and one death.

The FDA indicates that if the filter becomes dislodged, it may result in exposure to harmful bacteria or viruses, which could result in infection or death.

The affected Nephros product models are SafeSpout, SafeSpout HH, and SafeShower FH. These products were distributed from October 2011, through September 2013. The promotional products being recalled include the 60-0237 Nephros Ultra Filters Technical Dossier, 60-3003 Nephros In-Line DSU Filter Brochure, and the In-Line Dual Stage Ultra Filter with item numbers 70-0230, 70-0231, 70-0232, 70-0234, 70-0235 that were distributed from January 2011, through October 2013. The products were manufactured by Nephros Inc., located in River Edge, New Jersey.

On October 28, Nephros sent a customer recall letter and return packet via UPC to all known customers to remove and return the affected filters. Nephros is also encouraging all customers to discard all promotional products. Customers may contact Nephros at 1-201-343-5202 for further questions and concerns.