Nephros Inc: Medical Device Recall in 2013 - (Recall #: Z-0487-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: October 28, 2013

Date Posted: December 25, 2013

Recall Number: Z-0487-2014

Event ID: 66736

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.

Status: Terminated

Product Quantity: 3742 units

Code Information:

Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated