Nephros Inc: Medical Device Recall in 2013 - (Recall #: Z-0488-2014)

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:

1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy 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-0488-2014

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: 3472 SS units; 513 FH units; 1219 HH units

Code Information:

Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated