Z-0488-2014Class I

1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box...

Name: Z-0488-2014 1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box...
Creator: Nephros Inc
Published: 2013-10-28
License: https://open.fda.gov/license/

Nephros Inc / initiated 2013-10-28 / Terminated / root cause: design

FDA source

Nephros Inc began a recall of 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... on 2013-10-28. FDA classified it as Class I and gives the reason as "Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0488-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-12-17
Terminated: 2017-06-28
Recalling firm: Nephros Inc
Product: 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 code: ND
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.
Root cause tag: design
FDA root cause: Device Design
Action: Nephros sent an Urgent Medical Device Recall letter dated October 28, 2013, with a return response form to all affected customers via UPS 2nd Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease shipment of the affected product immediately. Obtain an RGA number to return the new and used filters for credit. In addition, customers were instructed to immediately remove and discard all copies of the labeling materials that pertain to the affected product. Remove all electronic copies of these materials from any publicly accessible locations (e.g. website). Customers with questions were instructed to contact their Nephros representative or call 201-343-5202, ext 100. For questions regarding this recall call 201-343-5202. The letter was also posted at: http://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf Nephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.
Quantity in commerce: 3472 SS units; 513 FH units; 1219 HH units
Distribution: Nationwide Distribution
Product codes and lots: Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0487-2014	Class I	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17
Z-0488-2014	Class I	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

Product code ND

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)