CLASS I Device recall · Reported 25 Dec 2013 · FDA Enforcement Report

Nephros SafeShower FH - 15 filters recalled

Nephros is recalling Nephros SafeShower FH - 15 filters per, distributed nationwide in the US. The recall was initiated on 28 Oct 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesItem Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents

Quantity recalled3472 SS units; 513 FH units; 1219 HH units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0488-2014
FDA event ID: 66736
Recalling firm: Nephros, River Edge, NJ
Classification: Class I
Status: Terminated
Recall initiated: 28 Oct 2013
FDA classified: 17 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Oct 2013	Recall initiated by company
17 Dec 2013	Classified by FDA	+50 days
25 Dec 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 66736

This product is part of a recall event; the main page for the event is SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue recalled.

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013	CLASS I	SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue recalled	Nephros	Packaging Defects	Nationwide

More recalls from Nephros

All 3

Reported	Class	Recall	Company	Reason	Where
25 Dec 2013Device	CLASS I	SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue recalled	Nephros	Packaging Defects	Nationwide
25 Dec 2013Device	CLASS I	Dual Stage Ultra Filter (DSU) Brochure Document recalled by Nephros	Nephros	Other	Nationwide

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