Agency classClass IOur severity:Severe FDA (Devices)·Z-0488-2014·Announced 2013-12-25

Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

Plain-English summary

Nephros Inc. is recalling Nephros SafeShower FH, SafeShower HH, and SafeSpout water filtration products. The recall involves 3,472 SafeSpout units, 513 SafeShower FH units, and 1,219 SafeShower HH units. These products were distributed nationwide.

The recall was initiated because promotional materials for these non-medical water filtration products contained claims that constituted marketing the products as medical devices. The products are intended to filter water for washing and drinking and are installed at the end of a standard sink faucet or shower hose.

Consumers who purchased these products should stop using them and contact Nephros Inc. for further instructions. The recall is based on regulatory compliance issues regarding product classification and marketing claims.

The recalled product

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…
Manufacturer: Nephros Inc
Category: Medical Device — Water Filtration
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Nephros Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Nephros Inc

See all →

Severe
Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
FDA (Devices) · 2013-12-25
Severe
Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing
FDA (Devices) · 2013-12-25

Same hazard · mis labeling