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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The issue is related to marketing claims and regulatory compliance rather than a physical defect or contamination hazard.
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 SafeSho
- Manufacturer
- Nephros Inc
- Hazard
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 →Related recalls
Same manufacturer · Nephros Inc
See all →- LowNephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
FDA (Devices) · 2013-12-25
- SevereNephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing
FDA (Devices) · 2013-12-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02