Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing
Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products 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 source explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
Plain-English summary
Nephros Inc. is recalling 3,742 units of Nephros SafeSpout water filters. The products were distributed nationwide. The filters are packaged in Tyvek pouches inside cardboard boxes, with 15 filters per box. The specific item numbers are 70-023 and 70-0238, and the affected document numbers are 60-0237, 60-3004, and 60-3005.
The recall was initiated because promotional materials for these non-medical water filtration products were determined to promote claims that constitute marketing the product as a medical device. The Nephros SafeSpout and SafeShower 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 possess these products should stop using them and contact Nephros Inc. for instructions on how to return the items or obtain a refund. The recall is classified as Class I by the FDA due to the regulatory violation regarding marketing claims.
The recalled product
- Product
- Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended…
- Manufacturer
- Nephros Inc
- Hazard
- Affected units
- 3,742
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 70-023 and 70-0238 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
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See all →- SevereNephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
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- SevereNephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations
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