CLASS I Device recall · Reported 25 Dec 2013 · FDA Enforcement Report
SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue recalled
Nephros is recalling SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at, 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
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-0487-2014
- 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
- Packaging Defects
- 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 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
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 70-023 and 70-0238 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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Nephros SafeShower FH - 15 filters recalled | Nephros | Other | Nationwide |
More recalls from Nephros
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Nephros SafeShower FH - 15 filters recalled | Nephros | Other | Nationwide |
| Device | CLASS I | Dual Stage Ultra Filter (DSU) Brochure Document recalled by Nephros | Nephros | Other | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |