FDA Medical Device Recalls (openFDA)
Nephros Inc: 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
- Recall number
- Z-0488-2014
- Recalling firm
- Nephros Inc
- 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 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
- Status
- Terminated
- Initiated
- 2013-10-28
- Posted
- 2013-12-17
- Terminated
- 2017-06-28
- Reason
- Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
- Root cause
- Device Design
- Action
- Nephros sent an Urgent Medical Device Recall letter dated October 28, 2013, with a return response form to all affected customers via UPS 2nd Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease shipment of the affected product immediately. Obtain an RGA number to return the new and used filters for credit. In addition, customers were instructed to immediately remove and discard all copies of the labeling materials that pertain to the affected product. Remove all electronic copies of these materials from any publicly accessible locations (e.g. website). Customers with questions were instructed to contact their Nephros representative or call 201-343-5202, ext 100. For questions regarding this recall call 201-343-5202. The letter was also posted at: http://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf Nephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.
- Quantity
- 3472 SS units; 513 FH units; 1219 HH units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ND
- Firm FEI
- 3003337893
- Firm city
- River Edge
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28