{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "123218",
      "product_res_number": "Z-0488-2014",
      "event_date_initiated": "2013-10-28",
      "event_date_posted": "2013-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-06-28",
      "res_event_number": "66736",
      "product_code": "ND",
      "product_description": "1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 \r\n2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237\r\n\r\nManufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661\r\n\r\nAssembled at MEDICA 41036 Medolla, Italy \r\n\r\nThe 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",
      "code_info": "Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents",
      "firm_fei_number": "3003337893",
      "recalling_firm": "Nephros Inc",
      "address_1": "41 Grand Ave",
      "city": "River Edge",
      "state": "NJ",
      "postal_code": "07661-1947",
      "additional_info_contact": "Ms. Eileen Sukumaran\n201-343-5202",
      "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.",
      "root_cause_description": "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.\r\nFor questions regarding this recall call 201-343-5202.\r\n\r\nThe letter was also posted at:\r\nhttp://www.nephros.com/download/news/SafeSpout_SafeShower_Recall_Letters.pdf\r\n\r\nNephros sent a new recall letter dated 2/20/204 as they determined they have additional customers.",
      "product_quantity": "3472 SS units; 513 FH units; 1219 HH units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {}
    }
  ]
}