openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 2
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
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
These labels are deterministic app interpretations, not FDA categories.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Code information
Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
Distribution pattern
Nationwide Distribution
device · product 2 of 2
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
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
These labels are deterministic app interpretations, not FDA categories.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Code information
Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
