RegWardenFDA facility compliance records
Facility

NEPHROS, INC.

2 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 2 recalls; 2016: 1 inspections2’13’14’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

  • Subsystem, Water Purification
    Product code FIP (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5665

Recalls & enforcement

  • Class ITerminated2013-10-28
    Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
  • Class ITerminated2013-10-28
    Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

FDA inspections (1)

  • NAI2016-02-22
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NEPHROS, INC. (FEI 3003337893) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003337893-nephros-inc/

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