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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66735

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 28, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Nephros Inc

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

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 1

Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.

Z-0490-2014
Recall number
Z-0490-2014
Initiated
October 28, 2013
Classification
Class I
Status
Terminated
Recalling firm
Nephros Inc
Quantity
3,367 untis with affected labeling

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235 Document numbers 60-0237 (all) and 60-3003 (all)

Distribution pattern

USA Nationwide Distribution