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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69386

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 29, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dharma Research, 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

2 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 2

Dharma Cavity Varnish with Fluoride

Z-0475-2015
Recall number
Z-0475-2015
Initiated
September 29, 2014
Classification
Class II
Status
Terminated
Recalling firm
Dharma Research, Inc.
Quantity
2,842

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA inspection, it was found that the products are being marketed without a cleared 510k.

Code information

All Lots - Item #14-00015

Distribution pattern

Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.

device · product 2 of 2

Dharma Cavity Varnish 15mL

Z-0476-2015
Recall number
Z-0476-2015
Initiated
September 29, 2014
Classification
Class II
Status
Terminated
Recalling firm
Dharma Research, Inc.
Quantity
916

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the products are marketed without a cleared 510k.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Code information

All Lots - Item # 14-00016

Distribution pattern

Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.