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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68143

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

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Event summary

Timeline bucket
April 23, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
William C. Domb, D.M.D., A Professional Corporation

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

Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to ozone occurs in a reaction cell excited by a high voltage potential. A control circuit allows the user to manually adjust the ozone output between 40-100% of its rated output.

Z-1576-2014
Recall number
Z-1576-2014
Initiated
April 23, 2014
Classification
Class II
Status
Terminated
Quantity
16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.

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

William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.

Code information

Lot # 10BT-091237

Distribution pattern

Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.