Z-1576-2014Class II

Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up...

Name: Z-1576-2014 Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up...
Creator: William C. Domb, D.M.D., A Professional Corporation
Published: 2014-04-23
License: https://open.fda.gov/license/

William C. Domb, D.M.D., A Professional Corporation / initiated 2014-04-23 / Terminated

FDA source

William C. Domb, D.M.D., A Professional Corporation began a recall of 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... on 2014-04-23. FDA classified it as Class II and gives the reason as "William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1576-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-23
Posted: 2014-05-09
Terminated: 2015-01-08
Recalling firm: William C. Domb, D.M.D., A Professional Corporation
Product: 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.
Product code: EIA Unit, Operative Dental
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.
FDA root cause: No Marketing Application
Action: William Domb, DMD sent an Urgent Medical Device Recall letter on April 23, 2014, to all affected customers who purchased the Enaly 1000BT-12 Ozone Generator. The letter informed the customers of the problems identified, risk to health, and the actions to be taken. Customers were instructed to discontinue use of the Enaly 1000 BT-12 Ozone Generator and return their units to the following address: William Domb, DMD 190 N Mountain Avenue Upland, CA 91786 Customers were also instructed to complete the Medical Device Field Action Return Response form. For questions customers should contact William Domb at (909) 949-2968 or by email at [email protected] from Monday-Friday at 8am-5pm Pacific Time. For questions regarding this recall call (909) 949-2968.
Quantity in commerce: 16 units
Distribution: Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
Product codes and lots: Lot # 10BT-091237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1576-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1576-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

Product code EIA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)