FDA Medical Device Recalls (openFDA)
William C. Domb, D.M.D., A Professional Corporation: 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.
- Recall number
- Z-1576-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-04-23
- Posted
- 2014-05-09
- Terminated
- 2015-01-08
- Reason
- William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
- 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 bill@smilestudio.com from Monday-Friday at 8am-5pm Pacific Time. For questions regarding this recall call (909) 949-2968.
- Quantity
- 16 units
- Distribution
- Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
- Lot, serial or model codes
- Lot # 10BT-091237
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EIA
- Firm FEI
- 3009424396
- Firm city
- Upland
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28