Enaly 1000 BT-12 Ozone Generator — Class II medical device recall Z-1576-2014
Terminated recall by William C. Domb, D.M.D., A Professional Corporation, reported 2014-05-21, distributed in CA, FL, HI, IN, NC, TN, TX, WA. William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FD
| Recall number | Z-1576-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | William C. Domb, D.M.D., A Professional Corporation, Upland, CA, United States |
| Recall initiated | 2014-04-23 |
| Classified | 2014-05-09 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2015-01-08 |
| Distributed | CA, FL, HI, IN, NC, TN, TX, WA |
| Countries outside the US | CA, IE, PT |
| Quantity | 16 units |
| Reason classes | unapproved product |
| Lot numbers | 10BT-091237 |
| Model numbers | 1000BT-12 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1576-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.