FDA Device recall Z-1576-2014
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 fr…
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II 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 fr… by William C Domb D M D A Professional, citing william Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1576-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-23 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | William C Domb D M D A Professional |
| Distribution | CA, FL, HI, IN, NC, TN, TX, WA |
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
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
Identifiers
| code_info | Lot # 10BT-091237 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1576-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.