FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use
William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is the use of an unapproved device, which fits the criteria for a moderate severity recall involving regulatory non-compliance without reported harm.
Plain-English summary
William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12. The recall is being conducted because the device is not approved or cleared by the FDA for medical use.
The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge, capable of delivering up to 1 gram of ozone per hour from pure oxygen. The affected units are identified by Lot # 10BT-091237.
The recalled devices were distributed worldwide, including in the United States (IN, HI, WA, TN, CA, TX, FL, NC) and internationally to Canada, Portugal, and Ireland. Consumers and healthcare providers should stop using the device and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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…
- Category
- Medical Device — Ozone Generator
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 10BT-091237
Distribution
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