FDAClass IIMay 21, 2014

Enaly 1000 BT-12 Ozone Generator recall

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…

Why was Enaly 1000 BT-12 Ozone Generator recalled?

William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 10BT-091237

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…
Recalling firm
William C. Domb, D.M.D., A Professional Corporation
Quantity
16 units
Distribution
Worldwide Distribution - USA including IN, HI, WA, TN, CA, TX, FL, NC, and Internationally to Canada, Portugal, and Ireland.
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls