Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 re

U.S. FDA — Device Enforcement · United States · 2014-04-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1576-2014
Date of alert: 2014-04-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: William C. Domb, D.M.D., A Professional Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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