Medical device recalls Moderate risk

Energy FX: a) original Aluminum b) sleek recalled over labeling errors

Recall date
October 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Basic Reset Inc. recalls Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Recall number
Z-0348-2020
FDA classification
Class II
Brand / firm
Basic Reset Inc.
Sold / distributed
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates

Why it was recalled

FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

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