FDA recall Z-0348-2020

Basic Reset Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates

Key facts

Status
Completed
Initiation date
2019-10-18
Report date
2019-11-20
Voluntary/Mandated
FDA Mandated
Location
Hendersonville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2020