Basic Reset Energy FX Recalled for Adulteration and Misbranding
Basic Reset Inc. is recalling Energy FX products because FDA determined the marketing claims rendered the product a medical device that was adulterated and misbranded.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, deaths, or specific injuries, but the product is deemed adulterated and misbranded, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Basic Reset Inc. is recalling Energy FX products, including the original Aluminum (100-3A) and sleek (adult and kid & pet) (100-3B) models. The recall involves 1,257 units distributed between November 7, 2017, and September 4, 2019.
The U.S. Food and Drug Administration determined that the marketing claims surrounding the product rendered it a medical device. Consequently, the product was found to be adulterated and misbranded. The agency classified this recall as Class II.
The affected products were distributed in the United States, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, the Philippines, Greece, the United Kingdom, Israel, Nigeria, Hungary, and the United Arab Emirates. Consumers should stop using the product and contact Basic Reset Inc. for instructions on how to return it.
The recalled product
- Product
- Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
- Manufacturer
- Basic Reset Inc.
- Hazard
- Affected units
- 1,257
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 (3)
- All product distributed between November 7
- 2017 to September 4
- 2019
Distribution
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