Basic Reset Energy FX products (Aluminum 100-3A and sleek 100-3B) were recalled by FDA due to being misbranded medical devices. All units sold between Nov 2017 and Sep 2019 are affected.
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Basic Reset's Energy FX products (Aluminum 100-3A and sleek 100-3B) were recalled because the FDA determined they were misbranded medical devices. This means the products were sold as medical devices without proper approval, which is illegal under FDA regulations.
The FDA found that Basic Reset marketed these products as medical devices without proper approval. This makes them adulterated and misbranded, which violates FDA regulations. The hazard comes from the product being sold as a medical device without the required safety and efficacy standards.
Anyone who purchased Energy FX products between November 2017 and September 2019. The risk is highest for users who intended the product as a medical device.
Check for Energy FX products labeled as 'Aluminum (100-3A)' or 'sleek (adult and kid & pet) (100-3B)'. All units sold between November 7, 2017 and September 4, 2019 are affected.
Identify if your Energy FX product is labeled as 'Aluminum (100-3A)' or 'sleek (adult and kid & pet) (100-3B)' and was purchased between November 7, 2017 and September 4, 2019.
The FDA determined that Basic Reset marketed these products as medical devices without proper approval, making them adulterated and misbranded.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the description.
All Energy FX products were sold between November 7, 2017 and September 4, 2019.
We’ve drafted a message you can send Basic Reset to request your refund or repair — edit it as you like.
Subject: Recall Z-0348-2020 — Basic Reset Basic Reset Hello, I own a Basic Reset that is covered by recall Z-0348-2020 from Basic Reset. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.