CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Energy FX: a) original Aluminum (100-3A) b) sleek (adult recalled
Basic Reset is recalling Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B), distributed in Puerto Rico. The recall was initiated on 18 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0348-2020
- FDA event ID
- 84117
- Recalling firm
- Basic Reset, Hendersonville, TN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Oct 2019
- FDA classified
- 8 Nov 2019
- Reported
- 20 Nov 2019
- Type
- FDA Mandated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 18 Oct 2019 | Recall initiated by company | |
| 8 Nov 2019 | Classified by FDA | +21 days |
| 20 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Product as listed by the FDA
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Where it was distributed
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Questions about this recall
Why was it recalled?
FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Which lots are affected?
All product distributed between November 7, 2017 to September 4, 2019
Where was it sold?
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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