Energy FX: a) original Aluminum — Class II medical device recall Z-0348-2020
Completed recall by Basic Reset Inc., reported 2019-11-20, distributed in PR, VI. FDA determined that marketing claims surrounding product rendered product a medical device which was adulterat
| Recall number | Z-0348-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Basic Reset Inc., Hendersonville, TN, United States |
| Recall initiated | 2019-10-18 |
| Classified | 2019-11-08 |
| Reported by FDA | 2019-11-20 |
| Distributed | PR, VI |
| Countries outside the US | AE, AU, CA, GB, GR, HU, IL, MX, NG, PH |
| Quantity | 1,257 units |
| Reason classes | labeling |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0348-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.