FDA Medical Device Recalls (openFDA)
Basic Reset Inc.: Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
- Recall number
- Z-0348-2020
- Recalling firm
- Basic Reset Inc.
- Product
- Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
- Status
- Completed
- Initiated
- 2019-10-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
- Root cause
- No Marketing Application
- Action
- The firm initiated the recall on 09/23/2019 by email and followed with a second letter on 10/18/2019. The letter requests the consignee discard/destroy the product.
- Quantity
- 1257 units
- Distribution
- US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
- Lot, serial or model codes
- All product distributed between November 7, 2017 to September 4, 2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3007197806
- Firm city
- Hendersonville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28