Z-0348-2020Class II

Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

Name: Z-0348-2020 Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Creator: Basic Reset Inc.
Published: 2019-10-18
License: https://open.fda.gov/license/

Basic Reset Inc. / initiated 2019-10-18 / Completed / root cause: labeling and UDI

FDA source

Basic Reset Inc. began a recall of Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B) on 2019-10-18. FDA classified it as Class II and gives the reason as "FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0348-2020
Classification: Class II
Status: Completed
Initiated: 2019-10-18
Posted: 2019-11-08
Recalling firm: Basic Reset Inc.
Product: Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
Product code: N/A
Reason for recall: FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1257 units
Distribution: US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Product codes and lots: All product distributed between November 7, 2017 to September 4, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0348-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2020	Class II	Completed	FDA Mandated	2019-11-20	2019-11-08

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)