Z-0348-2020 Class II
FDA device recall Z-0348-2020 was initiated by Basic Reset Inc. on Oct 18, 2019 and is designated Class II. Reason for recall: FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded. Affected quantity: 1257 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2019
- Initiation Date
- Oct 18, 2019
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 1257 units
Product Description
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.
Distribution Pattern
US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates
Code Information
All product distributed between November 7, 2017 to September 4, 2019
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0348-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026