Exact FDA event identifier

Event 84117

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 18, 2019
Product types: Device
Classifications: Class II
Statuses: Completed
Recalling firm wording: Basic Reset Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0348-2020

Recall number: Z-0348-2020
Initiated: October 18, 2019
Classification: Class II
Status: Completed
Recalling firm: Basic Reset Inc.
Quantity: 1257 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

misbranded

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

FDA determined that marketing claims surrounding product rendered product a medical device which was adulterated and misbranded.

Code information

All product distributed between November 7, 2017 to September 4, 2019

Distribution pattern

US, Puerto Rico, U.S. Virgin Islands, Canada, Mexico, Australia, PHILIPPINES, Greece, United Kingdom, Israel, Nigeria, Hungary, United Arab Emirates