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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86380

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

Open FDA event record

Event summary

Timeline bucket
July 21, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA

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

Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

Z-0107-2021
Recall number
Z-0107-2021
Initiated
July 21, 2020
Classification
Class II
Status
Ongoing
Quantity
18,500,000 Masks

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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

Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

Code information

Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01

Distribution pattern

US Nationwide distribution including in the states of CA and OH.