Z-0107-2021Class II

Ezycare Face Mask, Disposable Non Medical Face Masks -

Name: Z-0107-2021 Ezycare Face Mask, Disposable Non Medical Face Masks -
Creator: Beyond White Spa Llc D.b.a. Ezywipe of Amercia
Published: 2020-07-21
License: https://open.fda.gov/license/

Beyond White SpA LLC D.B.A. Ezywipe of Amercia / initiated 2020-07-21 / Open, Classified / root cause: labeling and UDI

FDA source

BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA began a recall of Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control on 2020-07-21. FDA classified it as Class II and gives the reason as "Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0107-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-21
Posted: 2020-10-14
Recalling firm: Beyond White SpA LLC D.B.A. Ezywipe of Amercia
Product: Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Product code: QKR Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
Reason for recall: Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: During conference calls on July 23 and July 24 with customers, we discussed quarantining the masks. The masks have been quarantined since. Ezywipe has agreed that it will quarantine the masks if they are sent back from the customer.
Quantity in commerce: 18,500,000 Masks
Distribution: US Nationwide distribution including in the states of CA and OH.
Product codes and lots: Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0107-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-21	2020-10-14

Product code QKR

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)