The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0107-2021·Announced 2020-10-21

Ezycare Disposable Face Masks Recalled for Mislabeling as Non-Medical

FDA is recalling Ezycare disposable face masks because they were labeled as non-medical but distributed to customers expecting medical use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is mislabeling, which fits the Moderate severity criteria for labeling errors without reported serious injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Ezycare Face Masks, which are disposable non-medical face masks. The product was marketed under a face mask umbrella Emergency Use Authorization (EUA) as source control. The recall is due to the masks being labeled as non-medical while being distributed to customers who expected medical use face masks.

The recalling firm is BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA. The recall involves 18,500,000 masks with manufacturer lot numbers EM20AP01, EM20AP02, EM20AP03, and EM20MA01. Distribution was nationwide in the United States, including in the states of California and Ohio.

Consumers who have purchased these masks should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Manufacturer
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
Category
Medical Device — Face Masks
Hazard
Affected units
18,500,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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