FDA Medical Device Recalls (openFDA)
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA: Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
- Recall number
- Z-0107-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2020-07-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
- 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
- 18,500,000 Masks
- Distribution
- US Nationwide distribution including in the states of CA and OH.
- Lot, serial or model codes
- Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKR
- Firm FEI
- 3016691009
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28