CLASS II ONGOING Device recall · Reported 21 Oct 2020 · FDA Enforcement Report
Ezycare Face Mask, Disposable Non Medical Face Masks recalled
Beyond White Spa Llc D.b.a. Ezywipe Of Amercia is recalling Ezycare Face Mask, Disposable Non Medical Face Masks, distributed nationwide in the US. The recall was initiated on 21 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0107-2021
- FDA event ID
- 86380
- Recalling firm
- Beyond White Spa Llc D.b.a. Ezywipe Of Amercia, Miami, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2020
- FDA classified
- 14 Oct 2020
- Reported
- 21 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 21 Jul 2020 | Recall initiated by company | |
| 14 Oct 2020 | Classified by FDA | +85 days |
| 21 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Product as listed by the FDA
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Where it was distributed
US Nationwide distribution including in the states of CA and OH.
Questions about this recall
Is Ezycare Face Mask, Disposable Non Medical Face Masks recalled?
Yes. Beyond White Spa Llc D.b.a. Ezywipe Of Amercia recalled Ezycare Face Mask, Disposable Non Medical Face Masks on 21 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-0107-2021.
Why was it recalled?
Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.
Which lots are affected?
Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
Where was it sold?
US Nationwide distribution including in the states of CA and OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray Incorporated | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&m Halyard | Other | Nationwide |