Preime Dermafacial
Brand(s)
Last updated
Summary
Product
Preime Dermafacial
Issue
Medical devices - Unauthorised device
What to do
Cease use of device until Medical Device License (MDL) is issued.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Preime Dermafacial | Not applicable. | 4001 |
Issue
The Preime Dermafacial is being recalled as they were incorrectly sold as electronic devices but should have been classified as Class II/Class III devices, and thus do not have a valid Medical Device License (MDL). There is no defect to the products.
Recall start date: June 30, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
| Ema Aesthetics Ltd. |
| Palmerston House Fenian Street, Dublin, Dublin, Ireland, D02 WD37 |
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-77757
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