ETHEREA-MX® System recall in Canada: labelling and packaging issues
In plain language
This recall involves the ETHEREA-MX® System, IPL Filter 540nm, and ER:YAG DualMode® Laser Handpiece 2940nm sold in Canada. It's being recalled because of incorrect user manuals and indications not approved by Health Canada. This recall is for healthcare professionals. Contact the manufacturer for more information.
What to do
- Contact the manufacturer, Vydence Medical - Indústria e Comércio Ltda., for additional information.
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Affected products
IPL Filter 540nm
Model: 011284
Lot: All lots
ER:YAG DualMode® Laser Handpiece 2940nm
Model: 018091
Lot: All lots
ETHEREA-MX® System
Model: 018058
Lot: All lots
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 011284, 018058, 018091
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves the ETHEREA-MX® System, IPL Filter 540nm, and ER:YAG DualMode® Laser Handpiece 2940nm sold in Canada. It's being recalled because of incorrect user manuals and indications not approved by Health Canada. This recall is for healthcare professionals. Contact the manufacturer for more information.
What should consumers do?
Contact the manufacturer, Vydence Medical - Indústria e Comércio Ltda., for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on October 31, 2023.
Is the Vydence Medical - Indústria e Comércio Ltda. brand affected by this recall?
Yes, Vydence Medical - Indústria e Comércio Ltda. products are affected by this recall. This recall involves the ETHEREA-MX® System, IPL Filter 540nm, and ER:YAG DualMode® Laser Handpiece 2940nm sold in Canada. It's being recalled because of incorrect user manuals and indications not approved by Health Canada. This recall is for healthcare professionals. Contact the manufacturer for more information.