OFFICIAL-SOURCE RECALL · AUSTRALIA
Renuvion APR Handpiece Recall: Classification Class III Reason for the Action Apyx
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Renuvion APR Handpiece
- Manufacturer
- See official notice
- Lot number
- numbers
- Batch number
- numbers
- Date code
- dates
- Expiration date
- dates
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class III Reason for the Action Apyx Medical has updated the labeling for the Renuvion APR Handpieces to align with an update to the intended purpose statement in the Australian Register of Therapeutic Goods (ARTG). To ensure devices supplied to the Australian market are in compliance with the Essential Principles, new Instructions for Use (IFU) MC-15-451-005A have been created for the Renuvion APR Handpieces. Instructions for Customers/Users Customers are to: - Review the updated IFU at https://eifu.apyxmedical.com/ - Discard any printed IFUs packaged with the device. Action Commencement Date 20/08/2026 Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Hazard
Classification Class III Reason for the Action Apyx Medical has updated the labeling for the Renuvion APR Handpieces to align with an update to the intended purpose statement in the Australian Register of Therapeutic Goods (ARTG). To ensure devices supplied to the Australian market are in compliance with the Essential Principles, new Instructions for Use (IFU) MC-15-451-005A have been created for the Renuvion APR Handpieces. Instructions for Customers/Users Customers are to: - Review the updated IFU at https://eifu.apyxmedical.com/ - Discard any printed IFUs packaged with the device. Action Commencement Date 20/08/2026 Responsible Entity Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Official recall notice
Renuvion APR Handpiece
Agency: Therapeutic Goods Administration
Official publication date: August 20, 2026
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