OFFICIAL-SOURCE RECALL · AUSTRALIA
POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer & Recall: Classification Class II Reason for the
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
- POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer & Divider
- Manufacturer
- See official notice
- Lot number
- numbers, FR490902, number
- Batch number
- numbers
- Model number
- PS-0523CJDA
- 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 II Reason for the Action Lot FR490902 may contain a labelling discrepancy. Specifically, the affected units were packaged in an outer shelf box labelled for a 37cm device versus an outer shelf box labelled for a 23cm device. However, other labelling on the outer shelf box, as well as the device and product cord label correctly identify the product as the 23cm device, which may result in customer confusion, a delay in initiating treatment, or prolongation of a procedure. All devices contained within Lot FR490902 are the correct 23cm length. Instructions for Customers/Users Customers are to: 1) Review inventory for the affected lot number. Discard the outer box and attach the customer letter to the inner device packaging. 2) Continue to use the device per the IFU. 3) Check the sterile packaging and device labels before use to ensure they are using the correct length for their procedure. Action Commencement Date 11/08/2026 Responsible Entity Olympus Australia Pty Ltd
Hazard
Classification Class II Reason for the Action Lot FR490902 may contain a labelling discrepancy. Specifically, the affected units were packaged in an outer shelf box labelled for a 37cm device versus an outer shelf box labelled for a 23cm device. However, other labelling on the outer shelf box, as well as the device and product cord label correctly identify the product as the 23cm device, which may result in customer confusion, a delay in initiating treatment, or prolongation of a procedure. All devices contained within Lot FR490902 are the correct 23cm length. Instructions for Customers/Users Customers are to: 1) Review inventory for the affected lot number. Discard the outer box and attach the customer letter to the inner device packaging. 2) Continue to use the device per the IFU. 3) Check the sterile packaging and device labels before use to ensure they are using the correct length for their procedure. Action Commencement Date 11/08/2026 Responsible Entity Olympus Australia Pty Ltd
Official recall notice
POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer & Divider
Agency: Therapeutic Goods Administration
Official publication date: August 11, 2026
Read the official AU_TGA_DRAC recall notice →Scan products you own
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