OFFICIAL-SOURCE RECALL · AUSTRALIA
Hemospray Endoscopic Hemostat Recall: Classification Class II Reason for the Action Cook
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- Brand
- See official notice
- Product
- Hemospray Endoscopic Hemostat
- Manufacturer
- See official notice
- Lot number
- numbers, 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 II Reason for the Action Cook Medical is updating the Hemospray Instructions for Use (IFU) to include new guidance to address two Hemospray potential problems: 1. Endoscope adhesion and 2. Inability to spray powder. Cook Medical is not removing devices from the field. Instructions for Customers/Users Customers should; 1. Read the customer letter carefully and complete the Customer Response Form. 2. Share this notice with appropriate personnel, including down to the user level, within their organisation or with any organisation where the potentially
Hazard
Classification Class II Reason for the Action Cook Medical is updating the Hemospray Instructions for Use (IFU) to include new guidance to address two Hemospray potential problems: 1. Endoscope adhesion and 2. Inability to spray powder. Cook Medical is not removing devices from the field. Instructions for Customers/Users Customers should; 1. Read the customer letter carefully and complete the Customer Response Form. 2. Share this notice with appropriate personnel, including down to the user level, within their organisation or with any organisation where the potentially
Official recall notice
Hemospray Endoscopic Hemostat
Agency: Therapeutic Goods Administration
Official publication date: August 14, 2026
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