Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No

Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

On 08/20/2026, an "URGENT: MEDICAL DEVICE CORRECTION" Letter was emailed to customer informing them of an updated Instruction for Use (IFU) to address two Hemospray potential issues: endoscope adhesion and inability to spray powder. Customers are instructed to: 1. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have subject product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 2. This notice must be shared with appropriate personnel, down to the user level, within your organization or with any organization where the subject devices have been transferred. 3. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. access the video showing recommended mitigation techniques for endoscope adherence. Alternatively, follow this link: https://players.brightcove.net/309212793001/default_default/index.html?videoId=6399387869112 and access the Instructions for Use video showing appropriate steps for Hemospray use. Alternatively, follow this link: https://players.brightcove.net/309212793001/default_default/index.html?videoId=6363265645112 For question or further assistance - contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235 or your local Cook representative.