Wilson-Cook Medical Inc. recalls Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT…

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 (FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com. 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.

• FDA enforcement recordOfficial FDA database entry for Z-3177-2026
• FDA 510(k) clearance · K253302The device's official FDA premarket clearance record
• FDA device classification · QAUOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4456The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Wilson-Cook Medical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.