Merit Medical Systems, Inc. recalls Custom Waste Management Kit: REF: K10-00353K

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to response@merit.com If you have questions, contact the firm's customer service at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri

• FDA enforcement recordOfficial FDA database entry for Z-2296-2025
• FDA device classification · PPDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5130The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Merit Medical Systems, 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.