Merit Medical Systems, Inc.: Device Recall
Recall #Z-2296-2025 · 06/05/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2296-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Merit Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 06/05/2025
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 858
Reason for Recall
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.
Product Description
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Distribution Pattern
US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
Other Recalls by Merit Medical Systems, Inc.
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.