Merit Medical Systems, Inc.: Device Recall

Recall #Z-3191-2024 · 08/12/2024

Class II: Risk

Recall Details

Recall Number: Z-3191-2024
Classification: Class II
Product Type: Device
Recalling Firm: Merit Medical Systems, Inc.
Status: Ongoing
Date Initiated: 08/12/2024
Location: South Jordan, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24

Reason for Recall

7F sheath introducers labeled as 7.5F

Product Description

Custom Procedure Kit, REF: K12T-11077

Distribution Pattern

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Other Recalls by Merit Medical Systems, Inc.

Class II: Risk 12/04/2025

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025

Inflation device handle may detach from the syringe during procedure.
Class II: Risk 12/04/2025

Inflation device handle may detach from the syringe during procedure.

View all recalls by Merit Medical Systems, Inc. →

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.