Merit Medical Systems, Inc.: Device Recall
Recall #Z-1434-2025 · 01/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1434-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Merit Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 01/27/2025
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
Reason for Recall
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Product Description
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Distribution Pattern
International distribution to the country of Japan.
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.