Mozarc Medical US LLC: Device Recall
Recall #Z-0421-2026 · 10/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0421-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Mozarc Medical US LLC
- Status
- Ongoing
- Date Initiated
- 10/17/2025
- Location
- Mansfield, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,258 units
Reason for Recall
A potential issue with the seal integrity of header bag packaging.
Product Description
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Distribution Pattern
US Nationwide distribution.
Other Recalls by Mozarc Medical US LLC
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
- Class II: Risk 10/17/2025
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.