Mozarc Medical US LLC
FDA Regulatory Profile
Mozarc Medical US LLC appears in FDA public data with 12 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2319-2026, Class II) was initiated on April 29, 2026. Its most recent 510(k) clearance was granted on August 6, 2026.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2319-2026 | Class II | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Cathete | April 29, 2026 |
| Z-0421-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr | October 17, 2025 |
| Z-0425-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 | October 17, 2025 |
| Z-0422-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr | October 17, 2025 |
| Z-0423-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr | October 17, 2025 |
| Z-0424-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 | October 17, 2025 |
| Z-0426-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Componen | October 17, 2025 |
| Z-1888-2025 | Class II | Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | April 23, 2025 |
| Z-1889-2025 | Class II | MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | April 23, 2025 |
| Z-1886-2025 | Class II | Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | April 23, 2025 |
| Z-1887-2025 | Class II | Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | April 23, 2025 |
| Z-1885-2025 | Class II | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | April 23, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Ca | August 6, 2026 |