Mozarc Medical US LLC
Mozarc Medical US LLC has 12 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-2319-2026 · Class II · Apr 29, 2026
- Latest 510(k)
- Aug 6, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 12 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 1 | 0 |
| 2025 | 0 | 0 | 0 | 11 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 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… | Apr 29, 2026 |
| Z-0422-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12… | Oct 17, 2025 |
| Z-0421-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12… | Oct 17, 2025 |
| Z-0426-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety… | Oct 17, 2025 |
| Z-0424-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12… | Oct 17, 2025 |
| Z-0423-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12… | Oct 17, 2025 |
| Z-0425-2026 | Class II | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12… | Oct 17, 2025 |
| Z-1889-2025 | Class II | MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Apr 23, 2025 |
| Z-1888-2025 | Class II | Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Apr 23, 2025 |
| Z-1886-2025 | Class II | Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Apr 23, 2025 |
| Z-1885-2025 | Class II | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Apr 23, 2025 |
| Z-1887-2025 | Class II | Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Apr 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… | Aug 6, 2026 |
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