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Mozarc Medical US LLC FDA Recalls
12 recalls on file across devices, 0 of them Class I and 12 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight ExteClass IIApr 29, 2026The Tegaderm CHG dressing, as specified in product labeling, |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cmClass IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mmClass IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 Class IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cmClass IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 Class IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cmClass IIOct 17, 2025A potential issue with the seal integrity of header bag pack |
| Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Class IIApr 23, 2025Potential breach of sterile barrier packaging. |
| Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Class IIApr 23, 2025Potential breach of sterile barrier packaging. |
| Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Class IIApr 23, 2025Potential breach of sterile barrier packaging. |
| Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Class IIApr 23, 2025Potential breach of sterile barrier packaging. |
| MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Class IIApr 23, 2025Potential breach of sterile barrier packaging. |