Mansfield, MA, United States
Mozarc Medical US LLC recalls
3 recalls recorded since 2018, most recently on 29 April 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 April 2026
- Reason
- The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2319-2026
- Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS
Ongoing Class II Medical devices
- Recall started
- 17 October 2025
- Reason
- A potential issue with the seal integrity of header bag packaging.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0423-2026, Z-0424-2026, Z-0421-2026, Z-0422-2026, Z-0425-2026, Z-0426-2026
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Ongoing Class II Medical devices
- Recall started
- 23 April 2025
- Reason
- Potential breach of sterile barrier packaging.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada & Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1885-2025, Z-1886-2025, Z-1887-2025, Z-1889-2025, Z-1888-2025
- Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.