Food, drugs, devices › Mozarc Medical US LLC
Device recall: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm
FDA enforcement event 97848 is a device recall by Mozarc Medical US LLC of Mansfield, MA, initiated 17 Oct 2025 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Mozarc Medical US LLC has 3 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mozarc Medical US LLC, Mansfield, MA.
Reason for recall
"A potential issue with the seal integrity of header bag packaging."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0421-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0422-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0423-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0424-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0425-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0426-2026 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm; | 3,258 units | Class II | Ongoing | 12 Nov 2025 |
Context
Other enforcement events for Mozarc Medical US LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Apr 2026 | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extens | Device | Class II | 1 |
| 23 Apr 2025 | Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. | Device | Class II | 5 |
All 3 events for Mozarc Medical US LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A potential issue with the seal integrity of header bag packaging."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.