The Recall Desk

Manufacturer

Mozarc Medical US LLC

12 recalls in our database name Mozarc Medical US LLC as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
0
Most recent
2026-06-17

Of the 12 recalls from Mozarc Medical US LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

  • ModerateFDA (Devices)·Z-2319-2026·2026-06-17

    Mahurkar Elite PASS trays shipped without the labeled Tegaderm CHG dressing

    Mahurkar Elite PASS Trays are being recalled because the Tegaderm CHG dressing specified in the product labeling was missing from certain lots. 25,627 units are affected.

    Product
    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 Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2026·2025-11-12

    Straight extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2026·2025-11-12

    Straight extension catheter trays 24 cm recalled over header bag seals

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions and IC components, 12 Fr x 24 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2026·2025-11-12

    Dialysis catheter trays recalled over seal integrity of header bag packaging

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 16 cm, over a potential issue with the seal integrity of the header bag packaging.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2026·2025-11-12

    Curved extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 13 cm, over a potential issue with the seal integrity of the header bag packaging.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2026·2025-11-12

    Curved extension catheter trays 20 cm recalled over header bag seals

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with curved extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2026·2025-11-12

    Twenty centimetre straight catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2025·2025-06-11

    Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack recalled

    Mozarc Medical is recalling Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. The affected catheter models were distributed nationwide in the US and in Canada and Mexico.

    Product
    Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2025·2025-06-11

    Palindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall

    Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.

    Product
    Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2025·2025-06-11

    Palindrome Precision Chronic Hemodialysis Catheter Sport Pack Recalled

    Mozarc Medical US LLC is recalling Palindrome Precision Chronic Hemodialysis Catheter Sport Pack units due to a potential breach of sterile barrier packaging. Affected units were distributed worldwide including the US, Canada, and Mexico.

    Product
    Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2025·2025-06-11

    MAHURKAR Chronic Hemodialysis Catheter recalled for sterile barrier defect

    Mozarc Medical is recalling MAHURKAR Chronic Hemodialysis Catheter Sport Pack units due to a potential breach in sterile barrier packaging that could compromise the product's sterility.

    Product
    MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2025·2025-06-11

    Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack Recalled

    Mozarc Medical is recalling Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Packs due to a potential breach of sterile barrier packaging that could compromise the catheter's sterility.

    Product
    Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide