Mozarc Medical US LLC: Medical Device Recall in 2025 - (Recall #: Z-0421-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

Product Classification:

Class II

Date Initiated: October 17, 2025

Date Posted: November 12, 2025

Recall Number: Z-0421-2026

Event ID: 97848

Reason for Recall:

A potential issue with the seal integrity of header bag packaging.

Status: Ongoing

Product Quantity: 3,258 units

Code Information:

REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated