# FDA recall Z-0422-2026

> **Mozarc Medical US LLC** · Class II · device recall initiated 2025-10-17.

## Product

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0422-2026
- **Recalling firm:** Mozarc Medical US LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-17
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2026

## Citation

> AI Analytics. FDA recall Z-0422-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0422-2026. Source: US FDA. Licensed CC0.

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