# FDA recall Z-1440-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-02-11.

## Product

Medline procedure kits labeled as:    1) CT BIOPSY PACK, Pack Number DYNJ62734A;   2) E R C P PACK, Pack Number DYNJ44115A;  3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1440-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-11
- **Report date:** 2025-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2025

## Citation

> AI Analytics. FDA recall Z-1440-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1440-2025. Source: US FDA. Licensed CC0.

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