# FDA recall Z-1594-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-03-03.

## Product

Medline Convenience kits used for various procedures:  1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A;   2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B;   3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303;   4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B;   5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B;   6) PHLEBECTOMY PACK, Model Number: DYNJ55215G;   7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D;   8) CAT BIOPSY PACK, Model Number: DYNJ62968;   9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D;   10) BIOPSY KIT, Model Number: DYNJ61130B

## Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

## Key facts

- **Recall number:** Z-1594-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-23

- **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-1594-2025

## Citation

> AI Analytics. FDA recall Z-1594-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1594-2025. Source: US FDA. Licensed CC0.

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