# FDA recall Z-0359-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-10-23.

## Product

URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

## Reason for recall

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

## Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.

## Key facts

- **Recall number:** Z-0359-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-23
- **Report date:** 2024-11-20

- **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-0359-2025

## Citation

> AI Analytics. FDA recall Z-0359-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0359-2025. Source: US FDA. Licensed CC0.

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