# FDA recall Z-3078-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-07-20.

## Product

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators    CATARACT PREOP KIT	  	DYKS1583A

## Reason for recall

Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3078-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-20
- **Report date:** 2026-09-09

- **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-3078-2026

## Citation

> MORVS. FDA recall Z-3078-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3078-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*