# FDA recall Z-3058-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-06-12.

## Product

Medline Convenience Kits:  1) PRE-OP KIT, Catalog Number: DYKS1043F;   2) PRE OP KIT, Catalog Number: DYKS1128C;   3) PRE OP KIT, Catalog Number: DYKS1216I;   4) PRE OP KIT, Catalog Number: DYKS1325A;   5) CATARACT PREOP KIT, Catalog Number: DYKS1583;   6) GENERAL PREOP KIT, Catalog Number: DYKS1584;   7) GENERAL PREOP KIT, Catalog Number: DYKS1584A;   8) GENERAL PREOP KIT, Catalog Number: DYKS1584B

## Reason for recall

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3058-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-12
- **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-3058-2026

## Citation

> MORVS. FDA recall Z-3058-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3058-2026. Source: US FDA. Licensed CC0.

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