Moderate riskFDA DeviceClass II

Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for packaging seal defect

Medline Convenience Kits (model DYKS1583A) contain BD ChloraPrep Clear applicators from specific lots with open or incomplete seals on the packaging. A sealed applicator that has been compromised may allow contamination, which could lead to infection if used during surgery.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Check if you have lot 24KBP388 of the Medline Cataract Preop Kit (DYKS1583A).
  2. Do not use applicators with visibly damaged or open packaging.
  3. Contact Medline or your supplier for instructions on replacement or return.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
Sold in
Nationwide
Made for
Adults

This recall covers 13 products — see all of them.

Details

Units affected
222,653 total
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class II
Recall number
Z-3078-2026

In the FDA's words

Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. DYKS1583A UDI-DI 10198459146640 Lot 24KBP388 Distribution: US Nationwide distribution. Affected quantity: 222,653 total
Hazard
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

13 products in this recall

Medline convenience kits recalled for ChloraPrep applicator seal defect

Medline is recalling 13 convenience kits that contain BD ChloraPrep Clear 1mL applicators from specific lots. The applicator packaging may have an open or incomplete seal, so the applicator could be contaminated. Contaminated applicators can cause skin or soft tissue infections, or more serious infections, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

Updates since first reported

  • Oct 6, 2026Hazard description updated

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