Recall Weekly
Moderate riskFDA DeviceClass II

Medline Convenience Kits with BD ChloraPrep applicators recalled for open or incomplete seal

Medline Convenience Kits containing BD ChloraPrep Clear applicators from specific lots may have open or incomplete seals on the applicator packaging. Using a potentially contaminated applicator could lead to skin, soft tissue, or systemic infection.

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

What to do

  1. Check if you have one of the affected kits (DYKS2018, DYKS1584A, DYKS1216I, or DYKM1398B) and verify the lot number matches those listed in the recall.
  2. Do not use applicators with open or damaged packaging.
  3. Contact Medline or your supplier for instructions on return or replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
Sold in
Nationwide
Made for
All ages

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-3074-2026

In the FDA's words

Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B 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. DYKS2018 UDI-DI 10198459188480 Lot 25GMI043 DYKS1584A UDI-DI 10198459146633 Lots 24JBA740 25ABF244 DYKS1216I UDI-DI 10198459362668 Lots 25GBP888 25JBD789 26ABL474 26CBF334 26DBD640 26EBB855 26FBC632 DYKM1398B UDI-DI 10198459413827 Lots 25HBI183 25JBK222 25KBA990 25LBJ990 26BBI525 26CBJ249 26EBQ630 26FMF189 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

More from Medline

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device