Recall Z-3076-2026

Medline Industries, LP · initiated July 20, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F

Codes / lots: CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

Firm began notifying consignees on 7/20/2026 via First-Class Mail and email. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Details

Recall number
Z-3076-2026
Initiated
July 20, 2026
Posted by FDA
August 31, 2026
Product code
MLS – Labor And Delivery Kit
Quantity
222,653 total
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3067-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3068-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3069-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3070-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3071-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3072-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3073-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3074-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3075-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3077-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3078-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3079-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified