CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

Medline Convenience Kits containing BD ChloraPrep Clear recalled

Medline Industries is recalling Medline Convenience Kits containing BD ChloraPrep Clear - Applicators Patient Admin Kit, distributed nationwide in the US. The recall was initiated on 20 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733
Quantity recalled222,653 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-3075-2026
FDA event ID
99561
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
20 Jul 2026
FDA classified
31 Aug 2026
Reported
9 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

20 Jul 2026Recall initiated by company
31 Aug 2026Classified by FDA+42 days
9 Sep 2026Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 99561

This product is part of a recall event; the main page for the event is Medline Convenience Kits containing BD ChloraPrep Clear recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep-LF DYNJ42832B recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep DYKA1054F recalledMedline IndustriesPackaging DefectsNationwide
CLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide

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