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 Adult Blood Culture, 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 codesDYNDH1444D UDI-DI 10195327502492 Lots 24IBK133 24KBE072 24LBD419 25GBT189 25IME347 25IMI389 25KMA880 25KME693 26BMH685 26CMH411 26DME199 26EMB070 26EMF542 26FMC275 DYNDH1866 UDI-DI 10195327400958 Lots 24HBW237 24IBI505 24JBI308 24KBH534 24LBI545 25ABC487 25ABO282 DYNDH1462B UDI-DI 10195327662462 Lots 24HBV192 24IBE469 24IBV947 24JBA557 24JBI310 24KBJ830 24KBJ831 24KBN934 24LBN283 24LBP258 DYNDH1622C UDI-DI 10195327509873 Lots 24IBE381 24IBL908 24JBF575 24JBS022 24KBN937 24LBI552 DYNDH1622D UDI-DI 10198459234965 Lots 25GBA905 25GBI398 25GBT182 25HBN203 25IBH345 25IBQ486 25IBS192 25JBN629 25KBK718 25LBI568 DYNDH1622F UDI-DI 10198459658884 Lots 26BBL477 26CBA407 26CBD376 26DBA855 26DBL286 26FBF458 DYNDH1715B UDI-DI 10195327407094 Lot 24IMF148 DYNDH2028 UDI-DI 10198459035715 Lot 24KBL250 DYNDH2048 UDI-DI 10198459106125 Lots 24JBK987 25GBI401 25GBT183 25IBB666 25JBC742 25KBD093 25KBK723 25LBI567 25LBO863 26ABL653 26CBO165 26DBB153 26DBE994 26EBF752 26FBN334 DYNDH2089 UDI-DI 10198459244070 Lots 25KMJ967 26BMI731 26FMF126 DYLAB1081 UDI-DI 10198459199608 Lots 24LMH506 25HMA386 25HMD685 25IMF415 25JMB438 25JMC503 26AML138 26BMJ277 26EMB352 DYLAB1080 UDI-DI 10198459199615 Lots 24LMG085 25AMH560 DYNDH1445C UDI-DI 10195327502614 Lots 24IBK131 24KBB551 24LBU139 25GBQ023 25GBU016 25HMI515 25IMB465 25IME350 25JMI247 26CMB609 26DMH686 26FMC274 26FMC274D DYNDH2350 UDI-DI 10198459779251 Lot 26FBM766 DYNDH2093 UDI-DI 10198459256967 Lot 26ABP408
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-3073-2026
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 ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

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?

DYNDH1444D UDI-DI 10195327502492 Lots 24IBK133 24KBE072 24LBD419 25GBT189 25IME347 25IMI389 25KMA880 25KME693 26BMH685 26CMH411 26DME199 26EMB070 26EMF542 26FMC275 DYNDH1866 UDI-DI 10195327400958 Lots 24HBW237 24IBI505 24JBI308 24KBH534 24LBI545 25ABC487 25ABO282 DYNDH1462B UDI-DI 10195327662462 Lots 24HBV192 24IBE469 24IBV947 24JBA557 24JBI310 24KBJ830 24KBJ831 24KBN934 24LBN283 24LBP258 DYNDH1622C UDI-DI 10195327509873 Lots 24IBE381 24IBL908 24JBF575 24JBS022 24KBN937 24LBI552 DYNDH1622D UDI-DI 10198459234965 Lots 25GBA905 25GBI398 25GBT182 25HBN203 25IBH345 25IBQ486 25IBS192 25JBN629 25KBK718 25LBI568 DYNDH1622F UDI-DI 10198459658884 Lots 26BBL477 26CBA407 26CBD376 26DBA855 26DBL286 26FBF458 DYNDH1715B UDI-DI 10195327407094 Lot 24IMF148 DYNDH2028 UDI-DI 10198459035715 Lot 24KBL250 DYNDH2048 UDI-DI 10198459106125 Lots 24JBK987 25GBI401 25GBT183 25IBB666 25JBC742 25KBD093 25KBK723 25LBI567 25LBO863 26ABL653 26CBO165 26DBB153 26DBE994 26EBF752 26FBN334 DYNDH2089 UDI-DI 10198459244070 Lots 25KMJ967 26BMI731 26FMF126 DYLAB1081 UDI-DI 10198459199608 Lots 24LMH506 25HMA386 25HMD685 25IMF415 25JMB438 25JMC503 26AML138 26BMJ277 26EMB352 DYLAB1080 UDI-DI 10198459199615 Lots 24LMG085 25AMH560 DYNDH1445C UDI-DI 10195327502614 Lots 24IBK131 24KBB551 24LBU139 25GBQ023 25GBU016 25HMI515 25IMB465 25IME350 25JMI247 26CMB609 26DMH686 26FMC274 26FMC274D DYNDH2350 UDI-DI 10198459779251 Lot 26FBM766 DYNDH2093 UDI-DI 10198459256967 Lot 26ABP408

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
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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