Class 2 Device Recall Medline

• Date Initiated by Firm: July 20, 2026
• Date Posted: August 31, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3073-2026
• Recall Event ID: 99561
• Product Classification: Blood and urine collection kit (excludes HIV testing) - Product Code OIB
• Product: 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
• Code Information: 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
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-633-5463
• Manufacturer 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: 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.
• Quantity in Commerce: 222,653 total
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.