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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmJuly 20, 2026
Date PostedAugust 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3070-2026
Recall Event ID 99561
510(K)NumberK213481 
Product Classification General surgery tray - Product Code LRO
ProductMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520
Code Information DYNDV1875 UDI-DI 10888277860209 Lot 24JMB689 ACC010972 UDI-DI 10198459303289 Lots 25DDA151 25DDA401 25EDA655 ACC010479A UDI-DI 10195327131517 Lot 25BDB620 ACC010690 UDI-DI 10195327433307 Lots 24LDB023 25BDA230 25GDA245 25JDB903 25KDB182 25LDA088 25LDA809 26ADC073 26CDA991 26DDB182 26EDA950 26EDB485 26FDB456 ACC010875 UDI-DI 10198459113659 Lots 24JDA648 25CDB776 25JDB205 25KDB028 25LDB271 26DDA182 26DDA786 26EDA629 ACC011073 UDI-DI 10198459569333 Lot 25LDA072 ACC011088 UDI-DI 10198459589577 Lots 26BDA548 26GDA090 ACC011067 UDI-DI 10198459529184 Lots 25KDA639 25LDA980 26CDB158 DYKM1564 UDI-DI 10889942754571 Lots 24HBW937 24JBX634 24LBR085 25GBH209 25IBK590 25LBD525 26ABI524 26BBM585 26DBC555 DYKM1564A UDI-DI 10198459805165 Lot 26FBK649 DYNJT10325 UDI-DI 10198459787324 Lots 26EBM250 26FBA470 26FBF055 26FBH553 26FBH554 DYKS1089B UDI-DI 10193489306286 Lots 24JMG846 24LMD918 25GMD759 25GMK431 25IMF050 25KMJ026 26BMC073 26DMI048 DYNJ63410 UDI-DI 10193489737431 Lots 24LDB851 25BDA890 DYNDH1363 UDI-DI 10888277795464 Lots 24IBH349 24IBS200 24JBQ160 24KBN447 24LBG380 24LBI547 25ABW563 25DBH954 25GBD824 25HBT172 25IBO192 25JBB921 25JBQ987 ACC010770 UDI-DI 10195327576998 Lots 25HDA878 25IDA087 25IDA817 25JDB317 25KDB340 25LDB061 26ADA012 26ADA159 26ADB380 26ADC072 26BDA633 26CDA678 DYNDH1591 UDI-DI 10193489497236 Lots 24JMA966 25GMD752 25LMJ154 26AME497 26BMA252 26DMI088 26EMH914 26FMH453 26FMK588 EDUC1043 UDI-DI 10195327425531 Lots 24KDA258 24KDA880 24KDA963 EDUC1043A UDI-DI 10198459334559 Lots 25FLA817 25GLA090 25KLA077 25KLA693 26CLB165 26CLB165Z 26ELA472 DYKM1496 UDI-DI 10889942636082 Lot 24KBL243 DYNDV2520 UDI-DI 10653160384045 Lot 2024111990
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley 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 2		Nonconforming Material/Component
ActionFirm 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 Commerce222,653 total
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = LRO
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