Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Jul 20, 2026, 00:00 UTC)
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries is recalling 222,653 convenience kits containing BD ChloraPrep Clear 1mL applicators due to potential open or incomplete seals on applicator packaging.
FDA recall: what the record actually shows
This notice was issued by FDA on September 16, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed us nationwide distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
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What Happened
Medline Industries, LP initiated a voluntary recall of certain convenience kits after a downstream recall of specific lots of BD ChloraPrep Clear - 1mL Applicators. The affected applicators may exhibit an open or incomplete seal on the packaging.
Which Products Are Affected
The recall covers Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators, including LABOR CDS (CDS981762B, UDI-DI 10193489306767, lots 24JBE456, 24JBN932, 24KBJ154, 25ABK513, 25CBL684, 25HBK086, 25IBM188, 25KBL720, 25LBF812, 25LBU497, 26ABM665, 26CBH544, 26CBT272, 26FBK806) and VAG DELIVERY ADMISSION BAG (DYKA1054F, UDI-DI 10193489312607, lots 24ILA823, 24JLA285, 24LLA226, 24LLB033, 25BLA842, 25ELA624, 25GLA270, 25HLB055, 25KLA019, 25KLA187, 26BLA150, 26CLA717, 26DLA410, 26ELA772, 26FLA756). A total of 222,653 units are affected under recall number Z-3076-2026. The products were distributed nationwide in the United States.
What You Should Do
Use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. Customers should follow guidance from the recalling firm regarding the affected lots.
Why This Matters
The Class II recall addresses a defect that could result in infection risks from compromised sterile packaging on the included applicators.
Source
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (Recall Number Z-3076-2026, Event ID 99561, Medline Industries, LP)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Medline Convenience Kits Recall Over ChloraPrep Applicator Sterility Breach (Ref. 2fe0d4)
FDA · September 16, 2026
Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 1adab6)
FDA · September 16, 2026
Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)
FDA · September 16, 2026
Comparable nationwide notices (length or severity timing) 8
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