Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Jul 20, 2026, 00:00 UTC)

Source: FDA · United States

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.

It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

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 ↗

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Comparable nationwide notices (length or severity timing) 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

Common Questions

What people usually ask about a notice like this one.

What is this FDA recall about?
Medline Industries is recalling 222,653 convenience kits containing BD ChloraPrep Clear 1mL applicators due to potential open or incomplete seals on applicator packaging.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "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." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.