Medline Convenience Kits Recall Over BD ChloraPrep Clear Applicator Seal Issue (Ref. 33fe43)
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Medline Industries is recalling 222,653 convenience kits containing specific lots of BD ChloraPrep Clear 1mL applicators due to potential packaging seal defects.
FDA recall: what the record actually shows
This notice was issued by FDA on September 15, 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.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
The original agency source is linked below so you can verify this record directly before acting on it. 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 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, C-SECTION PREP, DYNJ32702B. Affected lots are 25BBB005, 25GBY063, 25KBI862, 25LBT688, and 26CBG211. The UDI-DI is 10193489431070. A total of 222,653 units were distributed nationwide in the United States.
What You Should Do
Consumers should verify lot numbers on affected products. No additional consumer instructions are provided in the recall notice.
Why This Matters
Use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. This is a Class II recall.
Source
FDA recall number Z-3077-2026, event ID 99561.
Original source: FDA Official Notice ↗
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Similar notices nationwide by length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (982 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.