Medline Convenience Kits Recall Over BD ChloraPrep Clear Applicator Seal Issue (Ref. 597832)
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, LP is recalling 222,653 convenience kits containing specific lots of BD ChloraPrep Clear 1mL Applicators due to potential open or incomplete seals.
What this FDA recall tells you, and what most readers miss
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.
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.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP initiated a voluntary recall of certain Medline Convenience Kits after a downstream recall from the manufacturer of BD ChloraPrep Clear - 1mL Applicators. Affected applicators may have an open or incomplete seal on the packaging.
Which Products Are Affected
The recall covers Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators distributed nationwide. Affected products include:
- BASIN PACK-LF (DYNJ42828B, UDI-DI 10198459425516) with lots 25GBQ173, 25HBB240, 25JBD028, 25LBL133, 26ABU673, 26CBN583, 26EBD855, 26FBO892
- EYE BASIN TRAY-LF (DYNJ42832B, UDI-DI 10198459425530) with lots 25LBE548, 26BBG040, 26CBH272, 26EBC041, 26FBD497 A total of 222,653 units are affected under FDA recall number Z-3069-2026.
What You Should Do
Consumers should check product lots against the listed codes and avoid use of affected items. Contact Medline Industries, LP for further instructions on returns or refunds.
Why This Matters
Use of potentially contaminated applicators may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Source
FDA recall Z-3069-2026, Medline Industries, LP, Northfield, IL. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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
Nationwide notices with similar 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.
Similar body length
Nearest notices by article body length (1,283 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 15, 2026.
Frequently Asked Questions
Questions readers often have about this FDA recall.