Medline Convenience Kits with BD ChloraPrep applicators recalled for potential seal failure and infection risk
What this means
BD ChloraPrep Clear applicators in certain Medline pre-op convenience kits may have open or incomplete seals on their packaging. If a sealed applicator is compromised, it could become contaminated and cause a skin, soft tissue, or systemic infection when used.
- Check if you have one of the affected pre-op kits (DYKS2018, DYKS1584A, DYKS1216I, or DYKM1398B).
- Do not use the ChloraPrep applicators if the package seal appears open, incomplete, or damaged.
- Contact Medline or your supplier for instructions on replacement or disposal.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3074-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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