BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
What this means
BD ChloraPrep Hi-Lite Orange applicators intended for further sterilization before use were mistakenly distributed directly to customers without undergoing the required sterilization process. These applicators are used to prepare skin before medical procedures and must be sterile to be safe. The recall affects specific lot numbers distributed nationwide.
- Check if you have BD ChloraPrep Hi-Lite Orange applicators with the recalled lot numbers listed in the FDA notice.
- Do not use applicators from recalled lots. Contact your supplier or BD for replacement sterile units.
- If you used applicators from a recalled lot on patients, consult your facility's infection control protocol and consider notifying affected patients per your institutional guidelines.
The agency's original wording
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2026More CareFusion recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD PurPrep povidone-iodine applicators recalled for lack of sterility assurance
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