FDA-Drug2026-07-08Class IIPROCESSING DEFECT
BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
What this means
BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic used before medical procedures) were distributed without proper sterilization. These applicators were intended to be sterilized before use, but some unsterilized units were sent to customers outside the normal supply chain.
- Check your ChloraPrep Hi-Lite Orange applicators against the lot numbers listed (3362296, 4066870, 4104107, 4276125, 4080695, or 4233300).
- Do not use unsterilized applicators on patients or for medical procedures.
- Contact CareFusion or your supplier immediately if you have affected lots.
- Report any patient injuries or infections to your healthcare provider or the FDA.
The agency's original wording
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
1,800 units
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0643-2026More 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 ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
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