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 skin antiseptic applicators were distributed without proper sterilization. These units were intended for further processing and sterilization before use, but were instead sent directly to customers. This creates a risk of infection if the applicators are used as distributed.
- Check if you have ChloraPrep Hi-Lite Orange applicators with the recalled lot numbers listed (3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, or 5084224).
- Do not use recalled applicators intended for direct patient care.
- Contact your supplier or BD customer service for instructions on return or replacement.
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
400 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) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2026More 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 Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD PurPrep povidone-iodine applicators recalled for lack of sterility assurance
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