BD ChloraPrep Hi-Lite Orange Recall
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 appli
Updated June 11, 2026
BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic) were distributed without proper sterilization assurance. These products should have been sterilized before use but were sent directly to customers instead, creating a risk of infection.
Is the CareFusion 213, LLC recalled? Yes. This product was recalled by FDA on June 11, 2026. Details below.
What is recalled
BD ChloraPrep Hi-Lite Orange (2% chlorhexidine gluconate and 70% isopropyl alcohol) in 10.5 mL applicators: 100-count cases with NDC 54365-400-35 and Catalog Number 930715NS, or bulk Catalog Number 930715NSB. Manufactured by CareFusion 213, LLC in El Paso, TX.
Am I affected
You're affected if you have BD ChloraPrep Hi-Lite Orange 10.5 mL applicators (100-count cases) with NDC 54365-400-35, Catalog Number 930715NS, or bulk Catalog Number 930715NSB.
What to do right now
Stop using these applicators immediately. Contact your supplier or CareFusion 213, LLC (a subsidiary of Becton, Dickinson and Co.) for instructions on return or replacement of sterilized product.
The 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
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0643-2026
- Classification
- Class II
- Recalled
- June 11, 2026
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