BD ChloraPrep Hi-Lite Orange Recall Due to Sterility Concerns
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CareFusion 213, LLC is recalling 7,650 units of BD ChloraPrep Hi-Lite Orange applicators distributed nationwide due to lack of assurance of sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
CareFusion 213, LLC initiated a voluntary recall of BD ChloraPrep Hi-Lite Orange applicators after unsterilized products intended for further processing were distributed outside the intended channel, resulting in a lack of assurance of sterility.
Which Products Are Affected
The recall covers BD ChloraPrep Hi-Lite Orange (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, catalog 930415NS; b) 250 x 3mL applicators/case, bulk catalog number 930415NSB. A total of 7,650 units are affected, distributed nationwide in the USA. Specific lots include multiple batch numbers with expiration dates ranging from 06/30/2026 to 04/30/2028. The recalling firm is CareFusion 213, LLC, El Paso, TX. Recall number D-0647-2026.
What You Should Do
Consumers should contact the recalling firm for information on returns or further instructions regarding the affected products.
Why This Matters
The affected applicators are intended for topical use and the sterility issue may compromise product safety for healthcare applications.
Source
FDA recall D-0647-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,226 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.