BD ChloraPrep Hi-Lite Orange Recall Due to Sterility Issues
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CareFusion 213, LLC is recalling 1,800 units of BD ChloraPrep Hi-Lite Orange applicators 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 certain 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 (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. Affected lots include a) 3362296 (exp. 12/31/2026), 4066870 (exp. 02/28/2027), 4104107 (exp. 03/31/2027), 4276125 (exp. 09/30/2027); b) 4080695 (exp. 03/31/2027), 4233300 (exp. 08/31/2027). A total of 1,800 units were distributed nationwide in the USA.
What You Should Do
Consumers in possession of the affected products should not use them. Contact the recalling firm for further instructions regarding the recall.
Why This Matters
The recall involves a topical antiseptic solution distributed for use in healthcare settings across the United States, classified as Class II by the FDA.
Source
FDA recall number D-0643-2026. Data from FDA enforcement report.
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 (1,254 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.