BD PurPrep Applicators Recalled for Sterility Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
CareFusion 213, LLC is recalling one lot of BD PurPrep antiseptic applicators due to lack of assurance of sterility after unsterilized units were distributed.
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 because unsterilized ChloraPrep & PurPrep Applicators intended for further processing and sterilization were distributed outside the intended channel, resulting in a lack of assurance of sterility.
Which Products Are Affected
BD PurPrep (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION. Catalog Number 960120NSB; NDC 54365-014-42. Lot: 4298581, expires: 09/30/2026. Distributed Nationwide in the USA. Recall number D-0644-2026. Class II recall.
What You Should Do
Consumers should not use the affected product and should contact the recalling firm for return or further instructions.
Why This Matters
The recall affects a sterile antiseptic solution distributed nationwide, raising concerns about potential contamination in a product intended for topical use.
Source
FDA recall D-0644-2026, report date 20260708. 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 (1,044 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.