BD ChloraPrep Scrub Teal Recall Issued for Sterility Concerns

Source: FDA · United States

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 125 units of BD ChloraPrep Scrub Teal 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 after unsterilized ChloraPrep 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

The recall covers BD ChloraPrep Scrub Teal (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as:

  • 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS
  • 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB

Affected lots include:

  • Lot 3352149 (Exp 12/31/2026)
  • Lot 5028798 (Exp 01/31/2028)
  • Lot 5069651 (Exp 03/31/2028)

A total of 125 units were distributed nationwide in the USA. The recall number is D-0650-2026 and it is classified as Class II.

What You Should Do

Consumers should follow guidance from the recalling firm, CareFusion 213, LLC, regarding the affected products.

Why This Matters

This Class II recall addresses a sterility assurance issue with topical antiseptic applicators distributed across the United States.

Source

FDA recall D-0650-2026, initiated June 11, 2026.

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
CareFusion 213, LLC is recalling 125 units of BD ChloraPrep Scrub Teal applicators distributed nationwide due to lack of assurance of sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.