BD ChloraPrep Clear Recall Due to Sterility Concerns
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CareFusion 213, LLC is voluntarily recalling specific lots of BD ChloraPrep Clear 1 mL applicators nationwide due to potential lack of sterility from wrinkles in the paper lidding.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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 Clear applicators due to lack of assurance of sterility caused by wrinkles in the paper lidding which may breach the seal area.
Which Products Are Affected
The recall covers BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1 mL Applicator, 60 Applicators, Sterile Solution, NDC 54365-400-31. Affected lots include: 3201277 (Exp 06/30/2026); 3213912, 3214206, 3214914, 3215710, 3227485 (Exp 07/31/2026); 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318 (Exp 08/31/2026); 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956 (Exp 09/30/2026); 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562 (Exp 10/31/2026); 3321426 (Exp 11/30/2026); 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168 (Exp 12/31/2026); 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559 (Exp 1/31/2027); 4049128, 4060484, 4061622, 4062534 (Exp 02/28/2027); 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351 (Exp 03/31/2027); 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749 (Exp 04/30/2027); 4137704, 4139447 (Exp 05/31/2027). Distribution is nationwide in the USA and foreign markets. This is FDA recall number D-0622-2026, Class II.
What You Should Do
Consumers should verify lot numbers against the recalled list and contact the recalling firm for further instructions.
Why This Matters
The recall addresses a potential sterility issue with a topical antiseptic product distributed widely across the United States.
Source
FDA recall D-0622-2026, CareFusion 213, LLC.
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 (1,744 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.