BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) Recall: What To Do

The carefusion bd recall involves BD ChloraPrep Clear antiseptic applicators made by CareFusion 213, LLC. The U.S. Food and Drug Administration assigned it recall number D-0624-2026 on July 1, 2026. The product failed sterility testing. Regulators found the mold Aspergillus penicillioides. The FDA classified this as a Class I recall. That is the agency’s most serious category. It covers 193,440 units. If you work in healthcare or had a recent procedure, this matters to you.

What the Carefusion Bd Recall Covers

The carefusion bd recall covers one specific antiseptic product. It is BD ChloraPrep Clear. The formula contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA). The recalled configuration is the 1 mL Applicator. These ship 60 applicators per inner carton. The label lists it as a sterile solution. The National Drug Code is NDC 54365-400-31.

The recalling firm is CareFusion 213, LLC of El Paso, TX 79912. That company is a subsidiary of Beckton, Dickinson and Co. Many people know the parent company simply as BD. That is why this action is often called the carefusion bd recall. However, the FDA record names CareFusion 213, LLC as the responsible firm.

ChloraPrep applicators are a common skin-prep product. Typically, clinicians use them before injections, IV starts, and surgery. The single-use applicator swabs the skin to reduce germs before a needle or blade breaks the surface. For example, a nurse may use one before placing a catheter. As a result, the product is stocked in hospitals, clinics, surgery centers, and some home-care settings.

The FDA record does not list retail store names for this action. It also does not publish a lot-by-lot table in the summary entry. The agency does list the scope: 193,440 units. If you need lot numbers or distribution details, check the official notice linked on this page. That notice is the controlling document for the carefusion bd recall.

The Hazard and Reported Injuries

The hazard in this carefusion bd recall is non-sterility. The FDA record states the reason plainly. It is due to the presence of Aspergillus penicillioides. That is a mold. A product labeled sterile is supposed to be free of living organisms. This one was not.

Why does that matter? A skin-prep applicator is used right before the skin barrier is broken. In most cases, that means a needle, an IV line, or a surgical incision follows within seconds. A contaminated applicator can therefore introduce organisms directly into tissue or the bloodstream. That is the opposite of what an antiseptic is meant to do.

Fungal exposure is a particular concern for people with weakened immune systems. For example, patients on chemotherapy, transplant recipients, and critically ill patients face higher risk from mold. Typically, healthy people clear such exposures. However, the FDA’s Class I designation signals that the agency judged the risk serious. Class I means there is a reasonable probability of serious harm or death.

Important: the agency record does not state whether any injuries have been reported in connection with this recall. This article makes no claim either way. Do not assume harm occurred. Also do not assume no harm occurred. The absence of a statement in the record is not evidence in either direction.

What To Do If You Own This Product

Stop using the product first. That is the safest immediate step. Set aside any BD ChloraPrep Clear 1 mL Applicators in your inventory. Do not use them on patients. Do not use them on yourself. Separate them from usable stock so nobody grabs one by mistake.

Next, identify what you have. Check the carton for the product name “BD ChloraPrep Clear.” Confirm the strength: 2% chlorhexidine gluconate and 70% isopropyl alcohol. Confirm the size: 1 mL Applicator. Check the inner carton count of 60 applicators. Then check the NDC. It should read 54365-400-31. Note any lot number printed on the packaging before you set it aside.

For the remedy, follow the instructions in the official notice linked on this page. This article does not state what the remedy is. The agency remedy text in the public record did not match this product, so we have withheld it rather than guess. The official FDA notice is the correct source. Read it before you return, destroy, or discard anything.

Facilities should also notify their own chain. Typically, that means alerting purchasing, pharmacy, infection prevention, and any satellite clinics. For example, a surgery center may have applicators stored in more than one supply room. As a result, a single sweep of the main stockroom is often not enough. Check every location. Home users should contact their prescribing clinician or supplier with questions about the carefusion bd recall.

If you believe you were exposed and feel unwell, talk to a doctor. Do not self-diagnose a fungal infection. However, do mention the exposure so your clinician has the full picture. Keep the packaging, the lot number, and any receipts or purchase records. Documentation is easier to save now than to reconstruct later.

Does a Carefusion Bd Recall Mean You Can Sue?

No. A recall is not a lawsuit. That distinction matters, so it is worth stating plainly. A recall is a safety action. A company, sometimes with agency involvement, pulls a product from the market to prevent harm. The carefusion bd recall is that kind of action. It is a correction, not a court case.

A recall by itself is also not a legal claim. Owning a recalled product does not create a right to money. In most cases, a personal injury claim requires more. Typically, it requires an actual injury. It also requires causation, meaning a link between the product and that injury. It requires proof, not assumption.

However, a recall can matter in a case that already has those elements. If someone was genuinely injured, a Class I recall can be relevant background. It may help show that a defect existed. It may help show when the company learned of the problem. As a result, plaintiffs’ attorneys often review recall records early.

If you think you were harmed, talk to a licensed attorney in your state. An attorney can evaluate the facts, the timeline, and the applicable deadlines. Those deadlines vary by state and can be short. Nothing in this article is legal advice. No outcome is promised. Depending on your facts, you may be eligible to pursue a claim. That is a question for a lawyer, not for a website.

How Recalls Connect to Mass Tort Cases

Recalls and mass torts are separate things that sometimes overlap. A recall notice creates a public, dated record. It names the product, the defect, and the scope. For example, the Philips CPAP recall in 2021 involved sound-abatement foam that could degrade. That recall record later became a reference point in litigation brought by users who alleged injury.

The Takata airbag recalls followed a similar pattern. Millions of inflators were recalled across many vehicle brands over a period of years. Injured drivers and passengers brought claims, and the recall documentation helped establish what was known and when. However, in both examples, the recall did not decide anything by itself. Individual plaintiffs still had to prove injury and causation.

The same logic applies to the carefusion bd recall. The FDA record establishes the product, the hazard, the date, and the Class I severity. It does not establish that anyone was hurt. It does not establish liability. Whether any litigation follows this particular recall is not something this article can predict, and no lawsuit over it is asserted here.

Frequently Asked Questions

What product is affected by the carefusion bd recall?

The recall covers BD ChloraPrep Clear with 2% chlorhexidine gluconate and 70% isopropyl alcohol, in the 1 mL Applicator size, packed 60 per inner carton. The NDC is 54365-400-31. The recalling firm is CareFusion 213, LLC of El Paso, Texas, a subsidiary of Beckton, Dickinson and Co.

Why is this a Class I recall?

The FDA found the applicators were non-sterile due to Aspergillus penicillioides, a mold. Class I is the agency’s most serious classification. It means there is a reasonable probability that use of the product could cause serious health consequences or death.

Has anyone been injured by the recalled applicators?

The agency record does not state whether injuries have been reported. This article makes no claim in either direction. If you have symptoms after a procedure, contact a healthcare provider and mention the possible exposure.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

• U.S. Food and Drug Administration: official recall database — the record of truth for this notice
• CPSC: cpsc.gov — household goods, toys, furniture, appliances
• FDA: fda.gov — food, drugs, and medical devices
• NHTSA: nhtsa.gov — vehicles, tires, and child car seats
• USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed August 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.