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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Topical Products

BD ChloraPrep Clear 1mL Applicators Recalled for Fungal Contamination

Agency Publication Date: March 7, 2025
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Summary

BD ChloraPrep Clear 1mL Applicators (chlorhexidine gluconate and isopropyl alcohol) are being recalled by CareFusion 213, LLC because the product may not be sterile. Verification found approximately 205,440 applicators are affected by a breach in the package lidding that allowed contamination with the fungus Aspergillus penicillioides. These applicators are used to prepare a patient's skin for medical procedures and surgery.

Risk

Using a non-sterile product contaminated with fungus on a patient's skin before surgery can lead to serious skin or systemic infections. This risk is particularly high for patients with weakened immune systems who are undergoing invasive procedures.

What You Should Do

  1. This recall affects BD ChloraPrep Clear 1mL Applicators (REF 930480, NDC 54365-400-31) from lot number 3200240 with an expiration date of June 30, 2026.
  2. Identify affected products by checking the lot number printed on the individual applicator lidding or the outer carton of 60 applicators.
  3. Stop using the recalled product immediately and quarantine any remaining inventory from the affected lot.
  4. Contact the manufacturer or your medical supply distributor to arrange for the return of any unused product.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: BD ChloraPrep Clear 1mL Applicators (1 mL)
Variants: 2% w/v chlorhexidine gluconate (CHG), 70% v/v isopropyl alcohol (IPA), Sterile Solution
Model:
930480
Lot Numbers:
3200240 (Exp 6/30/2026)
NDC:
54365-400-31

60 Applicators per Carton; Subsidiary of Becton, Dickinson and Co.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96262
Status: Active
Manufacturer: CareFusion 213, LLC
Manufactured In: United States
Units Affected: 205,440 applicators
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.