BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination
BD is voluntarily recalling specific lots of ChloraPrep Clear 1 mL Single Sterile and FREPP Clear 1.5 mL applicators due to reports of fungal contamination found in products with paper lidding.
This affects BD (Becton, Dickinson and Company), healthcare facilities using topical antiseptic applicators, and logistics providers involved in the distribution of ChloraPrep and FREPP branded products.
A recall for microbial (fungal) contamination in a product intended for skin preparation prior to invasive procedures suggests a significant sterility assurance failure. For regulatory and quality teams, this underscores the risk of paper-based packaging integrity or environmental control issues during manufacturing. The contamination poses a risk of introducing pathogens directly into surgical sites or bloodstream access points, potentially leading to serious healthcare-associated infections.
Immediately quarantine affected lots 4032183 and 4073005. Conduct a physical inventory audit to ensure all paper-lidding applicators from these lots are removed from clinical use and follow the manufacturer's return or disposal instructions. Clinical sites should monitor for healthcare-associated infections that may be linked to contaminated skin prep materials.
FRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contami
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