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

In the June 6, 2026 FDA Recalls (Devices) announcement, BD (Becton, Dickinson and Company) has issued a nationwide recall for specific lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL applicators due to microbial contamination. The affected lots are lot 4032183 of the ChloraPrep™ Clear 1 mL applicators and lot 4073005 of the FREPP™ Clear 1.5 mL applicators with paper lidding, used for skin preparation prior to surgical procedures.

The recall involves these specific products due to fungal contamination detected during routine quality control tests. This issue might lead to infections or other complications if used during surgical procedures. The recall affects the consumer level, indicating that hospitals and healthcare facilities should cease using the affected lots immediately and quarantine them until further instructions are received from BD.

These applicators are commonly used in various settings such as hospital central service departments (CSSD), operating rooms (OR), endoscopy units, and dental clinics for skin preparation before surgical procedures to minimize the risk of infection. As per the FDA guidelines, skin preparation is a critical step in maintaining sterility during surgeries, and any contamination could potentially lead to postoperative complications.