FDA Issues Early Alert for Medline Kits with Recalled Fungal-Contaminated Applicators

The U.S. Food and Drug Administration (FDA) has issued an "Early Alert" regarding Medline convenience kits containing recalled BD ChloraPrep applicators, which are recommended for removal due to potential fungal contamination.

Medline advised customers to remove these kits because certain environmental conditions may allow the growth of Aspergillus penicillioides. Contamination with this fungus can lead to serious health consequences, including systemic infection, sepsis, illness, and even death.

This action follows a Medline notification sent on June 12, 2026, and applies to convenience kits containing specific lots of BD ChloraPrep Clear 1 mL Single Sterile applicators (item 930480, lot 4032183) and FREPP Clear 1.5 mL applicators (item 930299, lot 4073005). If introduced into a patient's bloodstream, the fungus could necessitate catheter removal or surgical intervention for surgical site infections.

As of August 17, Medline has not reported any serious injuries or deaths related to this issue. The FDA's Center for Devices and Radiological Health (CDRH) said, "CDRH is issuing this 'Early Alert' to notify the public of a potentially high-risk device issue." The agency plans to provide updates as new information becomes available.