The FDA has posted 40 enforcement recalls of closed antineoplastic and hazardous drug reconstitution and transfer system devices since 2025, none of them Class I (most serious). Most recent report: May 27, 2026.
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption…
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System”). Informational only — verify against the FDA before acting.