BDX · 10-Q · 2026Q2 · Full report

Product Launch and Transition

BECTON DICKINSON & CO · 2026-08-06 · Importance 34 · Surprise 42 · In source text

BD’s updated BD Alaris Infusion System received FDA 510(k) clearance in July 2023, supporting remediation and the system’s return to the U.S. market. The clearance includes updated hardware for PCU, large-volume, syringe and PCA pumps, respiratory monitoring and auto-identification modules. It also includes software with enhanced cybersecurity and interoperability features for connectivity with electronic medical record systems. BD is remediating or replacing devices at U.S. customer sites with the updated cleared version and expects the effort to be substantially complete during calendar 2026.

Key facts

• Charges recorded to Cost of products sold to adjust future costs estimated for certain product remediation efforts were $57 million in the nine-month period of fiscal year 2026 and $98 million in the nine-month period of fiscal year 2025. source
• In accordance with commitments to the FDA, the overall timing of replacement of the BD Alaris™ Infusion Systems and return to market in the U.S. may be impacted by customer readiness, supply continuity and continued engagement with the FDA. source

Impact estimates