Key Insights
- BD broadens its Class I voluntary recall to include 15 additional Alaris™ pump infusion sets, citing new corrective actions and risk information.
- The recall, initiated July 8, 2025, highlights potential risks of over/under infusion and delayed alarms, particularly dangerous for neonates and critically ill patients.
- With distribution spanning the U.S., Canada, Belgium, and South Africa, the update signals global vigilance in infusion therapy safety.
BD’s updated recall follows internal testing that revealed infusion performance deviations, including flow rate accuracy issues, occlusion alarm delays, and post-occlusion bolus overinfusion. Although no patient complaints have been reported to date, the FDA classified the event as Class I—the most serious level—due to risks of death or severe adverse events.
Expanded Scope and Global Impact
The September 11 update added 15 discontinued infusion sets still in circulation, widening the recall footprint. With products distributed across multiple continents, the action reflects the international scale of infusion therapy reliance and underscores the importance of harmonized safety monitoring.
Corrective Actions and Risk Mitigations
BD advised customers on alternative Alaris™ pump infusion sets and outlined risk mitigations in its update. The company emphasized proactive communication, urging healthcare providers to report product-related complaints and adverse events directly to BD and the FDA’s MedWatch Program.
Reinforcing BD’s Commitment to Healthcare Trust
As one of the world’s largest medtech companies, BD positions this move as a reaffirmation of its mission to enhance care safety and efficiency. While recalls can temporarily challenge confidence, the company’s transparency and corrective strategy may ultimately strengthen its reputation as a trusted partner in advancing medical discovery, diagnostics, and delivery of care.
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