BD Broadens Recall of Alaris Infusion Sets Over Safety Risks

BD (Becton, Dickinson and Company)  has expanded its Class I recall of Alaris pump infusion sets to include 15 more models, following internal testing that revealed performance issues that could result in serious harm or death. The U.S. Food and Drug Administration published the company’s updated notice.

Although the infusion sets had already been discontinued, BD cautioned that some may still be in use. The company emphasized that it has not received any complaints to date but issued warnings after identifying risks such as inaccurate fluid delivery, delayed blockage alarms, or sudden release of large volumes once obstructions are cleared.

Patients in critical care, neonatal, infant, and pediatric settings are considered most vulnerable. BD advised healthcare providers to use alternate Alaris infusion sets or syringe modules when available and to prioritize their use for high-risk patients. If no alternatives exist, the recalled devices may be used only with heightened clinical monitoring.

27-09-2025