BD Alaris™ Pump Module and subset of Compatible Pump Infusion Sets Recall: BD is initiating this voluntary

Why this product was recalled

BD is initiating this voluntary recall notice to inform customers of worse performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets (see Appendix A). Pump infusion set design features such as in-line filters, back check valves, and Y-sites were identified to adversely impact infusion performance, particularly at programmable rates under 1 mL/h and at or under 1 mL of volume. Compared to the performance described in the user manual, the flow rate and bolus dose accuracy for a subset of compatible pump infusion sets have decreased, and the time to alarm for upstream and downstream occlusions and associated post-occlusion bolus have increased. In this letter, BD is sharing the latest performance data, reiterating existing warnings and mitigations from user manuals, and requesting customers to acknowledge and disseminate this notice within their institutions. Update (2026-09-28): BD will issue an updated recall notice as some Alaris™ pump sets with restrictive components and designs (e.g., closed male luer, filters, check valves, y-sites, microbore tubing, etc.) Perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 ml/h and at or under 5 ml of "bolus volume". BD has continued to extensively test BD Alaris™ pump infusion sets to ensure the most accurate set performance data is shared with our customers. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.

Hazard

BD is initiating this voluntary recall notice to inform customers of worse performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets (see Appendix A). Pump infusion set design features such as in-line filters, back check valves, and Y-sites were identified to adversely impact infusion performance, particularly at programmable rates under 1 mL/h and at or under 1 mL of volume. Compared to the performance described in the user manual, the flow rate and bolus dose accuracy for a subset of compatible pump infusion sets have decreased, and the time to alarm for upstream and downstream occlusions and associated post-occlusion bolus have increased. In this letter, BD is sharing the latest performance data, reiterating existing warnings and mitigations from user manuals, and requesting customers to acknowledge and disseminate this notice within their institutions. Update (2026-09-28): BD will issue an updated recall notice as some Alaris™ pump sets with restrictive components and designs (e.g., closed male luer, filters, check valves, y-sites, microbore tubing, etc.) Perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 ml/h and at or under 5 ml of "bolus volume". BD has continued to extensively test BD Alaris™ pump infusion sets to ensure the most accurate set performance data is shared with our customers. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.

Official recall notice

BD Alaris™ Pump Module and subset of Compatible Pump Infusion Sets

Agency: Health Canada

Official publication date: September 28, 2026

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