Health Canada posts BD voluntary recall notice for Alaris

Cresthaven AnalyticsIntelligence Brief

Headline

Health Canada posts BD voluntary recall notice for Alaris Pump Module and compatible infusion sets

Executive Summary

BD has announced a voluntary recall of the BD Alaris Pump Module (model 8100), the BD Alaris PCU (model 8015), and a subset of compatible infusion sets spanning more than 40 catalogue numbers. The recall addresses worse pump performance in certain use cases when the pump module is used with a subset of compatible infusion sets, with design features such as in-line filters, back check valves and Y-sites identified as adversely affecting infusion performance. Health Canada's recalls and safety alerts database carries the notice.

Bottom Line

BD has announced a voluntary recall of the Alaris Pump Module (model 8100), the Alaris PCU (model 8015), and a subset of compatible infusion sets spanning more than 40 catalogue numbers, citing worse pump performance under certain use cases involving infusion sets with in-line filters and back check valves. The notice requests that customers acknowledge and disseminate it within their institutions.

Key Regulatory Signals

Voluntary Recall Scope: BD has initiated a voluntary recall covering the Alaris Pump Module (model 8100), the Alaris PCU (model 8015), and a subset of compatible pump infusion sets listed across more than 40 catalogue numbers. Lot and serial numbers for each product exceed ten entries; the notice directs customers to contact the manufacturer for the full list.
Performance Issue Under Specific Use Cases: BD states the recall addresses worse pump performance under certain use cases when the pump module is used with infusion sets that include design features such as in-line filters and back check valves. The notice does not characterize the severity tier of the recall.
Customer Dissemination Request: The notice requests that customers acknowledge receipt and disseminate the notice within their institutions. This is a request by BD, not a regulatory directive from Health Canada.
Updated Notice Announced: A September 28, 2026 update states that BD will issue an updated recall notice covering Alaris pump sets with restrictive components. Cresthaven reading: clinical facilities holding affected catalogue numbers face a pending second notice that may alter the scope or instructions currently in effect.

Regulatory Delta

No direct Health Canada precedent for a BD Alaris pump recall of this catalogue breadth has been identified in recent agency records. The scope, covering both pump hardware and infusion set subsets, is structurally broader than routine single-product device notices.
The recall is voluntary and initiated by BD. Health Canada's role is publication of the notice, not issuance of a binding order.
A parallel U.S. FDA recall record for the BD Alaris platform exists from prior years, indicating the Alaris pump line has been subject to recurring corrective actions across North American jurisdictions.

Materiality Classification

MEDIUM — Voluntary recall request by BD covering a widely deployed infusion pump platform across more than 40 catalogue numbers and multiple clinical infusion set variants, with a second updated notice announced as forthcoming; the population-scope rule applies because the notice lands on all clinical facilities holding affected catalogue numbers, not only a single named entity.

Intelligence Outlook

Monitor Health Canada's recalls and safety alerts database for BD's announced updated recall notice covering Alaris pump sets with restrictive components, and for any Health Canada classification or mandatory order associated with this voluntary action.