BD Alaris Pump Module and Compatible Infusion Sets Recall Over Performance Issues
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
BD is recalling the Alaris Pump Module model 8100 and subsets of compatible pump infusion sets due to worse infusion performance at low rates and volumes.
The full picture behind this Health Canada recall
This notice was issued by Health Canada on September 28, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, health-canada, medical-device.
What Happened
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 when used with a subset of compatible pump infusion sets. 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. An update notes that some Alaris™ pump sets with restrictive components perform worse than previously disclosed, with deviations most commonly occurring at low programmable rates under 1 ml/h and at or under 5 ml of bolus volume.
Which Products Are Affected
- BD Alaris™ Pump Module, model 8100 (more than 10 numbers, contact manufacturer)
- Subset of BD Alaris™ Compatible Pump Infusion Sets: 2430-0500, 10561554, 2465-0007, 10010453, 10010454, 11532269, 11171447 (more than 10 numbers for each, contact manufacturer)
What You Should Do
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.
Why This Matters
The deviations affect flow rate and bolus dose accuracy as well as occlusion alarm times for certain infusion sets used with the pump module.
Source
Original source: Health Canada Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Beyond this Health Canada recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,788 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 28, 2026.
Common Questions
What people usually ask about a notice like this one.