BD Alaris Pump Module, Infusion Sets Recalled Over Accuracy: Health Canada

Health Canada has published a Type II voluntary recall notice covering the BD Alaris Pump Module (model 8100) and a subset of compatible BD Alaris pump infusion sets, citing worse-than-documented performance under certain use cases. The notice was updated on September 28, 2026, and BD says a further updated recall notice is coming.

The recall involves products from Carefusion 303, Inc. of San Diego, California, and BD Switzerland Sarl of Eysins, Switzerland. It is aimed at healthcare facilities rather than the general public, and Health Canada lists the audience as Healthcare and Industry. The recall is registered under identification number RA-78122 with a recall date of September 12, 2025. The notice was first published on September 24, 2025.

Products Affected by This Recall

The affected products include the BD Alaris Pump Module, model 8100, and the BD Alaris PCU, model 8015. They also include a long list of compatible BD Alaris pump infusion sets. Health Canada describes these as a subset of the compatible sets and lists each one by model or catalogue number.

The listed sets cover several designs, including:

• Sets with back check valves and SmartSite Y-sites
• Sets with PE lined tubing and SmartSite bag access, non-vented
• A blood set with a 180 micron filter
• A yellow-striped microbore tubing set
• A burette set with smallbore tubing
• Sets with a bonded Texium closed male luer, including the Alaris LVP 20D Low Sorb

Among the catalogue numbers listed are 2430-0500, 2465-0007, 10010453, 10015414, 2426-0500, 2204-0007, 2202-0500, 2477-0007, 2206-0007, 11426964, 2420-0500, 10013361, 2441-0007 and 2466-0007. Several other numbers appear on the full notice. For every listed item, the lot or serial number field says more than 10 numbers apply and directs users to contact the manufacturer.

What Triggered the Recall

According to the notice, certain pump infusion set design features have been found to affect infusion performance. These include in-line filters, back check valves and Y-sites. The effect is most pronounced at programmable rates under 1 mL/h and at or under 1 mL of volume.

Compared with the performance described in the user manual, BD reports that flow rate accuracy and bolus dose accuracy have decreased for a subset of compatible sets. The time to alarm for upstream and downstream occlusions, along with the associated post-occlusion bolus, has increased.

The September 28, 2026 update widens the concern. BD says some Alaris pump sets with restrictive components and designs, such as closed male luers, filters, check valves, Y-sites and microbore tubing, 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. After further extensive testing, BD found that the performance it previously claimed was overestimated. In some instances, infusion performance is significantly worse.

Who Should Be Concerned

This is a healthcare-facility recall. Hospitals and clinics that use the BD Alaris Pump Module with the listed infusion sets are the main audience, along with clinicians who program low-rate or small-volume infusions. Health Canada also lists the general hospital and personal use device category for the product.

The Type II classification is a Health Canada designation. Health Canada lists the issue as Medical devices – Performance. The notice does not report any injuries, and it does not give the number of units affected.

What Facilities and Clinicians Should Do

The notice is a customer letter in which BD shares the latest performance data, repeats existing warnings and mitigations from the user manuals, and asks customers to acknowledge and share the notice within their institutions. Health Canada’s guidance on the recall page is short: contact the manufacturer if you require additional information.

• Check whether your facility uses model 8100 pump modules or any of the listed infusion set catalogue numbers.
• Review the user manual warnings and mitigations that BD has reiterated, especially for infusions at rates under 1 mL/h or small bolus volumes.
• Share the notice with clinical staff and pharmacy teams, as BD requests.
• Contact BD to get lot and serial number details and the latest set performance data.
• Watch for BD’s updated recall notice, which the company says it will issue.

Regulatory Response

Health Canada published the notice as a Health product recall under the category of Medical devices for general hospital and personal use. The department lists the recall class as Type II and the issue as a performance problem. Its page was last updated on September 28, 2026.

In the update, BD said it has continued to test its Alaris pump infusion sets extensively so that customers receive the most accurate set performance data. The company has not yet published the updated notice, so facilities should expect further changes to the guidance.

Anyone who needs more details on this recall should contact BD directly, using the manufacturer information supplied to customers. Health Canada also invites the public to report a health or safety concern through its online reporting page.