BD Alaris Point-Of-Care Units Recalled Over Network Connectivity and System Error Risks

Source: Health Canada · Canada

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Carefusion 303, Inc. has issued a recall for Alaris and BD Alaris Point-Of-Care Units (PCU) due to potential system errors and memory leaks caused by network security incompatibilities.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on February 22, 2026 and geographically references Canada. Its severity classification of "high" 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, health-canada, MedicalDevice) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Becton Dickinson (BD) is issuing a voluntary product communication regarding its Alaris and BD Alaris Point-of-Care Units (PCU). The recall was initiated because the product labeling does not specify which Transport Layer Security (TLS) versions must be enabled on hospital networks to ensure secure Wi-Fi communication.

Currently, Alaris and BD Alaris PCUs (version 12.1.3 and prior) are only compatible with TLS 1.0. If a hospital network disables TLS 1.0, the units will fail to connect to the wireless network. This failure can lead to interoperability issues requiring manual programming. Furthermore, if TLS 1.0 is disabled during use, the units may experience a memory leak following authentication failure. This leak consumes available memory over time and can lead to a system error, which may occur during active infusions.

Which Products Are Affected

The recall affects the following medical devices:

  • Product Name: Alaris & BD Alaris Point-Of-Care Unit (PCU)
  • Model Number: 8015
  • Software Versions: v12.1.3 and prior
  • Serial Numbers: More than 10 serial numbers are affected; consumers are advised to contact the manufacturer for specific details.
  • Manufacturer: Carefusion 303, Inc., based in San Diego, California.

What You Should Do

Healthcare facilities using these devices should ensure that TLS 1.0 remains enabled on their hospital networks to maintain secure Wi-Fi communication and prevent system errors. For facilities utilizing bi-directional workflows, be aware that network failures will require users to manually program the devices.

For additional information or to verify affected serial numbers, contact Carefusion 303, Inc. at 10020 Pacific Mesa Blvd., San Diego, California, 92121.

Why This Matters

A system error occurring during an active infusion poses a significant risk to patient safety, as it can disrupt the delivery of critical medications or fluids. Ensuring network compatibility is essential to preventing device malfunction in clinical settings.

Source

Health Canada

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Carefusion 303, Inc. has issued a recall for Alaris and BD Alaris Point-Of-Care Units (PCU) due to potential system errors and memory leaks caused by network security incompatibilities.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.