The Recall Desk
Severity pendingFDA (Devices)·Z-1645-2026·Announced 2026-04-01

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

Pending LLM rewrite. Source: FDA_DEVICE Z-1645-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

The recalled product

Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Manufacturer
CareFusion 303, Inc.

Distribution

Distributed nationwide across the United States.