FDAFebruary 11, 2026device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

carefusion 303carefusion

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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