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BD Alaris System with Guardrails Suite MX
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MEDICAL DEVICE RECALLMODERATE

BD Alaris System with Guardrails Suite MX

BD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.

What to do

Contact CareFusion 303, Inc. for updated labeling that specifies the required Transport Layer Security (TLS) version for your hospital network configuration. Verify your network meets the TLS requirements before deploying or continuing use of the Point-of-Care Units.

Posted
Updated
Recall No.
Z-1645-2026
Agency
Firm
CareFusion 303, Inc.
Recall ID
98250
Status
ONGOING

Why it was recalled

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

How to identify it

UPC 10885403210747 10885403210754 10885403210891 10885403212048 10885403222108 10885403224614 10885403515231 10885403516023

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

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification