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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.

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

Why it was recalled

BD Alaris System with Guardrails Suite MX with Point of Care Unit labeling does not specify which Transport Layer Security (TLS) version must be enabled on hospital networks to ensure secure Wi-Fi communication with Point-of-Care Units. This labeling gap may prevent proper network configuration and compromise secure device communication.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
10885403210747, 10885403210754, 10885403210891, 10885403212048, 10885403222108, 10885403224614, 10885403515231, 10885403516023, 10885403519215, 10885403519284, 10885403519291, 10885403801518, 10885403801532, 10885403801549, 12360968, 12360983, 12360985, 12360986, 12360987, 12360988

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from CareFusion 303, Inc.

All recalls from CareFusion 303, Inc.

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