The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1645-2026·Announced 2026-04-01

BD Alaris system labeling omits required TLS version for secure Wi-Fi

CareFusion is recalling the BD Alaris System with Guardrails Suite MX because the product labeling does not indicate which TLS version must be enabled on the hospital network for secure Wi-Fi communication.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers minor labelling errors: the recall corrects an omission in the product labeling, and the source describes no defect or malfunction in the device.

Plain-English summary

CareFusion 303, Inc. is recalling the BD Alaris System with Guardrails Suite MX with Point of Care Unit, catalogue number 8015. About 1,025,567 units were distributed worldwide, covering the United States nationwide and 29 other countries. The FDA has classified this recall as Class II.

The recall was initiated because the product labeling does not indicate which Transport Layer Security version must be enabled on the hospital network to ensure secure Wi-Fi communication with Point-of-Care Units. The source record does not describe a defect or malfunction in the device itself.

Affected product is listed by UDI-DI and serial number in the FDA enforcement record.

Facilities can identify affected units by the catalogue number and serial numbers, and may contact CareFusion 303, Inc. for further information.

The recalled product

Product
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion pump
Hazard
Affected units
1,025,567

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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