The Recall Desk
HighFDA (Devices)·Z-0670-2025·Announced 2024-12-18

BD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect

An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medication dispensing device with a software defect that may cause incorrect medication dispensing. Since the source describes potential consequences without reporting any actual illnesses or injuries, this meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The BD Pyxis MedStation ES, model REF 323, is an automated medication dispensing cabinet distributed worldwide, including throughout the United States and many other countries. All software versions of this device are subject to this recall. Approximately 98,526 units have been distributed globally.

A software issue may cause the device to open the wrong storage pocket or position when a medication is selected. This can result in unintended and incorrect medication being removed from the cabinet. Additionally, a different medication may be refilled or loaded into the cabinet in error.

When incorrect medication is dispensed and the wrong medication is reloaded, this may lead to low inventory levels or stockouts. The manufacturer, CareFusion 303, Inc., is conducting this recall of the affected devices.

The recalled product

Product
BD Pyxis MedStation ES, REF: 323
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Medication Dispensing Cabinet
Hazard
Affected units
98,526

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

Part of a larger recall action

This product is one of 3 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · medication dispensing error

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