Agency classClass IIOur severity:High FDA (Devices)·Z-1550-2025·Announced 2025-04-16

BD Pyxis MedBank CUBIE Replenishment Station software issue

A software issue in the BD Pyxis MedBank CUBIE Replenishment Station prevents medication restocking when users receive an error message, potentially delaying patient access to medications.

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 3/5 (High).

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 of a medical device used in medication dispensing. The hazard—potential delays in patient access to medications—poses a direct risk of harm to patient care, even though no illnesses or injuries have been reported. The risk-of-harm nature of the defect in a critical care delivery device warrants a High severity rating.

Plain-English summary

CareFusion 303, Inc. is recalling BD Pyxis MedBank CUBIE Replenishment Stations due to a software issue. When users attempt to restock the automated dispensing cabinet, they may receive a banner message stating "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance." When this error message appears, the medication cannot be restocked.

This issue can potentially lead to delays in accessing medication for patients. The recall affects 404 systems distributed across the United States, including Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

Customers who have received affected units should contact CareFusion 303, Inc. for further assistance and resolution of the software issue.

The recalled product

Product: BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD…
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Automated Dispensing Cabinet
Hazard: software-defect
medication-access-delay
Affected units: 404

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Product / Material ID / GTIN OPT
MEDBANK
HD
WIN10
QFILL

Distribution

Distributed in 32 states:

Same manufacturer · CareFusion 303, Inc.

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