The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2485-2024·Announced 2024-08-14

Automated medication cabinet software prints incorrect bin labels

The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

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: FDA Class II medical device recall involving a software issue that creates risk of medication errors through incorrect bin labeling. No illnesses or injuries have been reported; the hazard remains theoretical rather than confirmed.

Plain-English summary

CareFusion 303, Inc. has recalled the BD PYXIS MEDBANK MINI CR-2HH-1FH-P automated medication dispensing cabinet system (software version 3.9.1.9) due to a software defect. The issue causes incorrect bin location information to be printed on restock labels for medications stored in the cabinet.

The recall affects 84 units that were distributed nationwide throughout the United States. The affected devices are identified by UDI 10885403512544 and specific serial numbers provided in the FDA notice.

When staff restock medications using incorrect bin location labels, medications may be placed in wrong locations within the cabinet. This could potentially result in medication dispensing errors if the incorrect placement is not detected and corrected. Facilities operating affected units should review the FDA notification for guidance on remediation.

The recalled product

Product
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Dispensing Cabinet
Hazard
Affected units
84

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 19 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 19 products in this recall →

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