The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2502-2024·Announced 2024-08-14

Automated Dispensing Cabinet Software Issue Causing Incorrect Medication Bin Labels

A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.

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 a Class II recall with no reported hospitalizations, illnesses, or injuries. The software defect creates a risk of medication dispensing errors in an automated dispensing system, meeting the criterion for high-risk products where injury has not yet been reported.

Plain-English summary

The BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P automated dispensing cabinet containing software version 3.9.1.9, manufactured by CareFusion 303, Inc., is subject to a Class II recall. A software defect can cause the incorrect medication bin location to be printed on restock labels. If pharmacy staff rely on these printed labels when retrieving or restocking medications, they may access the wrong bin, potentially resulting in medication dispensing errors.

This unit has been distributed nationwide throughout the United States.

Healthcare facilities and pharmacies using this equipment should verify the accuracy of all restock labels before using them for medication retrieval or storage operations. Contact CareFusion 303, Inc. for guidance on software updates or other corrective measures. No illnesses or injuries have been reported to date.

The recalled product

Product
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
Affected units
1

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 (1)

  • UDI: 10885403512568/ Serial Number: 16261297

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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