Medication Dispensing Cabinet Software Defect Causes Incorrect Bin Labels
BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.
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 FDA Class II recall involves a software defect in a medication dispensing device that could result in incorrect medication placement, representing a risk-of-harm scenario. No injuries or illnesses have been reported, limiting the severity to High per the rubric's guidance that theoretical hazards without reported harm score at most 3.
Plain-English summary
CareFusion 303, Inc. is recalling BD PYXIS MEDBANK TWR MN CR-2HH-6FM automated medication dispensing cabinets (Model REF: 169-89) containing software version 3.9.1.9. The recall addresses a software defect that may cause restock labels to print with incorrect bin designations for stored medications.
When a restock label is printed for a medication stored in the cabinet, the software may direct the label to an incorrect bin location. If pharmacy or healthcare staff rely on these printed labels during restocking, medications could be placed in the wrong bin, potentially causing medication administration errors.
The recalled units were distributed nationwide throughout the United States. The specific affected unit is identified by serial number 16238928 and UDI 10885403512568.
Healthcare facilities and pharmacies should implement independent verification procedures to confirm correct bin placement during medication restocking, rather than relying solely on printed restock labels. Contact with the manufacturer is recommended to address the underlying software defect.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- software-defect
- medication-error
- mis-labeling
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: 16238928
Distribution
Distributed nationwide across the United States.
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