BD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue
CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.
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 involving a significant risk-of-harm medical device where a software defect could lead to unintended medication dispensing without pharmacist validation. No reported illnesses or injuries are stated in the source, but the bypass of required safety validation controls presents a direct risk to patient safety that justifies a High severity rating.
Plain-English summary
CareFusion 303, Inc. is recalling BD Pyxis MedBank Receiving Cabinet Software and associated hardware (approximately 2,679 units) distributed nationwide across 17 states: KS, TX, CA, PA, NJ, FL, IN, AZ, IL, MA, NY, KY, UT, MD, WA, OH, and AL.
The issue stems from a software malfunction: when the "Clear All selected medications" function is activated on a patient profile, the automated dispensing cabinet may allow medication to be removed without first requiring entry of the RxVerify Validation Code or confirmation from a pharmacist. This bypass of required validation steps could result in unintended or incorrect medication removal.
The affected software versions are 2.1.2.11, 2.2.1.8, 2.31.8, 2.3.2.1, and 2.4.2.26. Multiple hardware configurations are involved, identified by specific reference numbers and UDI codes listed in the FDA recall notice.
Affected healthcare facilities should contact CareFusion 303, Inc. for instructions on updating or correcting the software to restore the required validation safeguards.
The recalled product
- Product
- MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- medication-dispensing-error
- missing-validation
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 (20)
- BD Pyxis MedBank Receiving Cabinet Software Software versions: 2.1.2.11
- 2.2.1.8
- 2.31.8
- 2.3.2.1
- 2.4.2.26 REF/UDI-DI: 1119-00/10885403512704
- 1137-00
- 1139-00/10885403512704
- 1145-00/10885403517167
- 1147-00/10885403517181
- 139090-01
- 169-100/10885403512568
- 169-101/10885403512544
- 169-102/10885403512544
- 169-103/10885403512544
- 169-104/10885403512544
- 169-105/10885403512544
- 169-106/10885403512544
- 169-107/10885403512544
- 169-108/10885403512544
- 169-109/10885403512544
Distribution
Distributed nationwide across the United States.
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