BD PYXIS Automated Dispensing Cabinet Software Issue Causes Incorrect Medication Bin Labels
A software issue in BD PYXIS automated dispensing cabinets may cause incorrect medication bin labels to print during restocking, potentially leading to medication dispensing errors. CareFusion is recalling 16 units.
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 for a risk-of-harm product (incorrect medication dispensing) with no reported illnesses or injuries. The potential for serious patient harm from medication errors justifies High severity despite lack of reported adverse events.
Plain-English summary
CareFusion 303, Inc. is recalling 16 units of the BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P automated dispensing cabinet system (software version 3.9.1.9). The product contains a software issue that may cause an incorrect bin location to be printed on restock labels for medications stored in the cabinet, potentially resulting in medication dispensing errors.
The affected units were distributed nationwide to healthcare facilities across the United States.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 16
Distribution
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 →Related recalls
Same manufacturer · CareFusion 303, Inc.
See all →- HighBD Pyxis MedBank Mini fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedStation ES fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Anesthesia Station fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis MedBank Tower fingerprint scanner may overheat and burn
FDA (Devices) · 2026-06-10
- HighBD Pyxis Mini Main cabinets may overheat at fingerprint scanner
FDA (Devices) · 2026-06-10
Same hazard · software defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighBD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling
FDA (Devices) · 2024-09-11
- HighBD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect
FDA (Devices) · 2025-04-30
- HighBD Pyxis QFill Medication Cabinet Software Bug Causes Incorrect Restock Labels
FDA (Devices) · 2024-09-11
- HighBD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue
FDA (Devices) · 2025-04-23
- HighBD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect
FDA (Devices) · 2024-12-18
- HighMedication dispensing cabinets recalled after a firmware update caused drawer failures
FDA (Devices) · 2025-12-31