Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels
BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.
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 recall of a high-risk medical device used in medication dispensing. No illnesses or injuries have been reported; however, the software defect creates a direct risk of medication dispensing errors. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
CareFusion 303, Inc. is recalling 12 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P automated medication dispensing cabinets (model reference 169-94, software version 3.9.1.9) distributed nationwide across the United States. The recalled units contain a software defect that causes an incorrect medication bin location to be printed on restock labels.
When restock labels are printed for medications stored in the dispensing cabinet, the label may indicate the wrong bin location for the medication. This labeling error could cause healthcare personnel to access or restock medications from an incorrect bin location.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 12
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighBD Pyxis QFill Medication Cabinet Software Issue Causes Incorrect Bin Labeling
FDA (Devices) · 2024-09-11
- HighBD Pyxis QFill Medication Cabinet Software Bug Causes Incorrect Restock Labels
FDA (Devices) · 2024-09-11
- HighBD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect
FDA (Devices) · 2025-04-30
- HighBD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect
FDA (Devices) · 2024-12-18
- HighAutomated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors
FDA (Devices) · 2024-12-18
- HighBD Pyxis MedBank System may dispense wrong medication due to software error
FDA (Devices) · 2023-01-18