BD Pyxis automated medication systems recalled for missing antivirus software
BD Pyxis automated medication dispensing systems are recalled because antivirus software was not consistently installed during the implementation process, affecting 8,353 devices worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The issue is an antivirus software implementation oversight rather than a product design defect, making this a precautionary recall without evidence of actual harm.
Plain-English summary
BD Pyxis automated medication dispensing cabinets and related system components, manufactured by CareFusion 303, Inc., are subject to a Class II recall. These devices are used in healthcare facilities for secure medication storage and dispensing.
Antivirus software was not consistently installed on affected devices during the implementation process. The recall involves approximately 8,353 devices, including 6,738 units in the United States and 1,615 units outside the United States.
The devices have been distributed worldwide across all U.S. states and territories and numerous international locations. For guidance regarding this recall, healthcare facilities should contact CareFusion 303, Inc. or the FDA.
The recalled product
- Product
- BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- malware-risk
- security-vulnerability
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03