Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.
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: This is a risk-of-harm product (medication dispensing system) where no injuries have been reported, placing it at Score 3 (High) per the severity rubric. The FDA Class II classification and potential for serious medication errors (wrong dose, item, or timing) justify the High rating despite lack of confirmed harm.
Plain-English summary
CareFusion 303, Inc. is recalling four models of Pyxis medication and anesthesia dispensing systems. The affected devices are Pyxis MedStation ES (Catalog No. 323), Pyxis Anesthesia Station (Catalog No. 327), Pyxis MedStation ES Tower (Catalog No. 352), and BD Pyxis CII Safe ES (Catalog No. 1116-00). All serial numbers of these models with software version v1.10 and prior are affected. A total of 137,741 units have been distributed.
The recall is due to software issues that could potentially result in delays in accessing the dispensing software application, wrong therapy administration (including incorrect dose, medication item, or timing), or unauthorized access and compliance-related issues. These risks could compromise patient safety and medication management protocols.
The affected devices have been distributed domestically nationwide and internationally to North America, Latin America, EMEA, and Greater Asia. Healthcare facilities currently using these Pyxis systems should contact CareFusion 303, Inc. for information about remediation or replacement options.
The recalled product
- Product
- (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 137,741
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 (14)
- (1) Pyxis MedStation ES
- Catalog No. 323
- UDI-DI 10885403512667
- (2) Pyxis Anesthesia Station (PAS)
- Catalog No. 327
- UDI-DI 10885403477836
- (3) Pyxis MedStation ES Tower
- Catalog No. 352
- UDI-DI 10885403512674
- (4) BD Pyxis CII Safe ES
- Catalog No. 1116-00
- UDI-DI 10885403512605
- All Serial Numbers
- Software Versions v1.10 and prior Affected
Distribution
Distributed nationwide across the United States.
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