Agency classClass IIOur severity:High FDA (Devices)·Z-2374-2024·Announced 2024-07-24

BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

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 for a software malfunction in automated medication dispensing cabinets. No illnesses or injuries have been reported. The hazard—a system error preventing medication access—is theoretical and occurs only under specific technical conditions, justifying a High severity per the rubric's provision for risk-of-harm products without reported incidents.

Plain-English summary

BD Pyxis automated dispensing cabinets are being recalled due to a software error that prevents users from accessing the dispensing application under specific conditions. The error occurs when all three of the following are present: the cabinet runs software version ES 1.7.x, Component Manager is configured to 'installed mode', and Windows security patch KB 5033688 has been installed in the production environment.

When this error occurs, users cannot access the medication dispensing software, which may delay access to medications for patients. The recall affects 326 units including MedStation ES (REF 323), MedStation ES Tower (REF 352), Anesthesia Station ES (REF 327), CII Safe ES, and desktop PC configurations with both wired and wireless scanners.

These units were distributed worldwide to locations in the United States and in Canada and Taiwan. CareFusion 303, Inc. is the manufacturer conducting the recall.

The recalled product

Product: BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop…
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Medication Dispensing Cabinet
Hazard: software-malfunction
medication-access-delay
Affected units: 326

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)

REF/UDI-DI: 323/10885403512667
352/10885403512674
327/10885403477836
1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745
16220738
16446299
16446303
16446302
16247443
16247440
15962990
16417275
16446297
16446296
16242783
16234266
15425093
16446295
16446291
16242784

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Same manufacturer · CareFusion 303, Inc.

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Same hazard · software malfunction