The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1930-2024·Announced 2024-06-05

BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

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 FDA Class II recall involves potential fluid ingress that could cause fire or smoke in a medical device. Without reported incidents but with serious potential consequences, this meets the criteria for a high-severity risk-of-harm product.

Plain-English summary

The BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower (REF: 306), manufactured by CareFusion 303, Inc., is subject to an FDA Class II recall. The recall involves 35,029 units with specific serial numbers.

Fluid may enter the anesthesia station or medication station portions of the device. If fluid ingress occurs, it could result in smoke generation, system downtime, and/or fire.

The affected units were distributed worldwide, including throughout all US states and territories, Canada, Australia, Japan, the United Kingdom, Mexico, and other countries.

Healthcare facilities with affected units should consult the FDA recall notice and contact CareFusion 303, Inc. for instructions on addressing this potential hazard in their specific devices.

The recalled product

Product
BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication/Anesthesia Dispensing Station
Hazard
Affected units
35,029

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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Same manufacturer · CareFusion 303, Inc.

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Same hazard · fire

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