The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1932-2024·Announced 2024-06-05

BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 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: FDA Class II device recall involving a risk-of-harm hazard (fire and smoke from fluid ingress) with no reported illnesses or injuries to date. While the potential consequences are serious, the absence of reported incidents and the theoretical nature of the hazard (stated as 'may result') limits the severity to High rather than Severe.

Plain-English summary

The BD Pyxis Anesthesia Station 4000 (reference 338) is manufactured by CareFusion 303, Inc. and is being recalled by the FDA due to potential fluid ingress.

Potential fluid ingress of the anesthesia station may result in smoke, system downtime, and/or fire. The defect has been classified as FDA Class II.

The recall involves approximately 11,875 units with specific serial numbers. The affected units have been distributed worldwide, including throughout the United States and in multiple international markets.

Healthcare facilities that use this equipment should consult the provided list of affected serial numbers and contact the manufacturer or FDA for further information and guidance on remediation.

The recalled product

Product
BD Pyxis(TM) Anesthesia Station 4000, REF: 338
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Anesthesia Station
Hazard
Affected units
11,875

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 →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · fire

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