The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1931-2024·Announced 2024-06-05

BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk

CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.

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 addresses potential fire and smoke hazards from fluid ingress into the device. No injuries or illnesses are reported in the source text. Per the severity rubric, this qualifies as High: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling the BD Pyxis Anesthesia Station ES, REF: 327, a medication dispensing system used in anesthesia settings. Approximately 71,569 units have been distributed worldwide.

The device may experience fluid ingress, which could result in smoke, system downtime, or fire. This potential hazard affects the safe operation and reliability of the device in clinical anesthesia environments.

The affected units have been distributed throughout the United States and internationally to numerous countries including Canada, Australia, Japan, the United Kingdom, South Korea, China, and others. Healthcare facilities with this device are potentially affected.

The FDA has assigned this recall the number Z-1931-2024. Affected devices can be identified using the UDI 10885403512636 and the specific serial numbers listed in the official recall notice.

The recalled product

Product
BD Pyxis" Anesthesia Station ES, REF: 327
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
71,569

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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