The Recall Desk
HighFDA (Devices)·Z-1928-2024·Announced 2024-06-05

BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

What this means for you

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 Class II FDA recall for a medical device with a potential fire and smoke hazard. No incidents or injuries have been reported; the hazard is theoretical. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) severity score.

Plain-English summary

The BD Pyxis MedStation 4000 System, a medication cabinet used in healthcare settings, is the subject of a worldwide recall. Approximately 91,933 units have been distributed to healthcare facilities across the United States and internationally, including Canada, Australia, United Kingdom, and other countries.

The medication cabinet is recalled due to potential fluid ingress that may result in smoke, system downtime, and/or fire. CareFusion 303, Inc., the manufacturer, initiated this recall as a safety precaution.

Healthcare facilities using affected units should refer to the FDA recall notice for specific unit identifiers and contact CareFusion 303, Inc. for information on remediation, repair, or replacement options.

The recalled product

Product
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Dispensing System
Hazard
Affected units
91,933

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 · fluid ingress

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