The Recall Desk
ModerateFDA (Devices)·Z-1229-2025·Announced 2025-03-05

BD PYXIS medication cabinets labeling update: operating room contraindication

CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II labeling update with no reported illnesses or injuries. The recall is a preventative labeling correction adding a contraindication statement rather than addressing a physical product defect. The hazard is theoretical and addressed through instructional correction.

Plain-English summary

BD PYXIS MEDFLEX and MEDBANK medication management cabinet systems are subject to a labeling update issued by CareFusion 303, Inc. The update adds a contraindication statement warning against use of these medication cabinets in procedure and operating rooms.

The recalled units include multiple models of BD PYXIS MEDFLEX MN 1000, MEDFLEX MN 2000, and BD PYXIS MEDBANK cabinet systems distributed nationwide. The recall does not involve a product removal, but rather a labeling correction to ensure proper use of the devices.

Healthcare facilities that have received BD PYXIS medication cabinets should implement the contraindication statement and ensure that these devices are not used in procedure or operating room settings. The FDA classification for this recall is Class II.

The recalled product

Product
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Management System
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · missing contraindication

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