The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1227-2025·Announced 2025-03-05

BD PYXIS MEDBANK systems operating room contraindication labeling update

BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.

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 2/5 (Moderate).

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: This is a Class II device subject to a voluntary precautionary labeling update with no reported illnesses, injuries, or adverse events. The contraindication is being added to guide proper system placement and use in healthcare facilities.

Plain-English summary

BD PYXIS MEDBANK medication management systems (medicine cabinets) are the subject of a labeling update. The recalled units include various MEDBANK MINI, MEDBANK TOWER, MEDBANK MN 200, MEDBANK MN 500, MEDFLEX MN 1000, and MEDFLEX MN 2000 models manufactured by CareFusion 303, Inc. Approximately 6,075 units have been distributed nationwide throughout the United States.

The FDA is requiring manufacturers to update product labeling to include a contraindication statement. The updated labeling will specify that these medication management systems should not be used in procedure and operating rooms.

Healthcare facilities using these systems should obtain and review the updated labeling from the manufacturer. Ensure that PYXIS MEDBANK systems are not installed or used in procedure and operating room areas. Facilities should contact CareFusion 303, Inc. for updated labeling and guidance on proper system placement and use.

The recalled product

Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Management System
Hazard
Affected units
6,075

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 →

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Same manufacturer · CareFusion 303, Inc.

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