The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1230-2025·Announced 2025-03-05

BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling

CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.

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 is a Class II medical device recall involving missing contraindication language for high-risk clinical settings (procedure and operating rooms). Although no illnesses or injuries have been reported, this represents a risk-of-harm product requiring precautionary labeling correction.

Plain-English summary

The FDA has issued a recall for BD Pyxis MedBank medication management cabinets requiring a labeling update. The current labeling lacks a contraindication statement warning against use in procedure rooms and operating rooms.

Multiple models of the BD Pyxis MedBank system are affected, including the MedBank Mini and Tower configurations. These systems are distributed nationwide across all 50 U.S. states and Washington, D.C.

CareFusion 303, Inc. is the manufacturer of the affected systems. The FDA has classified this as a Class II recall.

The recalled product

Product
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
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 →

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