Agency classClass IIOur severity:High FDA (Devices)·Z-0962-2026·Announced 2025-12-31

Medication dispensing cabinets recalled after a firmware update caused drawer failures

CareFusion 303 is recalling 53,669 BD Pyxis automated dispensing cabinet units after a drawer firmware update caused a duplicate address error and drawer failure.

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: Scored 3 under the risk-of-harm criterion: the firm states drawer failure may delay access to stored medications, and no injuries are reported.

Plain-English summary

BD Pyxis MedStation ES and related automated dispensing cabinets, including REF 323, REF 324, REF 352, the BD Pyxis Pro 7-Drawer Auxiliary (REF 1149-00) and the BD Pyxis Pro 7-Drawer Auxiliary with Secure Tower (REF 1152-00), are being recalled by CareFusion 303, Inc.

Automated Dispensing Cabinets received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event prompting the software to generate a duplicate address. The firm states this causes an error and the drawer to fail, which may lead to an inability or delay in accessing stored items, delay in the replenishment of the cabinets, or medications specific to a patient being stored outside of them.

The record lists 53,669 units running firmware version 1.48, with REF and UDI-DI pairings listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Colorado, Indiana, Ohio, Texas, Kansas, Florida, Georgia, North Carolina, California, Hawaii and Illinois among other states. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow the firm's instructions.

The recalled product

Product: BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation…
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Dispensing cabinet
Hazard: firmware-fault
drawer-failure
medication-access-delay
Affected units: 53,669

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667
324/10885403512681
352/10885403512674
1149-00/10885403517822
1152-00/10885403517839
1155-00/10885403521300
1116-00/10885403512605

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

Same manufacturer · CareFusion 303, Inc.

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