The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0369-2026·Announced 2025-11-05

Pyxis Pro auxiliary drawers recalled over fluid ingress causing smoke or fire

CareFusion is recalling 32 BD Pyxis Pro 7-Drawer Auxiliary units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

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: fluid ingress that may cause smoke or fire in a clinical dispensing unit is a hazard, and no injuries are reported.

Plain-English summary

Various models of BD Pyxis Pro 7-Drawer Auxiliary, reference numbers 1149-00 and 1152-00, are being recalled.

Potential fluid ingress of the anesthesia station or med station may result in smoke, system downtime and/or fire.

The recall covers 32 units across all serial numbers, carrying UDIs 10885403517822 and 10885403517839, distributed worldwide including nationwide in the United States and to Canada, the United Arab Emirates and Australia. The FDA has classified the action as Class II.

The enforcement record describes the failure mode and reports no injuries. Facilities operating affected units should follow the firm's instructions.

The recalled product

Product
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication dispensing
Hazard
Affected units
32

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 (1)

  • All Serial Numbers/Ref #/UDI: 1149-00 10885403517822 and 1152-00 10885403517839

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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