Z-0371-2026Class II

CareFusion 303, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2025-11-05

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Firm state

Product quantity

443 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

Code / lot info

Ref #/UDI: 1116-00 10885403512605

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →