All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
FDA Recall #Z-0371-2026 — Class II — September 30, 2025
Product Description
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Reason for Recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Recalling Firm
CareFusion 303, Inc. — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
443 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Code Information
Ref #/UDI: 1116-00 10885403512605
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated