FDAClass IINovember 5, 2025

All Serial Numbers/BD Pyxis CII Safe ES Tower Main recall

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

Why was All Serial Numbers/BD Pyxis CII Safe ES Tower Main recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Ref #/UDI: 1116-00 10885403512605

Product
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Recalling firm
CareFusion 303, Inc.
Quantity
443 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Recall date
November 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls