The Recall Desk
HighFDA (Devices)·Z-0371-2026·Announced 2025-11-05

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

Pending LLM rewrite. Source: FDA_DEVICE Z-0371-2026.

What this means for you

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: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00
Manufacturer
CareFusion 303, Inc.

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)

  • Ref #/UDI: 1116-00 10885403512605

Distribution

Distributed nationwide across the United States.