# FDA recall Z-1119-2025

> **CareFusion 303, Inc.** · Class II · device recall initiated 2025-01-08.

## Product

(1) Pyxis MedStation ES, Catalog No. 323;  (2) Pyxis Anesthesia Station (PAS), Catalog No. 327;  (3) Pyxis MedStation ES Tower, Catalog No. 352;  (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

## Reason for recall

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

## Distribution

Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.

## Key facts

- **Recall number:** Z-1119-2025
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-08
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1119-2025

## Citation

> AI Analytics. FDA recall Z-1119-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1119-2025. Source: US FDA. Licensed CC0.

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