# FDA recall Z-0368-2026

> **CareFusion 303, Inc.** · Class II · device recall initiated 2025-09-30.

## Product

Various models of  BD Pyxis MedFlex, Reference numbers: 1119-00  1139-00  139038-01  139039-01  139040-01  139041-01  139043-01  139044-01  139045-01  139046-01  139049-01  139051-01  139052-01  139053-01  139054-01  139055-01  139056-01  139058-01  139059-01  139060-01  139061-01  139064-01  139065-01  139066-01  139067-01  139068-01  139069-01  139070-01  139071-01  139072-01  139164-01  139165-01  300

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0368-2026
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-30
- **Report date:** 2025-11-05

- **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-0368-2026

## Citation

> AI Analytics. FDA recall Z-0368-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0368-2026. Source: US FDA. Licensed CC0.

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