# FDA recall Z-0430-2026

> **CareFusion 303, Inc.** · Class I · device recall initiated 2025-10-17.

## Product

BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide

## Reason for recall

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

## Distribution

Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.

## Key facts

- **Recall number:** Z-0430-2026
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-17
- **Report date:** 2025-11-26

- **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-0430-2026

## Citation

> AI Analytics. FDA recall Z-0430-2026. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0430-2026. Source: US FDA. Licensed CC0.

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