# FDA recall D-0296-2026

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2025-12-22.

## Product

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

## Reason for recall

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0296-2026
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-22
- **Report date:** 2026-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2026

## Citation

> AI Analytics. FDA recall D-0296-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0296-2026. Source: US FDA. Licensed CC0.

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