Baxter Healthcare Recalls Sterile Water for Irrigation Due to Plastic Particulate Matter

Source: FDA · United States

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Baxter Healthcare Corporation has recalled 125,496 bottles of Sterile Water for Irrigation after plastic particles from the bottle rim were found floating in the solution.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Baxter Healthcare Corporation has voluntarily initiated a recall of Sterile Water for Irrigation. The recall was prompted by the discovery of particulate matter, specifically plastic particles from the bottle rim, which were observed floating within the sterile solution. This recall has been classified by the FDA as Class II.

Which Products Are Affected

The recall affects 125,496 bottles of the following product:

  • Product Name: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle (Rx Only)
  • NDC: 0338-0004-02
  • Lot Number: G171359
  • Expiration Date: 05/31/2027
  • Recall Number: D-0296-2026

The product was distributed nationwide throughout the United States.

What You Should Do

Healthcare providers and consumers are advised to immediately stop using the affected lot. Baxter Healthcare Corporation notified customers of the recall via letter. Those in possession of the recalled product should follow the instructions provided in the notification for the return or disposal of the bottles. For additional inquiries, contact Baxter Healthcare Corporation at their headquarters in Deerfield, Illinois.

Why This Matters

The presence of foreign plastic particles in a sterile irrigation solution can lead to physical irritation, inflammation, or other complications if used during medical procedures. A Class II classification indicates that the use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information sourced from the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Baxter Healthcare Corporation has recalled 125,496 bottles of Sterile Water for Irrigation after plastic particles from the bottle rim were found floating in the solution.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.