Baxter Healthcare Recalls Sterile Water for Irrigation Due to Plastic Particulate Matter
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
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