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

Key Takeaways

• Baxter Healthcare has initiated a voluntary, nationwide Class II recall of Sterile Water for Irrigation, 250 mL single-dose bottles (NDC 0338-0004-02), affecting Lot G171359 (exp. 05/31/2027) and 125,496 bottles.
• Plastic particulate matter from the bottle rim was observed floating in the solution, posing a contamination risk during irrigation use.
• Sterile Water for Irrigation is used for wound, tissue, and surgical site irrigation; pharmacists should quarantine affected stock and follow Baxter’s return instructions.

Baxter Healthcare Corporation has initiated a voluntary nationwide recall of Sterile Water for Irrigation, 250 mL, single-dose plastic bottles (Rx only) after identifying particulate contamination. The affected product involves 125 496 bottles and is limited to lot G171359 with an expiration date of May 31, 2027. The recall is associated with recall number D-0296-2026 and Event ID 98178, with initial notification issued via letter. Distribution occurred nationwide, and the recall remains ongoing.

The US Food and Drug Administration (FDA) has classified this action as a Class II recall, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse outcomes is remote. The recall was firm-initiated and voluntary, beginning on December 22, 2025, with the FDA’s center classification dated January 23, 2026. No press release was issued for this recall, and there is no termination date at this time.

According to the FDA Enforcement Report, the reason for the recall is the presence of particulate matter, specifically plastic particles originating from the bottle rim that were observed floating in the solution. Such contamination poses a potential risk during irrigation procedures, particularly in surgical or wound care settings where sterility and particulate-free solutions are critical. Pharmacists should review inventory, quarantine affected lots, and follow firm instructions for return or disposal.

Sterile Water for Irrigation is indicated for irrigating and cleansing body cavities, tissues, or wounds during medical and surgical procedures and is not intended for injection.