FDA-Drug2026-02-04Class IIPACKAGING DEFECT
Baxter Sterile Water for Irrigation recalled for plastic particles in solution
Stop using Baxter Sterile Water for Irrigation
Baxter Healthcare's Sterile Water for Irrigation 250 mL bottles may contain small plastic particles that came loose from the bottle rim and entered the solution. This affects lot G171359 with an expiration date of 05/31/2027. No injuries have been reported.
- Stop using any bottles from lot G171359 (expiration 05/31/2027)
- Check your supply for the affected lot number on the label
- Contact your healthcare provider or pharmacy if you have used this product
- Do not use the product for irrigation or any other purpose
Hazard
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Who it affects
Adults
Illnesses reported
None reported
Sold states
Nationwide
Affected count
125,496 bottles
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2026More Baxter recalls
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- FDA-Device2026-07-08Baxter operating table head positioning adapter recalled for loosening risk
- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT AC recalled for nebulizer cup leakage risk
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