FDA-Device2025-10-29Class IIPROCESSING DEFECT
Medline Excelsior saline flush syringes recalled for incorrect sodium chloride concentration
Medline saline flush syringes recalled for concentration issue
Medline Industries identified a limited quantity of prefilled saline flush syringes (0.9% Sodium Chloride Injection, USP, 10 mL) that may not contain the correct concentration of sodium chloride. The affected syringes were distributed nationwide in the US and Canada.
- Check if your syringes match the affected lot numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, or 25CJA158
- Do not use syringes from the affected lots
- Contact Medline for instructions on return or replacement
Hazard
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Who it affects
Adults
Illnesses reported
None reported
Sold states
Distribution US nationwide and Canada
Affected count
8,267,150 syringes
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2026More Medline recalls
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