FDA-Device2025-10-29Class IIPROCESSING DEFECT
Medline Excelsior saline flush syringes recalled for incorrect sodium chloride concentration
What this means
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
The agency's original wording
Hazard
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Intended for
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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- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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