FDAHealthSeptember 11, 2025

Medline Industries, LP — Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

⚠️ Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: September 11, 2025

Distribution US nationwide and Canada

What's affected?

Product: Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Brand: Medline Industries, LP
Lot code: 25AJA049

Additional details

UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 8,267,150 syringes.

View original FDA notice →

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