FDAFDA · Food and drugs·Recall number Z-0234-2026
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Published October 29, 2025 · Recall initiated: September 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- Distribution US nationwide and Canada
- Lot
- UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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