FDAClass IIOctober 29, 2025

Excelsior Medical recall

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

Why was Excelsior Medical recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Recalling firm
Medline Industries, LP
Quantity
8,267,150 syringes
Distribution
Distribution US nationwide and Canada
Recall date
October 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls