← FDA ENFORCEMENT
Z-0234-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2025-10-29
Distribution
Distribution US nationwide and Canada
Firm state
IL
Product quantity
8,267,150 syringes
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →