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

This recall is currently active, issued October 23, 2025.

Recall Initiated

September 11, 2025

Posted

October 23, 2025

Recall Number

Z-0234-2026

Quantity

8,267,150 syringes

Firm Location

Northfield, IL

Official Source

View on FDA website ↗

Reason for Recall

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

Distribution

Distribution US nationwide and Canada

Lot / Code Info

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

Root Cause

Process control

Action Taken

Medline issued an Urgent Medical Device Recall notice to its consignees on 9/11/2025 via email and mail. The notice discussed the issue, potential risk, and noted that affected boxes of syringes were also inadvertently packaged within cases of syringe lots that meet all requirements and were still safe for use. Within the item number, EMZ111240, the firm specified which lots were to be destroyed and which lots were safe to use. Cases of certain lots labeled with safe to use codes must be opened and inspected for affected units which must be destroyed. A response is required to receive credit for the destroyed affected units. For questions, please contact the Recall Department at 866-359-1704 or recalls@medline.com.