Sodium Chloride Injection (Excelsior) – Concentration Deviation (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Lot Codes / Batch Numbers
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
Products Sold
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
A medical device manufacturer is recalling Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefill due to Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026