Recall Z-0234-2026
Medline Industries, LP · initiated September 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Codes / lots: UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
Reason for recall
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
FDA-determined 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.
Details
- Recall number
- Z-0234-2026
- Initiated
- September 11, 2025
- Posted by FDA
- October 23, 2025
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- 8,267,150 syringes
- Distribution
- Distribution US nationwide and Canada
- Recalling firm
- Medline Industries, LP, Northfield, IL