FDA Medical devices recall ·
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill… recall
- Recall number
- Z-0234-2026
- Date
- (initiated September 11, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8,267,150 syringes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Why was it recalled?
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
Distribution
Distribution US nationwide and Canada
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0234-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.