Recall archive / FDA device enforcement
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush sy... — FDA record Z-0234-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
- Reason
- Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 8,267,150 syringes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0234-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158, |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide and Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Sep 11, 2025
- Center classification date
- Oct 23, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.