FDA recall Z-0234-2026

Medline Industries, LP · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-09-11
Report date
2025-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2026