Recall Z-0234-2026— Medline Industries, LP

Name: FDA recall Z-0234-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2025-09-11. It names one FDA 510(k) clearance: K173348. 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2025-09-11
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K173348 — 0.9% Sodium Chloride Injection, USPMedline Industries, Inc.·cleared 2018-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.