Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syri
Summary
The FDA issued a Class II for Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number by Medline Industries, LP. Reason: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride..
Details
Source
Device Recall
External ID
Z-0234-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product Description
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Lot/Code Info: UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
Quantity Affected: 8,267,150 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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-11
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0234-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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