Z-0234-2026Class II

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

Name: Z-0234-2026 Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline...
Creator: Medline Industries, LP
Published: 2025-09-11
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-09-11 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes on 2025-09-11. FDA classified it as Class II and gives the reason as "Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0234-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-11
Posted: 2025-10-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Product code: NGT Saline, Vascular Access Flush
Reason for recall: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline issued an Urgent Medical Device Recall notice to its consignees on 9/11/2025 via email and mail. The notice discussed the issue, potential risk, and noted that affected boxes of syringes were also inadvertently packaged within cases of syringe lots that meet all requirements and were still safe for use. Within the item number, EMZ111240, the firm specified which lots were to be destroyed and which lots were safe to use. Cases of certain lots labeled with safe to use codes must be opened and inspected for affected units which must be destroyed. A response is required to receive credit for the destroyed affected units. For questions, please contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 8,267,150 syringes
Distribution: Distribution US nationwide and Canada
Product codes and lots: UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0234-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0234-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-23

Product code NGT

K173348Class II0.9% Sodium Chloride Injection, USPMedline Industries, Inc. / cleared 2018-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)