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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Excelsior Medical Saline Flush Syringes Recalled for Incorrect Concentration

Agency Publication Date: October 23, 2025
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Summary

Medline Industries, LP is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride Injection (saline flush) syringes. The recalled 10 mL prefilled syringes may not meet the required concentration of sodium chloride (salt). These syringes are commonly used to flush intravenous (IV) catheters in clinical settings.

Risk

Using a saline flush with an incorrect salt concentration can lead to electrolyte imbalances or ineffective cleaning of a patient's medical lines. While no specific injuries have been reported in this data, incorrect concentrations in medical flushes pose a risk to patient safety during treatment.

What You Should Do

  1. This recall affects Excelsior Medical 0.9% Sodium Chloride Injection, USP (10 mL Fill) prefilled saline flush syringes, identified by Item Number EMZ111240.
  2. Check your clinical supply for lot numbers 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, and 25CJA158. You can also identify the affected products by the Unique Device Identifiers (UDI) on the packaging: 10363807000039 (Case), 363807000032 (Box), or 363807100114 (Each).
  3. Stop using the recalled product. Contact Medline Industries, LP or your distributor to arrange for a return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill
Variants: 10 mL Fill, Prefilled saline flush syringes
Model / REF:
EMZ111240
Lot Numbers:
25AJA049
25BJA001
25BJA032
25CJA053
25CJA105
25CJA158
UDI:
10363807000039
363807000032
363807100114

Medline has identified a limited quantity that may not meet the required concentration of sodium chloride.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97675
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Authorized distributors; Hospital supply channels
Manufactured In: United States
Units Affected: 8,267,150 syringes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.