Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Prefilled saline IV flush syringes
- Model numbers
- 10363807000039, 363807000032, 363807100114, 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105 +1 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The product is a prefilled saline flush syringe used to rinse IV lines. It is designed for medical settings and used by healthcare professionals.
Why This Is Dangerous
A deviation in sodium chloride concentration could impact saline dosing and patient safety during IV flush procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to identify and remove affected syringes from stock and replace them to ensure correct saline concentration in patient care.
Practical Guidance
How to identify if yours is affected
- Identify if you have Excelsior Medical EMZ111240 10 mL prefilled saline flush syringes.
- Review Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
Where to find product info
UDI labels on case, box, and individual syringes; Lot numbers printed on packaging.
What timeline to expect
Refunds or replacements typically processed within 4-6 weeks after submission of disposition request.
If the manufacturer is unresponsive
- Document all communications with Medline
- If Medline is slow, file a complaint with the FDA via MedWatch or the recall page
- Consider escalation steps outlined on the recall notice.
How to prevent similar issues
- Verify supplier recalls during procurement.
- Check UDI and lot numbers before accepting shipments.
- Maintain an up-to-date recall log for critical medical supplies.
Documentation advice
Keep recall notices, purchase records, packaging images, and correspondence with Medline for records.
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Product Details
Excelsior Medical 0.9% Sodium Chloride Injection, USP — 10 mL fill, EMZ111240. Distribution: US nationwide and Canada. Item Number: EMZ111240. UDI codes and lots listed below.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity: 8,267,150 syringes recalled
- Brand: Excelsior Medical
- Product: 0.9% Sodium Chloride Injection, USP
- Item Number: EMZ111240
- Distribution: US nationwide and Canada
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Safety Guide
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