Quick Facts at a Glance
- Recall Date
- November 26, 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
- IV Administration Sets
- Model numbers
- UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
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: Letter
About This Product
The Medline IV Administration Sets are medical devices used for the delivery of fluids and medications in healthcare settings. These sets are essential for patient care in hospitals and clinics, facilitating intravenous therapy.
Why This Is Dangerous
If the check valve components get stuck, it can prevent proper flow of fluids or medications, leading to potential treatment complications or patient harm.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers must cease use of the affected sets immediately, which may disrupt patient care and require sourcing of alternative supplies.
Practical Guidance
How to identify if yours is affected
- Locate the SKU DYNJ54488A on your packaging.
- Check the lot number to see if it is 25HBQ850.
- Verify that it contains B. Braun IV Administration Sets.
Where to find product info
Look for the SKU and lot number on the product's packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks.
If the manufacturer is unresponsive
- Document your attempts to contact Medline.
- Reach out to a regulatory body for assistance if necessary.
How to prevent similar issues
- Always verify the latest safety information on medical devices before use.
- Consider purchasing from manufacturers with a strong safety record.
Documentation advice
Keep records of your correspondence with Medline, including emails and any return shipping receipts.
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Product Details
The recalled product is the Medline kit SKU DYNJ54488A, which contains B. Braun IV Administration Sets and Pump Administration Sets. The affected lot number is 25HBQ850.
Key Facts
- Risk of stuck check valve components
- Stop use immediately
- Contact Medline for instructions
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Safety Guide
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