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 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.
- 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
IV Administration Sets are medical devices used to deliver fluids and medications to patients. They are essential in various healthcare settings, including hospitals and outpatient care facilities.
Why This Is Dangerous
The recalled IV Administration Sets may have check valves that get stuck, which can disrupt proper fluid flow. This malfunction can lead to incorrect dosage delivery, which poses significant risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare facilities that rely on these IV Administration Sets for patient care. Immediate cessation of use may cause disruptions in treatment, necessitating replacements from alternative suppliers.
Practical Guidance
How to identify if yours is affected
- Check the SKU number DYNJ63395B.
- Verify the model numbers UDI/DI 10195327634698 and 40195327634699.
- Look for lot numbers 25HLA435 and 25HLB046.
Where to find product info
You can typically find model and lot numbers on the packaging or the product label of the IV Administration Set.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after contacting Medline.
If the manufacturer is unresponsive
- Contact Medline again and document your communication.
- Reach out to the FDA for further guidance on handling the recall.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Make sure to purchase from reputable suppliers with good safety records.
- Ask healthcare providers for guidance on safe IV Administration Sets.
Documentation advice
Keep records of your correspondence with Medline, as well as any receipts or packaging related to the recalled product.
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Product Details
The recall affects Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets. The affected SKU is DYNJ63395B, with model numbers UDI/DI 10195327634698 and 40195327634699. Lot numbers include 25HLA435 and 25HLB046.
Key Facts
- 33 units recalled nationwide
- Potential for serious health risks
- Immediate cessation of use required
- Contact Medline for further instructions
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Safety Guide
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