HIGH

Medline Recalls IV Administration Sets Due to Sticking Valves

Medline Industries recalled 33 units of IV Administration Sets on November 26, 2025. The recall follows customer complaints about check valve components potentially becoming stuck. This defect poses a high risk to patient safety and requires immediate action from healthcare providers.

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

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

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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

  1. Check the SKU number DYNJ63395B.
  2. Verify the model numbers UDI/DI 10195327634698 and 40195327634699.
  3. 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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI/DI 10195327634698 (EA) 40195327634699 (CS)
Lot numbers: 25HLA435
25HLB046.
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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