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Medline Recalls IV Administration Sets Over Stuck Valve Hazard

Medline Industries recalled 16 units of IV Administration Sets on November 26, 2025. Customers reported check valve components may become stuck, posing a risk during use. Healthcare providers should stop using these devices immediately and follow recall instructions.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesUDI/DI 10193489587869 (EA) 40193489587860 (CS)Lot Number 25HBQ850

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 26, 2025
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    November 26, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    April 13, 2026

  4. 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

  1. Locate the SKU DYNJ54488A on your packaging.
  2. Check the lot number to see if it is 25HBQ850.
  3. 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

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 10193489587869 (EA) 40193489587860 (CS)
Lot Number 25HBQ850
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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