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Medline Recalls IV Administration Sets Over High Hazard Risk

Medline Industries recalled 338 IV Administration Sets on November 26, 2025. The recall stems from complaints about malfunctioning check valve components. Patients and healthcare providers must stop using these devices immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline kit SKU DYNJ0395085VUDI/DI 10198459313745 (EA) 40198459313746 (CS)Lot Number 25HMC337

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
Medline kit SKU DYNJ0395085V, UDI/DI 10198459313745 (EA) 40198459313746 (CS), Lot Number 25HMC337, Medline kit SKU DYNJ66311C, UDI/DI 10198459364556 (EA) 40198459364557 (CS), Lot Number 25KBG419, Medline kit SKU DYNJ86770, UDI/DI 10195327674229 (EA) 40195327674220 (CS) +6 more
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

These IV Administration Sets are essential for delivering intravenous fluids and medications in healthcare settings. Hospitals and clinics commonly use them for various medical procedures and patient care.

Why This Is Dangerous

The check valve malfunction can disrupt the flow of fluids, potentially leading to inadequate or excessive medication delivery, which poses a significant risk to patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must act quickly to avoid using potentially defective devices, which can lead to serious health consequences.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU numbers on your Medline kits.
  2. Confirm against the recalled list provided in the recall announcement.
  3. Look for any lot numbers specified in the recall details.

Where to find product info

SKU numbers and lot numbers can typically be found on the product packaging or accompanying documentation.

What timeline to expect

Expect a timeline of 4-6 weeks for processing refunds or replacements, depending on the manufacturer's response.

If the manufacturer is unresponsive

  • Contact Medline Industries directly for assistance.
  • Keep documentation of your communications and attempts to resolve the issue.

How to prevent similar issues

  • Always check for the latest recall information before using medical devices.
  • Look for certifications and safety warnings on medical products before purchase.

Documentation advice

Document all communications with the manufacturer, including dates, names, and details of conversations.

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Product Details

The recall includes Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets. Specific SKUs affected are DYNJ0395085V, DYNJ66311C, DYNJ86770, and DYNJ909643F. These products were distributed nationwide in the U.S.

Key Facts

  • Recalled on November 26, 2025
  • Risk of malfunctioning check valves
  • 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
Medline kit SKU DYNJ0395085V
UDI/DI 10198459313745 (EA) 40198459313746 (CS)
Lot Number 25HMC337
Medline kit SKU DYNJ66311C
UDI/DI 10198459364556 (EA) 40198459364557 (CS)
+9 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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