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Medline Recalls IV Administration Sets Due to Valve Failure Risk

Medline Industries recalled 1,725 IV Administration Sets on November 26, 2025. The recall affects multiple kits due to potential valve malfunctions. Consumers and healthcare providers must stop using these devices immediately.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline kit SKU DYKS1339BUDI/DI 10195327386726(EA) 40195327386727 (CS)Lot Number 25HMC849

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
7/10

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 DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS), Lot Number 25HMC849, Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS), Lot Number 25IMG807, Lot Number 25JMF937, Medline kit SKU DYKS1359B +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

Medline IV Administration Sets are used in healthcare settings for delivering fluids and medications to patients. These devices are essential for patient care during various medical procedures.

Why This Is Dangerous

The check valve malfunction can prevent proper fluid flow, potentially endangering patient safety during treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the affected products immediately to avoid potential health risks. This recall may cause disruptions in healthcare services.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU number on your IV Administration Set packaging.
  2. Verify if it matches any of the recalled SKUs: DYKS1339B, DYKS1339C, DYKS1359B, DYKS1534D.
  3. Contact Medline Industries if you are unsure about the recall status.

Where to find product info

SKU numbers can typically be found on the product box or label.

What timeline to expect

Expect to wait 4-8 weeks for a refund or replacement to be processed after returning the product.

If the manufacturer is unresponsive

  • Reach out to Medline Industries again for follow-up.
  • Document your communications with Medline for your records.
  • Consider filing a complaint with the FDA if you receive no response.

How to prevent similar issues

  • Look for devices with current safety certifications.
  • Research product recalls before purchasing medical devices.
  • Choose reputable manufacturers with good safety records.

Documentation advice

Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.

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Product Details

The recall includes Medline kits with SKUs DYKS1339B, DYKS1339C, DYKS1359B, and DYKS1534D. These products were distributed across the United States. They were sold under Medline Industries, LP.

Key Facts

  • Recalled kits: DYKS1339B, DYKS1339C, DYKS1359B, DYKS1534D
  • Quantity recalled: 1,725 units
  • Stop using the devices immediately
  • Contact Medline for instructions
  • High hazard classification

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Medline kit SKU DYKS1339B
UDI/DI 10195327386726(EA) 40195327386727 (CS)
Lot Number 25HMC849
Medline kit SKU DYKS1339C
UDI/DI 10198459523434(EA) 40198459523435 (CS)
+9 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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