HIGH

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.

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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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.

The Hazard

The check valve components in the IV Administration Sets may become stuck in either the open or closed position. This malfunction can lead to improper fluid delivery, posing a risk to patient safety.

Reported Incidents

The recall was issued following customer complaints. No specific incidents of injury have been reported at this time.

What to Do

Stop using the recalled IV Administration Sets immediately. Contact Medline Industries for further instructions and follow the recall guidance provided in the notification letter.

Contact Information

For more details, contact Medline Industries, LP. Visit the FDA website for additional information on the recall.

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

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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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