HIGH

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 5,314 IV Administration Sets on November 26, 2025. The recall affects several product SKUs due to potential failure of check valve components. Patients and healthcare providers should 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 recalled products include Medline kit SKUs DYKM1980C, DYKM2137B, DYKS1372C, DYNDV1691B, and DYNDV2464A. These kits were distributed nationwide in the U.S. and are classified as Class II. No price information is available.

The Hazard

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

Reported Incidents

There have been customer complaints regarding the malfunction of the check valve components. However, no injuries or deaths have been reported.

What to Do

Stop using the affected devices immediately. Follow the recall instructions provided by Medline or your healthcare provider. Contact Medline Industries for further instructions.

Contact Information

For more information, contact Medline Industries, LP. Visit their recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1056-2026 for detailed instructions.

Key Facts

  • 5,314 units recalled
  • Check valves may fail
  • Stop using immediately
  • Contact Medline for instructions
  • No injuries reported

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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 DYKM1980C
UDI/DI 10195327608309 (EA) 40195327608300 (CS)
Lot Number 25JBB147
Lot Number 25KBL305
Medline kit SKU DYKM2137B
+9 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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