HIGH

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.

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 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.

The Hazard

The check valve components in these IV Administration Sets may become stuck in either the open or closed positions. This malfunction poses a high risk to patient safety.

Reported Incidents

There are no specific reported injuries or incidents mentioned, but the potential for serious complications exists due to the malfunctioning components.

What to Do

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

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1060-2026.

Key Facts

  • 338 units recalled
  • Recalled on November 26, 2025
  • Risk of malfunctioning check valves
  • Contact Medline for instructions

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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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