HIGH

Medline Recalls IV Administration Sets Over Valve Malfunction Risk

Medline Industries recalled 96 IV administration sets on November 26, 2025, due to a defect in the check valve. The defect can cause the valves to become stuck, posing a high risk for patients. Users should stop using the products immediately and follow the recall instructions.

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 affects Medline kits containing B. Braun IV Administration Sets, specifically the RR-LE Fort Mandible Pack (SKU DYNJ0785864R) and RR-ASC Ear Pack (SKU DYNJ0792607R). These kits 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 position. This malfunction can lead to improper medication delivery, putting patients at serious risk.

Reported Incidents

Currently, there are no reported injuries or deaths associated with this recall. However, the high-risk nature of the defect requires immediate action from users.

What to Do

Stop using the recalled Medline kits immediately. Follow the recall instructions sent by Medline Industries and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Medline Industries, LP at [insert phone number]. Visit the FDA website for details on the recall.

Key Facts

  • 96 units recalled
  • Check valve defect may cause medication delivery issues
  • Affected SKUs: DYNJ0785864R, DYNJ0792607R
  • Nationwide distribution in the U.S.

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Administration Sets
Sold At
Multiple Retailers

Product Details

Model Numbers
Medline kit SKU DYNJ0785864R
UDI/DI 10195327656454 (EA) 40195327656455 (CA)
Lot Number 25HMB184
Medline kit SKU DYNJ0792607R
UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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