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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.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline kit SKU DYNJ0785864RUDI/DI 10195327656454 (EA) 40195327656455 (CA)Lot Number 25HMB184

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
8/10

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 DYNJ0785864R, UDI/DI 10195327656454 (EA) 40195327656455 (CA), Lot Number 25HMB184, Medline kit SKU DYNJ0792607R, UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.
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

These Medline kits are used to administer intravenous medications and fluids in a healthcare setting. They are essential for patient care, especially in surgical and emergency situations.

Why This Is Dangerous

The defect in the check valve can cause it to become stuck, leading to either no delivery of medication or an uncontrolled flow, which can be dangerous for patients requiring precise dosages.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients relying on these IV administration sets may face serious health risks if the equipment malfunctions, emphasizing the urgency for users to stop using the recalled products.

Practical Guidance

How to identify if yours is affected

  1. Check the SKU number on your Medline kit.
  2. Verify against the affected SKUs: DYNJ0785864R or DYNJ0792607R.
  3. If you have either SKU, your product is affected.

Where to find product info

The SKU number is typically located on the packaging or the product label of the Medline kit.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks after initiating the return process.

If the manufacturer is unresponsive

  • Document your attempts to contact the company.
  • Consider reaching out through multiple contact methods (phone, email).
  • If still unresponsive, file a complaint with the FDA or CPSC.

How to prevent similar issues

  • When purchasing IV administration sets, ensure they meet safety certifications.
  • Look for products with a proven safety record and positive reviews.
  • Consult healthcare providers for recommended brands and models.

Documentation advice

Keep records of your purchase, any correspondence with the company, and photos of the product for your records.

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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.

Key Facts

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

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
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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