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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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 DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25HBB410, Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25HBE055, Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS) +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
April 13, 2026
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
Medline IV Administration Kits are used in medical settings to deliver fluids and medications intravenously. Healthcare providers purchase these kits for pre-operative procedures and in-patient care.
Why This Is Dangerous
The check valves in the IV sets may malfunction, causing them to stay either open or closed. This can disrupt the flow of fluids, posing health risks to patients receiving treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare facilities that rely on these kits for patient care. The urgency of the recall is high due to the potential for serious health risks.
Practical Guidance
How to identify if yours is affected
- Locate the SKU number on your product packaging.
- Check against the list of recalled SKUs provided by Medline.
- Inspect the product for any visible damage.
Where to find product info
SKU numbers are typically found on the product packaging and accompanying documentation.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Follow up with Medline Industries via phone or email.
- Document all communication attempts.
How to prevent similar issues
- Check for recalls before purchasing medical devices.
- Ensure products meet safety standards.
- Consult with healthcare providers about alternative products.
Documentation advice
Keep records of receipts, communication with the company, and any medical incidents related to the product.
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Product Details
The recall includes Medline kits with various SKUs such as DYKS1093B and DYKS1124C, among others. The kits were distributed nationwide in the U.S. Specific lot numbers are included in the recall documentation.
Key Facts
- Recalled on November 26, 2025
- Contains B. Braun IV Administration Sets
- High hazard due to check valve malfunction
- Stop using the product immediately
- Contact Medline for further instructions
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Safety Guide
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