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 ACC010271B, UDI/DI 10193489484953 (EA) 40193489484954 (CS), Lot number 25IDB125, Lot number 25IDB400, Lot number 25JDB835, Lot number 25KDA036, Lot number 25KDA248, Medline kit SKU ACC010416B +2 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 Sets are used in hospitals and healthcare settings for delivering fluids and medications to patients intravenously. These sets are critical for patient care, particularly in surgical and emergency situations.
Why This Is Dangerous
The check valve malfunction could prevent the proper flow of fluids, potentially leading to over-infusion or under-infusion of critical medications, which can endanger patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall presents a high urgency for healthcare providers as the malfunction may lead to serious medical complications during treatment.
Practical Guidance
How to identify if yours is affected
- Locate the SKU number on your IV administration kit packaging.
- Compare the SKU number with those listed in the recall announcement.
- If your kit matches any recalled SKU, stop using the device immediately.
Where to find product info
SKU numbers are typically found on the box or packaging of the Medline kits.
What timeline to expect
Expect a refund or replacement to be processed within 4 to 6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with Medline.
- Reach out to the FDA or CPSC for further assistance.
- Consider consulting a legal professional if necessary.
How to prevent similar issues
- Always check for product recalls before using medical devices.
- Look for safety certifications such as FDA approval on medical products.
- Stay informed about product safety alerts from manufacturers.
Documentation advice
Keep copies of your purchase receipts, any correspondence with the manufacturer, and photographs of the product for your records.
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Product Details
The recall includes Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets. Specific SKUs include ACC010271B, ACC010416B, and others. The kits were distributed nationwide in the U.S.
Key Facts
- Recall date: November 26, 2025
- Quantity recalled: 3,045 units
- Classification: Class II
- Distribution: U.S. Nationwide
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Safety Guide
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