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 SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100, Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736, Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS) +10 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
IV administration sets are critical medical devices used to deliver fluids and medications directly into a patient's bloodstream. Healthcare providers rely on these sets for patient care during surgeries and other medical procedures.
Why This Is Dangerous
The potential malfunction of the check valves in these IV sets can lead to serious medical risks, including interruption of medication delivery or unintended backflow of fluids, which can compromise patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face immediate risks if they continue to use the affected products. The urgency of the recall highlights the importance of ensuring the safety and functionality of medical devices.
Practical Guidance
How to identify if yours is affected
- Check the SKU number on the packaging of your IV administration set against the recalled SKUs listed in the recall notice.
- Look for the lot numbers printed on the product to confirm if it is affected.
- If unsure, contact Medline Industries or your healthcare provider for clarification.
Where to find product info
SKU numbers and lot numbers are typically printed on the product packaging or the label attached to the IV administration set.
What timeline to expect
You can expect a refund or replacement to be processed within 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Contact the Consumer Product Safety Commission for additional assistance if necessary.
How to prevent similar issues
- When purchasing medical devices, ensure they are from reputable manufacturers with strong safety records.
- Check for the latest recall information before using any medical device.
- Look for safety certifications and compliance with industry standards.
Documentation advice
Keep a record of all correspondence regarding the recall, including emails and letters, as well as any receipts or proof of purchase.
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Product Details
The recall includes Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets, with SKUs such as CDS984289O and CDS984355K. These kits were distributed nationwide in the United States.
Key Facts
- Check valve may become stuck
- Stop using immediately
- Contact Medline for instructions
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Safety Guide
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