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
- UDI/DI 10889942695911 (EA) 40889942695912 (CA), Lot Numbers: 25JMC398
- 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 Kits containing B. Braun IV Administration Sets are used in medical settings for intravenous delivery of fluids and medications. These kits are essential for various medical procedures, including anesthesia.
Why This Is Dangerous
The check valve component's malfunction can lead to improper fluid flow, which may result in serious medical complications during treatment. This issue could potentially compromise patient safety in critical care environments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease use of the affected kits immediately, which can disrupt medical procedures and treatment plans.
Practical Guidance
How to identify if yours is affected
- Check the product label for SKU PHS972096014B
- Verify lot number: 25JMC398
- Confirm if the product is part of the recall by contacting Medline
Where to find product info
Look for SKU and lot number on the packaging or accompanying documentation of the kit.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document your communications with Medline.
- Consider contacting regulatory bodies for assistance if responses are delayed.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Ensure the products have been certified by relevant health authorities.
Documentation advice
Keep records of your purchase, any correspondence with Medline, and photos of the product for your records.
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Product Details
The recall involves Medline Kits identified as AN01 Carotid Anesth Kit-LF, SKU PHS972096014B. The affected models include UDI/DI 10889942695911 (EA) and 40889942695912 (CA), with lot numbers 25JMC398. The recalled kits are distributed nationwide in the United States.
Key Facts
- Recall date: November 26, 2025
- Distribution: US Nationwide
- Quantity recalled: 10 units
- Class II recall, indicating high risk
- Immediate stop use advised
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Safety Guide
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