Quick Facts at a Glance
- Recall Date
- December 24, 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
- Medical Convenience Kits
- Model numbers
- 1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881, 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827, 3) Kit SKU DT16615, UDI/DI 10653160259268 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 24, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Medline medical convenience kits are used in healthcare settings for dressing changes and to maintain sterile environments during medical procedures. These kits are essential for ensuring patient safety and preventing infections.
Why This Is Dangerous
The hazard arises from the BD ChloraPrep Triple Swabsticks, which may have an open seal that compromises sterility. This can increase the risk of infection during medical procedures if the swabsticks are contaminated.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a considerable number of medical kits that are critical for patient care. Healthcare providers must stop using these kits immediately to prevent potential infections.
Practical Guidance
How to identify if yours is affected
- Verify the Kit SKU against the recalled list
- Check for any visible damage or open seals on the packaging
- Contact your healthcare provider for confirmation
Where to find product info
You can find the SKU and lot numbers on the product packaging or the accompanying documentation.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Follow up with Medline customer service if you do not receive a response within a week
- Document all communication attempts for your records
- Consider filing a complaint with the FDA if issues persist
How to prevent similar issues
- Always check for seals and expiration dates on medical supplies before use
- Purchase from reputable suppliers to ensure product integrity
- Stay informed about recalls for medical products you use
Documentation advice
Keep records of your purchase, any correspondence regarding the recall, and photos of the product for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects specific items including LVAD Dressing Change Tray (SKU DM320C) and Port and IO Access Dressing Kit (SKU DT15780A). These kits were distributed nationwide in the U.S.
Key Facts
- Recall date: December 24, 2025
- Quantity recalled: 8,445 kits
- Classification: Class II
- High hazard level due to potential contamination
- Contact Medline for return instructions
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.