Quick Facts at a Glance
- Recall Date
- January 7, 2026
- 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
- Convenience Kits
- Model numbers
- 1) DM1035A, UDI-DI: 10653160345251(each), 00653160345254(case), Lot Number: 2025051290, 2) DM1035A, Lot Number: 2025031190, 3) DM1035A, Lot Number: 2023062390 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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 Convenience Kits are used in healthcare settings for various medical procedures, including dressing changes. They are designed to provide sterile materials necessary for patient care.
Why This Is Dangerous
The recall is due to calibration issues with sterilization equipment, which may compromise the sterility of the products. This raises the risk of infections for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant number of medical kits, potentially endangering patient safety. Immediate action is required to prevent health risks.
Practical Guidance
How to identify if yours is affected
- Check the product model number for DM1035A, DM1035, or DT8670A.
- Verify the lot numbers listed on the product packaging.
- If unsure, contact Medline for verification.
Where to find product info
Model numbers and lot numbers are typically found on the packaging or the product label.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after returning the recalled product.
If the manufacturer is unresponsive
- Contact Medline again to follow up on your request.
- Document all interactions and correspondence for records.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Look for products with clear sterilization certifications.
- Check for recent recalls before purchasing medical devices.
- Consult healthcare providers for recommendations on safe products.
Documentation advice
Keep copies of all communication and any receipts related to the purchase and return of the recalled product.
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Product Details
The recall involves three products: LVAD Driveline Tray (Model DM1035A), LVAD Driveline Tray (Model DM1035), and Central Line Dressing Change Tray (Model DT8670A). These products were distributed worldwide, including the U.S. All kits were exposed to validated sterilization cycles.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 9,720 units
- Class II recall due to potential health risks
- Stop using products immediately
- Contact Medline for further instructions
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Safety Guide
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