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
- Sterilization Kit
- Model numbers
- 1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
- 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
March 4, 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
The Medline Triple Lumen Insertion Kit is a medical device used in various healthcare procedures requiring sterile tools. Consumers typically purchase these kits through medical supply channels for professional use in hospitals and clinics.
Why This Is Dangerous
The calibration issues with sterilization equipment can compromise the sterility of the kits, potentially exposing patients to infection risks during medical procedures. This is particularly concerning in environments where sterility is critical to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may create immediate inconvenience for healthcare providers relying on these kits for patient care. Users must stop utilizing the product and seek alternatives to avoid potential health risks.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled products listed on the FDA website.
- Verify the lot number: 23EBM150 is affected.
- Contact Medline for confirmation if you are unsure.
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 processing for refunds or replacements to take 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Medline through customer service.
- Document your communication attempts for records.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Always check for recalls on medical devices prior to use.
- Ensure the product has up-to-date sterilization certifications and labels.
- Purchase from reputable suppliers with good safety records.
Documentation advice
Keep records of the purchase, any correspondence with the manufacturer, and details of the recall for your reference.
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Product Details
The recalled product is the Triple Lumen Insertion Kit, Model Number DYNDM1031A. It was distributed worldwide, including across the United States. The products were exposed to validated sterilization cycles but may not meet sterility assurance standards.
Key Facts
- Recalled model: DYNDM1031A
- Class II recall
- Calibration issues with sterilization equipment
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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