Quick Facts at a Glance
- Recall Date
- January 8, 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
- Dialysis Convenience Kit
- Model numbers
- UDI-DI (ea) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 8, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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 dialysis convenience kits are used in medical settings for blood product management in patients undergoing dialysis. They are essential for ensuring the safe delivery and withdrawal of blood products during treatment.
Why This Is Dangerous
The silicone seal defects can cause blockages in fluid paths, meaning healthcare providers may not be able to inject or withdraw necessary blood products, leading to critical delays in patient care.
Industry Context
This recall is not part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Check the SKU number DYNDC3167
- Verify lot numbers 24IME953 and 25CMA708 on the packaging
- Inspect for any visible damage to the silicone seals
Where to find product info
The SKU and lot numbers are typically printed on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Medline Industries customer service for updates
- Document all communication attempts
- Consider filing a complaint with the FDA if unresponsive
How to prevent similar issues
- Always check for recalls before purchasing medical devices
- Look for certifications on medical products
- Consult healthcare providers about product safety
Documentation advice
Keep records of all communications with Medline and any documentation related to the recall, including receipts and product photos.
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Product Details
The recall involves convenience kits containing Tego Connectors, specifically SKU DYNDC3167. The affected lots are 24IME953 and 25CMA708, distributed nationwide.
Key Facts
- Recalls 150 dialysis convenience kits
- Hazard due to silicone seal defects
- Risk of therapy interruption and contamination
- Affected SKU: DYNDC3167
- Contact Medline for further instructions
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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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