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 Kit
- Model numbers
- UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990
- 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 Medline Dialysis On/Off Kit is designed to assist healthcare providers in administering dialysis treatment to patients. These kits are critical for ensuring safe and effective blood product management during dialysis procedures.
Why This Is Dangerous
Defective silicone seals on the Tego Connectors can lead to fluid leakage or air exposure during dialysis, which may compromise patient safety. This defect can interrupt therapy and delay necessary treatments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on these dialysis kits face potential interruptions in therapy and exposure to health risks, highlighting the urgency for immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Check the kit for the SKU EBSI1746 and affected lot numbers.
- Inspect the silicone seals for any signs of doming or tearing.
- Contact your healthcare provider for assistance in identifying affected products.
Where to find product info
Lot numbers and SKU can typically be found on the packaging of the dialysis kit or on the product label.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all communication with Medline Industries.
- Consider reaching out to the FDA or CPSC if you do not receive a response.
- Keep records of your purchase and any correspondence.
How to prevent similar issues
- Look for medical devices that have clear safety certifications.
- Inquire about product recalls before purchasing medical devices.
- Check product seals and labels for integrity upon receipt.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and photos of the product as evidence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves Medline Dialysis On/Off Kits, SKU EBSI1746, including Tego Connectors. The affected lots are 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, and 2025072990. These kits were distributed nationwide in the United States.
Key Facts
- Recall date: January 8, 2026
- Total quantity recalled: 2,020 kits
- Potential for fluid leakage and contamination
- Affected lots include multiple identifiers
- Issued by Medline Industries, LP
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.