High risk Medical DevicesClass II

Medline Dialysis On/Off Kit Recall

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Updated January 8, 2026

Medline Dialysis On/Off Kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking fluid flow during dialysis or causing leakage and therapy delays. This can expose patients to biological contaminants or air infusion into the body.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on January 8, 2026. Details below.

What is recalled

Medline Dialysis On/Off Kit, SKU EBSI1746, containing Tego Connectors with affected silicone seals.

Am I affected

You are affected if you have a Medline Dialysis On/Off Kit with SKU EBSI1746. Check the label on your dialysis connector kit for this SKU number.

What to do right now

Stop using this dialysis kit immediately. Contact Medline Industries, LP to request a replacement kit or return your affected kit. Do not attempt dialysis with a compromised connector.

The hazard

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.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1464-2026
Classification
Class II
Recalled
January 8, 2026
Read the official notice

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