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High risk Medical DevicesClass II

Medline Dialysis Dressing Change Kit Recall

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

Updated January 8, 2026

Medline dialysis dressing change convenience kits with Tego Connectors may have defective silicone seals that can tear or dome, blocking the fluid path and potentially exposing patients to biological contaminants or air infusion during treatment.

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

What is recalled

Convenience kits containing Tego Connectors, Medline Dialysis Dressing Change SKU DYNDC3167.

Am I affected

You're affected if you use Medline dialysis dressing change convenience kits with Tego Connectors (SKU DYNDC3167) that show visible silicone seal damage, doming, or tearing on the connector.

What to do right now

Stop using affected kits immediately. Contact Medline Industries, LP to report the issue and obtain a replacement kit. Do not attempt to use a kit with a damaged or compromised Tego Connector seal.

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

Medline Industries, LP
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1468-2026
Classification
Class II
Recalled
January 8, 2026
Read the official notice

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