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Medline Dialysis Insertion Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Dialysis Insertion Kits

Medline is recalling dialysis insertion kits due to potential silicone seal defects in Tego Connectors that may cause leaks or therapy delays.

What to do

Immediately stop using the affected kits and contact Medline Industries, LP for further instructions regarding the return or disposal of the product.

Posted
Updated
Recall No.
Z-1465-2026
Agency
Firm
Medline Industries, LP
Recall ID
98333
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 10653160383628 00653160383621 2024121390 2025033190 10653160368755 00653160368758 2025041090 10653160374978

Convenience kits used for dialysis maintenance

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification