FDAJanuary 8, 2026device

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion ...

Official recall recorded by the U.S. Food & Drug Administration.

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.

What to do

FDA enforcement status: Ongoing

Brands named

medline industries lpmedlinemedline industries

UPCs

101934891115382019348911153510889942723508408899427235091065316035716200653160357165106531603796380065316037963110653160386735006531603867381065316034534300653160345346

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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