Medline Industries recalled 150 dialysis convenience kits on January 8, 2026, due to silicone seal defects. Affected kits may obstruct fluid paths and risk exposure to biological contaminants.
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.
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
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The recall involves convenience kits containing Tego Connectors, specifically SKU DYNDC3167. The affected lots are 24IME953 and 25CMA708, distributed nationwide.
The silicone seal defects may cause occluded fluid paths, preventing users from injecting or withdrawing blood products. This defect can delay therapy, cause fluid leakage, and expose users to air or biological contaminants.
There have been no deaths reported. However, the potential for serious health risks exists due to the nature of the defects.
Stop using the dialysis kits immediately. Follow the recall instructions provided by Medline and contact your healthcare provider for further guidance.
For more information, contact Medline Industries, LP directly or visit their website. Additional details are available at the FDA recall link.
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